Clinical Trial Results:
Radium-223 in patients with PSA progression and without clinical
metastases following maximal local therapy: a pilot study
Summary
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EudraCT number |
2014-002833-70 |
Trial protocol |
BE |
Global end of trial date |
12 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Dec 2021
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First version publication date |
22 Dec 2021
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Other versions |
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Summary report(s) |
manuscript |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
s56892
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
UZ Leuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Clinical Trial Center (CTC), UZLeuven, 0032 16341998, CTC@uzleuven.be
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Scientific contact |
Clinical Trial Center (CTC), UZLeuven, 0032 16341998, CTC@uzleuven.be
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Feb 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Dec 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Dec 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the clinical safety/tolerability of Radium-223 treatment in
patients affected by prostate cancer with biochemical relapse after
maximal local treatment with high risk of metastatic progression. Safety
and feasibility results could be used to plan an eventual phase II/III
trial.
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Protection of trial subjects |
Subjects had to sign informed consent before starting the study and could leave the study at any time. Subjects were followed clinically by dedicated medical staff and they had free and direct contact with the clinical trial staff in order to permit them to solve any personal, clinical or administrative issue. Patients could contact the medical staff at any time.
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Background therapy |
- | ||
Evidence for comparator |
/ | ||
Actual start date of recruitment |
25 Apr 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
8 patients included in the study at UZLeuven between April 2016 and December 2017. | ||||||
Pre-assignment
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Screening details |
INCLUSION CRITERIA (main): Male≥ 18 years with histological confirmation of prostatic adenocarcinoma, Biochemical progression following to RP, PLND and adjuvant or salvage EBRT or following to salvage LND in patients treated formerly by RP and adjuvant or salvage EBRT , No metastases on 68 Ga-PSMA-11 PET/CT and whole body MRI. | ||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Single arm.
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Arms
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Arm title
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Radium-223 arm | ||||||
Arm description |
6 injections with Radium-223 (xofigo) every 4 weeks | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Radium-223
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Investigational medicinal product code |
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Other name |
Xofigo
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
See publication.
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Baseline characteristics reporting groups
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Reporting group title |
Radium-223 arm
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Reporting group description |
6 injections with Radium-223 (xofigo) every 4 weeks | ||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Treated patients
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||
Subject analysis set description |
Patients treated with study drug
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End points reporting groups
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Reporting group title |
Radium-223 arm
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Reporting group description |
6 injections with Radium-223 (xofigo) every 4 weeks | ||
Subject analysis set title |
Treated patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Patients treated with study drug
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End point title |
Safety an tolerability [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
April 2016 to Dec 2020
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: safety and tolerability are reported in the section adverse events. |
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No statistical analyses for this end point |
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End point title |
Time to PSA progression | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
April 2016 to December 2020
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Statistical analysis title |
Time to PSA progression | ||||||||||||
Comparison groups |
Radium-223 arm v Treated patients
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
5.5
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
5.1 | ||||||||||||
upper limit |
7.4 | ||||||||||||
Notes [2] - This is a single arm study with a total of 8 patients included in the analyses. |
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Adverse events information
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Timeframe for reporting adverse events |
April 2016 to December 2020
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Adverse event reporting additional description |
see manuscript
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Radium-223 treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 Sep 2015 |
- Protocol amendement PART 1 and 2
- PI change from Prof. H. Van Poppel to Prof S. Joniau
- IC amended according to different languages
- FOLLOW-UP schedule
- Investigator Brochure
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |