Flag of the European Union

EU Clinical Trials Register

Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 43857 clinical trials with a EudraCT protocol, of which 7284 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

Examples: Cancer AND drug name. Pneumonia AND sponsor name.
How to search [pdf]

Advanced Search:

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

< Back to search results

Clinical Trial Results:
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

Summary
EudraCT number	2010-021196-85
Trial protocol	GB ES BE EE IS DE DK NL PL
Global end of trial date	02 Oct 2017

Results information
Results version number	v1(current)
This version publication date	04 Jan 2019
First version publication date	04 Jan 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

BNIT-PRV-301

ISRCTN number

-

US NCT number

NCT01322490

WHO universal trial number (UTN)

-

Sponsor organisation name

Bavarian Nordic, Inc.

Sponsor organisation address

3025 Carrington Mill Blvd, Suite 100, Morrisville, NC, United States, 27560

Public contact

Cesar Pico-Navarro, Bavarian Nordic, Inc., +34 628 748 006, Cesar.Pico-Navarro@bavarian-nordic.com

Scientific contact

Cesar Pico-Navarro, Bavarian Nordic, Inc., +34 628 748 006, Cesar.Pico-Navarro@bavarian-nordic.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

02 Oct 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

26 Jun 2015

Global end of trial reached?

Yes

Global end of trial date

02 Oct 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

To ascertain whether the survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).

Protection of trial subjects

The investigator ensured that this clinical trial was conducted in complete accordance with the provisions of the Declaration of Helsinki (1996), the national laws and other guidelines for the conduct of clinical trials, like the ICH Harmonized Tripartite Guideline for Good Clinical Practice (GCP), to guarantee the greatest subject protection possible. Subjects had to be informed unequivocally that they were able to refuse participation in the trial, that they were able to withdraw from the trial at any time and for whatever reason, and that withdrawal of consent did not affect their subsequent medical treatment or relationship with the treating physician.

Background therapy

-

Evidence for comparator

The trial was designed to evaluate overall survival (OS) in two separate comparisons: PROSTVAC + GM-CSF versus control, and PROSTVAC without GM-CSF versus control.

Actual start date of recruitment

28 Nov 2011

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

27 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 101

Country: Number of subjects enrolled

Canada: 69

Country: Number of subjects enrolled

Israel: 29

Country: Number of subjects enrolled

Puerto Rico: 5

Country: Number of subjects enrolled

Russian Federation: 163

Country: Number of subjects enrolled

United States: 394

Country: Number of subjects enrolled

Netherlands: 16

Country: Number of subjects enrolled

Poland: 20

Country: Number of subjects enrolled

Spain: 126

Country: Number of subjects enrolled

United Kingdom: 99

Country: Number of subjects enrolled

Belgium: 30

Country: Number of subjects enrolled

Denmark: 108

Country: Number of subjects enrolled

Estonia: 20

Country: Number of subjects enrolled

France: 85

Country: Number of subjects enrolled

Germany: 22

Country: Number of subjects enrolled

Iceland: 10

Worldwide total number of subjects

1297

EEA total number of subjects

536

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

272

From 65 to 84 years

965

85 years and over

60

Subject disposition

Top of page

Recruitment details

The study population for the trial was intended to approximate the population enrolled in the randomized phase 2 trial in which an overall survival advantage was observed. Clinical trial data supported the hypothesis that patients with less aggressive and lower burden disease were more likely to benefit from therapeutic cancer vaccines.

Screening details

Screening activities were completed within 28 days prior to the first dose of any study medication - between days -28 and -1 (Week -4 to Week 0), and were completed prior to dosing.

Period 1 title

Treatment Phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Assessor

Blinding implementation details

The trial was conducted in a double-blind manner. Subjects and investigators were blinded as to their specific treatment assignment. The sponsor controlled and documented any disclosure of treatment assignments. These procedures ensured that neither the sponsor’s monitoring staff nor the investigator nor other site staff had premature access to individual subject treatment assignment.

Are arms mutually exclusive

Yes

Arm VG (PROSTVAC + GM-CSF)

Arm description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a SC GM-CSF on the day of immunization and for the subsequent three days (SC GM-CSF injection within 5 mm of the original PROSTVAC injection site).

Arm type

Experimental

Investigational medicinal product name

PROSTVAC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PROSTVAC-V for SC injection was 0.5 mL and contained at least 2 x 108 Inf.U PROSTVAC-V. PROSTVAC-F for SC injection was 0.5 mL and contained at least 1 x 109 Inf.U PROSTVAC-F.

Investigational medicinal product name

GM-CSF

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF (sargramostim; Leukine®: 250 μg, lyophilized) is a glycosylated, recombinant human GM-CSF. Lyophilized GM-CSF was reconstituted using 1.0 mL of room-temperature bacteriostatic water for injection (USP-grade or equivalent). Each 100 μg doses of GM-CSF was drawn into labeled syringes by an independent, unblinded research pharmacist or designee for use by the clinic staff or for use by individual subjects for home injection.

Arm V (PROSTVAC + GM-CSF placebo)

Arm description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a GM-CSF placebo on the day of immunization and for the subsequent three days.

Arm type

Experimental

Investigational medicinal product name

PROSTVAC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PROSTVAC-V for SC injection was 0.5 mL and contained at least 2 x 108 Inf.U PROSTVAC-V. PROSTVAC-F for SC injection was 0.5 mL and contained at least 1 x 109 Inf.U PROSTVAC-F.

Investigational medicinal product name

GM-CSF placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF placebo was USP-grade or equivalent bacteriostatic sodium chloride (saline) for injection.

Arm P (Vaccine placebo + GM-CSF placebo)

Arm description

The trial treatment consisted of a single Vaccine placebo injection on Day 1 (Week 1), followed by six GM-CSF placebo injections: one injection administered at each of Weeks 3, 5, 9, 13, 17, and 21. Each Vaccine placebo injection was accompanied by administration of an GM-CSF placebo injection on the day of immunization and for three subsequent days (placebo SC injection within 5 mm of the original placebo injection site).

Arm type

Placebo

Investigational medicinal product name

Vaccine placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Vaccine placebo is empty fowlpox vector matching PROSTVAC.

Investigational medicinal product name

GM-CSF placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF placebo was USP-grade or equivalent bacteriostatic sodium chloride (saline) for injection.

Number of subjects in period 1	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)
Started	432	432	433
Completed	279	300	280
Not completed	153	132	153
Adverse event, serious fatal	7	5	3
Physician decision	2	-	1
Consent withdrawn by subject	16	14	11
Non-Compliance	-	-	1
Adverse event, non-fatal	18	12	15
Randomized but not treated	3	3	5
Other	2	2	1
Progressive Disease	100	89	112
Protocol deviation	5	7	4

Period 2 title

Long-term Follow-up (LTFU)

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Assessor

Are arms mutually exclusive

Yes

Arm VG (PROSTVAC + GM-CSF)

Arm description

Following the completion of the treatment phase, all subjects from Arm VG (PROSTVAC + GM-CSF) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Arm type

Experimental

Investigational medicinal product name

PROSTVAC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PROSTVAC-V for SC injection was 0.5 mL and contained at least 2 x 108 Inf.U PROSTVAC-V. PROSTVAC-F for SC injection was 0.5 mL and contained at least 1 x 109 Inf.U PROSTVAC-F.

Investigational medicinal product name

GM-CSF

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF (sargramostim; Leukine®: 250 μg, lyophilized) is a glycosylated, recombinant human GM-CSF. Lyophilized GM-CSF was reconstituted using 1.0 mL of room-temperature bacteriostatic water for injection (USP-grade or equivalent). Each 100 μg doses of GM-CSF was drawn into labeled syringes by an independent, unblinded research pharmacist or designee for use by the clinic staff or for use by individual subjects for home injection.

Arm V (PROSTVAC + GM-CSF placebo)

Arm description

Following the completion of the treatment phase, all subjects from Arm V (PROSTVAC + GM-CSF placebo) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Arm type

Experimental

Investigational medicinal product name

PROSTVAC

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

PROSTVAC-V for SC injection was 0.5 mL and contained at least 2 x 108 Inf.U PROSTVAC-V. PROSTVAC-F for SC injection was 0.5 mL and contained at least 1 x 109 Inf.U PROSTVAC-F.

Investigational medicinal product name

GM-CSF placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF placebo was USP-grade or equivalent bacteriostatic sodium chloride (saline) for injection.

Arm P (Vaccine placebo + GM-CSF placebo)

Arm description

Following the completion of the treatment phase, all subjects from Arm P (Vaccine placebo + GM-CSF placebo) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Arm type

Placebo

Investigational medicinal product name

Vaccine placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Vaccine placebo is empty fowlpox vector matching PROSTVAC.

Investigational medicinal product name

GM-CSF placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

GM-CSF placebo was USP-grade or equivalent bacteriostatic sodium chloride (saline) for injection.

Number of subjects in period 2	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)
Started	279	300	280
Completed	0	0	0
Not completed	408	409	413
Consent withdrawn by subject	6	9	6
Death	239	235	236
Other	2	3	2
Study Terminated by Sponsor	158	160	165
Lost to follow-up	2	2	3
Missing	1	-	1
Joined	129	109	133
Subjects Agreed to Continue into LTFU Phase	129	109	133

Baseline characteristics

Top of page

Reporting group title

Arm VG (PROSTVAC + GM-CSF)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a SC GM-CSF on the day of immunization and for the subsequent three days (SC GM-CSF injection within 5 mm of the original PROSTVAC injection site).

Reporting group title

Arm V (PROSTVAC + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a GM-CSF placebo on the day of immunization and for the subsequent three days.

Reporting group title

Arm P (Vaccine placebo + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single Vaccine placebo injection on Day 1 (Week 1), followed by six GM-CSF placebo injections: one injection administered at each of Weeks 3, 5, 9, 13, 17, and 21. Each Vaccine placebo injection was accompanied by administration of an GM-CSF placebo injection on the day of immunization and for three subsequent days (placebo SC injection within 5 mm of the original placebo injection site).

Reporting group values	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)	Total
Number of subjects	432	432	433	1297
Age categorical
Units: Subjects
Adults (18-64 years)	93	88	91	272
From 65-84 years	322	325	318	965
85 years and over	17	19	24	60
Age continuous
Units: years
arithmetic mean (full range (min-max))	70.6 (45 to 90)	71.3 (49 to 90)	71.3 (46 to 93)	-
Gender categorical
Units: Subjects
Female	0	0	0	0
Male	432	432	433	1297

Subject analysis set title

Intent-to-Treat Set (ITT set)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Intent-to-Treat Set (ITT Set) included all subjects who were randomized.

Subject analysis set title

FAS (Full Analysis Set)

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set (FAS) included all subjects who initiated trial treatment.

Subject analysis set title

Safety Analysis Set

Subject analysis set type

Safety analysis

Subject analysis set description

Safety Analysis Set included all subjects who initiated trial treatment.

Subject analysis sets values	Intent-to-Treat Set (ITT set)	FAS (Full Analysis Set)	Safety Analysis Set
Number of subjects	1297	1286	1286
Age categorical
Units: Subjects
Adults (18-64 years)	272	271	271
From 65-84 years	965	956	956
85 years and over	60	59	59
Age continuous
Units: years
arithmetic mean (full range (min-max))	71.1 (45 to 93)	71.1 (45 to 93)	71.1 (45 to 93)
Gender categorical
Units: Subjects
Female	0	0	0
Male	1297	1286	1286

End points

Top of page

Reporting group title

Arm VG (PROSTVAC + GM-CSF)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a SC GM-CSF on the day of immunization and for the subsequent three days (SC GM-CSF injection within 5 mm of the original PROSTVAC injection site).

Reporting group title

Arm V (PROSTVAC + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a GM-CSF placebo on the day of immunization and for the subsequent three days.

Reporting group title

Arm P (Vaccine placebo + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single Vaccine placebo injection on Day 1 (Week 1), followed by six GM-CSF placebo injections: one injection administered at each of Weeks 3, 5, 9, 13, 17, and 21. Each Vaccine placebo injection was accompanied by administration of an GM-CSF placebo injection on the day of immunization and for three subsequent days (placebo SC injection within 5 mm of the original placebo injection site).

Reporting group title

Arm VG (PROSTVAC + GM-CSF)

Reporting group description

Following the completion of the treatment phase, all subjects from Arm VG (PROSTVAC + GM-CSF) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Reporting group title

Arm V (PROSTVAC + GM-CSF placebo)

Reporting group description

Following the completion of the treatment phase, all subjects from Arm V (PROSTVAC + GM-CSF placebo) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Reporting group title

Arm P (Vaccine placebo + GM-CSF placebo)

Reporting group description

Following the completion of the treatment phase, all subjects from Arm P (Vaccine placebo + GM-CSF placebo) automatically entered the LTFU Phase, during which trial visits occurred every 6 months and subjects received standard-of-care treatment as determined by the investigator or treating physician. All subjects are followed for 12 months after the required number of 534 events for each between-arm comparison was reached. Concomitant medications, subject health status, disease status, newly diagnosed autoimmune diseases, and subsequent prostate cancer therapies were collected at each six-month LTFU visit.

Subject analysis set title

Intent-to-Treat Set (ITT set)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Intent-to-Treat Set (ITT Set) included all subjects who were randomized.

Subject analysis set title

FAS (Full Analysis Set)

Subject analysis set type

Full analysis

Subject analysis set description

Full Analysis Set (FAS) included all subjects who initiated trial treatment.

Subject analysis set title

Safety Analysis Set

Subject analysis set type

Safety analysis

Subject analysis set description

Safety Analysis Set included all subjects who initiated trial treatment.

Primary: Overall Survival (OS)

Top of page

End point title

Overall Survival (OS)

End point description

The primacy efficacy endpoint for the trial was OS. The survival analysis objective was to ascertain whether the survival-time distribution for subjects randomized to the investigational arm was consistent with longer survival compared to subjects randomized to the control arm. Two main overall comparisons of survival time were planned: a comparison between Arm VG and Arm P, and a comparison between Arm V and Arm P.

End point type

Primary

End point timeframe

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.

End point values	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)
Number of subjects analysed	432	432	433
Units: Months
median (confidence interval 95%)
Overall Survival (months)	33.2 (30.6 to 37.4)	34.4 (31 to 36.9)	34.3 (30.7 to 37.0)

Statistical Analysis Plan (SAP) - Arm VG v. Arm P

Comparison groups

Arm P (Vaccine placebo + GM-CSF placebo) v Arm VG (PROSTVAC + GM-CSF)

Number of subjects included in analysis

865

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.5885

Method

Logrank

Confidence interval

Notes
[1] - Overall survival is calculated as the date of (death/censoring - date of randomization + 1)/30.4375. Subjects who did not die are censored at last known alive date or datacut off date, whichever comes first. Quartiles and 95% CI are estimated using Kaplan-Meier methods. The 95% confidence intervals for the median OS times was calculated using the method by Brookmeyer and Crowley.

Statistical Analysis Plan (SAP) - Arm V v. Arm P

Comparison groups

Arm V (PROSTVAC + GM-CSF placebo) v Arm P (Vaccine placebo + GM-CSF placebo)

Number of subjects included in analysis

865

Analysis specification

Pre-specified

Analysis type

superiority ^[2]

P-value

= 0.4742

Method

Logrank

Confidence interval

Notes
[2] - Overall survival is calculated as the date of (death/censoring - date of randomization + 1)/30.4375. Subjects who did not die are censored at last known alive date or datacut off date, whichever comes first. Quartiles and 95% CI are estimated using Kaplan-Meier methods. The 95% confidence intervals for the median OS times was calculated using the method by Brookmeyer and Crowley.

Adverse events

Top of page

Timeframe for reporting adverse events

The collection of AEs occurred from the signing of informed consent to 28 days following the administration of the last dose of study medication, which was approximately the Week 25/End of Treatment Visit for subjects who completed the treatment period.

Adverse event reporting additional description

Serious Adverse Events (SAEs) if ongoing at the End of Treatment visit were followed to resolution or until the investigator assessed the subject as stable. SAEs that were reported after the end of the treatment period were collected only if they were assessed by the investigator as being possibly or definitely related to study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Arm VG (PROSTVAC + GM-CSF)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a SC GM-CSF on the day of immunization and for the subsequent three days (SC GM-CSF injection within 5 mm of the original PROSTVAC injection site).

Reporting group title

Arm V (PROSTVAC + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single SC injection of PROSTVAC-V on day 0 (Week 1), followed by six PROSTVAC-F injections: each administered at days 14 (Week 3), 28 (Week 5), 56 (Week 9), 84 (Week 13), 112 (Week 17), and 140 (Week 21). Each PROSTVAC injection was accompanied by a GM-CSF placebo on the day of immunization and for the subsequent three days.

Reporting group title

Arm P (Vaccine placebo + GM-CSF placebo)

Reporting group description

The trial treatment consisted of a single Vaccine placebo injection on Day 1 (Week 1), followed by six GM-CSF placebo injections: one injection administered at each of Weeks 3, 5, 9, 13, 17, and 21. Each Vaccine placebo injection was accompanied by administration of an GM-CSF placebo injection on the day of immunization and for three subsequent days (placebo SC injection within 5 mm of the original placebo injection site).

Serious adverse events	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)
Total subjects affected by serious adverse events
subjects affected / exposed	56 / 429 (13.05%)	56 / 429 (13.05%)	53 / 428 (12.38%)
number of deaths (all causes)	254	251	245
number of deaths resulting from adverse events	5	5	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon cancer
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm malignant
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Metastases to central nervous system
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Metastases to meninges
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metastatic pain
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuroendocrine carcinoma of the skin
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal cell carcinoma
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour pain
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Aortic aneurysm
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Aortic stenosis
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intermittent claudication
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphoedema
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular compression
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
General physical health deterioration
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pain
subjects affected / exposed	2 / 429 (0.47%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 429 (0.23%)	5 / 429 (1.17%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Pulmonary oedema
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Delirium
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Blood creatinine increased
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Brain herniation
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervical vertebral fracture
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cystitis radiation
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fall
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic haematoma
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural haematuria
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiation oesophagitis
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal cord injury
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular bypass dysfunction
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Arrhythmia supraventricular
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	3 / 428 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 429 (0.23%)	2 / 429 (0.47%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Carotid artery stenosis
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebral haematoma
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Cerebral haemorrhage
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 1
Cerebrovascular accident
subjects affected / exposed	2 / 429 (0.47%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 2	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Cervical cord compression
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 429 (0.47%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Nerve compression
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral motor neuropathy
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal cord compression
subjects affected / exposed	4 / 429 (0.93%)	1 / 429 (0.23%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Disseminated intravascular coagulation
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile neutropenia
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemolytic uraemic syndrome
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Histiocytosis haematophagic
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Normochromic normocytic anaemia
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Eye disorders
Retinal detachment
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal haemorrhage
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia strangulated
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oesophageal varices haemorrhage
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Proctitis
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 429 (0.00%)	2 / 429 (0.47%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysuria
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	7 / 429 (1.63%)	2 / 429 (0.47%)	4 / 428 (0.93%)
occurrences causally related to treatment / all	0 / 7	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	1 / 429 (0.23%)	5 / 429 (1.17%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 5	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Obstructive uropathy
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelocaliectasis
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 429 (0.00%)	2 / 429 (0.47%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Ureteric obstruction
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urethral stenosis
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary bladder haemorrhage
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary retention
subjects affected / exposed	4 / 429 (0.93%)	6 / 429 (1.40%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 4	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	2 / 429 (0.47%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bone pain
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rhabdomyolysis
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Appendiceal abscess
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacterial infection
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Catheter site infection
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lobar pneumonia
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oral candidiasis
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Perinephric abscess
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 429 (0.47%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 429 (0.23%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spinal cord infection
subjects affected / exposed	2 / 429 (0.47%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 429 (0.00%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	3 / 429 (0.70%)	1 / 429 (0.23%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 429 (0.00%)	2 / 429 (0.47%)	2 / 428 (0.47%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Cell death
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dehydration
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	1 / 428 (0.23%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes mellitus
subjects affected / exposed	0 / 429 (0.00%)	1 / 429 (0.23%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 429 (0.23%)	0 / 429 (0.00%)	0 / 428 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Arm VG (PROSTVAC + GM-CSF)	Arm V (PROSTVAC + GM-CSF placebo)	Arm P (Vaccine placebo + GM-CSF placebo)
Total subjects affected by non serious adverse events
subjects affected / exposed	395 / 429 (92.07%)	386 / 429 (89.98%)	385 / 428 (89.95%)
Vascular disorders
Hypertension
subjects affected / exposed	23 / 429 (5.36%)	28 / 429 (6.53%)	22 / 428 (5.14%)
occurrences all number	23	28	22
Hot flush
subjects affected / exposed	20 / 429 (4.66%)	23 / 429 (5.36%)	12 / 428 (2.80%)
occurrences all number	20	23	12
Nervous system disorders
Headache
subjects affected / exposed	43 / 429 (10.02%)	32 / 429 (7.46%)	36 / 428 (8.41%)
occurrences all number	43	32	36
Dizziness
subjects affected / exposed	17 / 429 (3.96%)	18 / 429 (4.20%)	22 / 428 (5.14%)
occurrences all number	17	18	22
General disorders and administration site conditions
Injection site erythema
subjects affected / exposed	258 / 429 (60.14%)	202 / 429 (47.09%)	203 / 428 (47.43%)
occurrences all number	258	202	203
Injection site pain
subjects affected / exposed	131 / 429 (30.54%)	111 / 429 (25.87%)	122 / 428 (28.50%)
occurrences all number	131	111	122
Fatigue
subjects affected / exposed	105 / 429 (24.48%)	94 / 429 (21.91%)	91 / 428 (21.26%)
occurrences all number	105	94	91
Injection site pruritus
subjects affected / exposed	109 / 429 (25.41%)	77 / 429 (17.95%)	57 / 428 (13.32%)
occurrences all number	109	77	57
Injection site swelling
subjects affected / exposed	101 / 429 (23.54%)	73 / 429 (17.02%)	69 / 428 (16.12%)
occurrences all number	101	73	69
Pyrexia
subjects affected / exposed	91 / 429 (21.21%)	38 / 429 (8.86%)	53 / 428 (12.38%)
occurrences all number	91	38	53
Injection site induration
subjects affected / exposed	67 / 429 (15.62%)	47 / 429 (10.96%)	60 / 428 (14.02%)
occurrences all number	67	47	60
Influenza like illness
subjects affected / exposed	55 / 429 (12.82%)	44 / 429 (10.26%)	36 / 428 (8.41%)
occurrences all number	55	44	36
Asthenia
subjects affected / exposed	37 / 429 (8.62%)	32 / 429 (7.46%)	49 / 428 (11.45%)
occurrences all number	37	32	49
Chills
subjects affected / exposed	44 / 429 (10.26%)	34 / 429 (7.93%)	35 / 428 (8.18%)
occurrences all number	44	34	35
Injection site oedema
subjects affected / exposed	24 / 429 (5.59%)	22 / 429 (5.13%)	20 / 428 (4.67%)
occurrences all number	24	22	20
Injection site warmth
subjects affected / exposed	28 / 429 (6.53%)	15 / 429 (3.50%)	23 / 428 (5.37%)
occurrences all number	28	15	23
Pain in extremity
subjects affected / exposed	28 / 429 (6.53%)	28 / 429 (6.53%)	23 / 428 (5.37%)
occurrences all number	28	28	23
Oedema peripheral
subjects affected / exposed	24 / 429 (5.59%)	21 / 429 (4.90%)	12 / 428 (2.80%)
occurrences all number	24	21	12
Gastrointestinal disorders
Nausea
subjects affected / exposed	51 / 429 (11.89%)	51 / 429 (11.89%)	38 / 428 (8.88%)
occurrences all number	51	51	38
Constipation
subjects affected / exposed	26 / 429 (6.06%)	39 / 429 (9.09%)	29 / 428 (6.78%)
occurrences all number	26	39	29
Diarrhoea
subjects affected / exposed	29 / 429 (6.76%)	38 / 429 (8.86%)	21 / 428 (4.91%)
occurrences all number	29	38	21
Vomiting
subjects affected / exposed	21 / 429 (4.90%)	22 / 429 (5.13%)	17 / 428 (3.97%)
occurrences all number	21	22	17
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	20 / 429 (4.66%)	25 / 429 (5.83%)	15 / 428 (3.50%)
occurrences all number	20	25	15
Renal and urinary disorders
Haematuria
subjects affected / exposed	18 / 429 (4.20%)	21 / 429 (4.90%)	22 / 428 (5.14%)
occurrences all number	18	21	22
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	50 / 429 (11.66%)	49 / 429 (11.42%)	55 / 428 (12.85%)
occurrences all number	50	49	55
Back pain
subjects affected / exposed	43 / 429 (10.02%)	62 / 429 (14.45%)	49 / 428 (11.45%)
occurrences all number	43	62	49
Myalgia
subjects affected / exposed	35 / 429 (8.16%)	36 / 429 (8.39%)	43 / 428 (10.05%)
occurrences all number	35	36	43
Musculoskeletal pain
subjects affected / exposed	28 / 429 (6.53%)	15 / 429 (3.50%)	21 / 428 (4.91%)
occurrences all number	28	15	21
Infections and infestations
Urinary tract infection
subjects affected / exposed	18 / 429 (4.20%)	23 / 429 (5.36%)	23 / 428 (5.37%)
occurrences all number	18	23	23
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	25 / 429 (5.83%)	39 / 429 (9.09%)	31 / 428 (7.24%)
occurrences all number	25	39	31

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

02 May 2011

Amendment 1 (dated 02 May 2011) clarified the vaccine nomenclature for consistency with all publications and trial support documents (e.g., IB, Trial Instruction Manual, etc.); changed the definition of excluded/concomitant therapies to exclude the use of secondary hormonal therapies during the Treatment Phase of the trial, and allowed the use of denosumab; restated Inclusion Criterion #5 as Exclusion Criterion #5; specified exclusion of patients receiving an investigational agent within 60 days of the first planned dose of PROSTVAC; added definition of overdose; corrected dosing information for GM-CSF; and administrative changes.

17 Jun 2011

Amendment 2 (dated 17 June 2011) clarified the vaccine placebo nomenclature for consistency throughout the protocol; added a placebo rationale; added language to specify who can fill syringes with investigational drug product; added Exclusion Criterion #15 and changed Exclusion Criterion #16; clarified scheduled opioid narcotic relief as a trigger for subject removal from therapy or assessment; clarified that diluent for GM-CSF and GM-CSF placebo was bacteriostatic water for injection; added explanation that laboratory procedures not routinely covered by a site’s designated laboratory must be reviewed for approval by the sponsor; clarified use of a central radiological review; added language to explain use of biomarkers; clarified that peripheral blood RNA samples would be collected; and administrative changes.

12 Sep 2011

Amendment 3 (dated 12 September 2011) (first subject enrolled in Dec 2011) the GM-CSF reconstitution volume was changed to reflect the volumes suggested in the manufacturer’s package insert; changed the GM-CSF placebo from bacteriostatic water to bacteriostatic saline; inclusion/exclusion criteria were clarified to maintain consistency with other parts of the protocol and to correct incorrectly stated units; added language to define/clarify that QOL instruments were applied where available; clarified footnote for laboratory tests to state that both troponin tests were preferred, but if only one of the troponin tests could be run, that would be accepted; added the explicit requirement for virology testing; added a specific requirement for a medical history update for newly diagnosed autoimmune diseases during LTFU; updated background material to include newly approved therapies and literature references; and administrative changes.

01 Feb 2012

Amendment 4 (dated 01 February 2012) revised sponsor contact information; clarified excluded chronic corticosteroid therapy; clarified Inclusion Criterion #4; revised the handling of used trial drug vials and syringes; clarified injection site management; added the QEQ-5D-3L to the QOL instruments; added the FACT-P, BPI-SF, and EQ-5D-3L to the LTFU; added calcium to the chemistry assay; clarified the sample collection time for the immune monitoring samples; revised drug accountability and reconciliation for PROSTVAC and GM-CSF to be performed by an unblinded monitor; clarified that vial numbers were recorded for drug accountability for PROSTVAC and lot numbers for GM-CSF; clarified procedures for re-screening; clarified definition of an SAE; and administrative changes.

30 May 2012

Amendment 5 (dated 30 May 2012) made changes for clarity and consistency and updated language to reflect that currently used in the field; affirmed the sponsor’s commitment to compliance with ICH/ European Medicines Agency and applicable regulations; and administrative changes; updated synopsis to match protocol body; minor language revisions, updated language for consistency with IB, removed upper age limit for subjects; added language that subjects must have documented asymptomatic or minimally symptomatic mCRPC; removed language that was within the pharmacy manual and replaced with reference to the pharmacy manual; removed references to the digital; thermometer and subject diary; added section for emergency procedures; listed examples of concurrent immunotherapy and immunosuppressive therapy; moved immune monitoring assessments from screening to day 1; removed hematology and serum chemistry from LTFU; clarified that LTFU surveys would only be completed at the first LTFU visit; removed text pertaining to a local laboratory; more clearly defined AEs; added reference to pregnant partner and informed consent; made consistent with the current Management Plan for Potential Serious Vaccinia Reaction; added new section to provide greater detail regarding the key elements of ICH E2A; added new section to provide greater detail regarding documenting and reporting of AEs and SAEs in accordance with applicable global regulations; and administrative changes.

20 Aug 2015

Amendment 6 (dated 20 August 2015) included revision to the LTFU data collection process to increase subject retention; revision to biological and immune response assessments supporting exploratory endpoints; addition of language to clarify AE/SAE reporting requirements pertaining to progression of underlying malignancy; revised definition of analysis sets in Statistical Analysis section to align with SAP; incorporation of France- and Germany-specific protocol amendment language; and administrative changes.

07 Feb 2017

Amendment 7 (dated 07 February 2017) was an administrative amendment to address feedback from the Paul-Ehrlich-Institut (PEI) in Germany, who requested that the study protocol be updated to contain details regarding the Interim Analyses described in the Statistical Analysis Plan for this study. There is no impact to study design, conduct, or endpoints as a result of the language provided in protocol Section 9.8, Interim Analyses. In addition, the sponsor address and medical monitor have been updated.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The study has discontinued due to futility.

For support, Contact us.

The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

European Medicines Agency © 1995-Thu Apr 25 09:19:50 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands