Clinical Trials Register

Summary
EudraCT Number:	2020-004195-17
Sponsor's Protocol Code Number:	STUNNIN
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-05-24
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-004195-17

A.3

Full title of the trial

Sbrt±sTad for Unfavorable iNtermediate rIsk/high risk prostate caNcer (STUNNIN): A Randomized Phase II Study

Sbrt±sTad per il tumore prostatico a rischio intermedio sfavorevole/alto rischio (STUNNIN): studio randomizzato di fase II

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Stereotactic hypofractionated radiotherapy with or without hormonal therapy in prostate cancer patients

Radioterapia stereotassica frazionata con o senza terapia ormonale nei pazienti con tumore alla prostata

A.3.2

Name or abbreviated title of the trial where available

STUNNIN

A.4.1

Sponsor's protocol code number

STUNNIN

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ISTITUTI FISIOTERAPICI OSPITALIERI
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTI FISIOTERAPICI OSPITALIERI
B.5.2	Functional name of contact point	UOC RADIOTERAPIA
B.5.3	Address:
B.5.3.1	Street Address	via Elio Chianesi 53
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00144
B.5.3.4	Country	Italy
B.5.4	Telephone number	0652666125
B.5.6	E-mail	paola.franzoso@ifo.gov.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Enantone 3,75 mg/2ml polvere
D.3.2	Product code	[027066125]
D.3.4	Pharmaceutical form	Powder and solvent for dispersion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEUPROLIDE ACETATO
D.3.9.2	Current sponsor code	027066125
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Decapeptyl
D.3.2	Product code	[026999058]
D.3.4	Pharmaceutical form	Powder and solvent for dispersion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIPTORELINA
D.3.9.2	Current sponsor code	57773-63-4
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	11
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Casodex
D.3.2	Product code	[031113020]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BICALUTAMIDE
D.3.9.2	Current sponsor code	031113020
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Unfavorable intermediate/high risk prostae cancer patients

Pazienti affetti da neoplasia prostatica a rischio intermedio sfavorevole/alto rischio

E.1.1.1

Medical condition in easily understood language

Unfavorable intermediate/high risk prostae cancer patients

Pazienti affetti da neoplasia prostatica a rischio intermedio sfavorevole/alto rischio

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10036946
E.1.2	Term	Prostatic cancer
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.

Sopravvivenza libera da recidiva biochimica (bNED) attuariale 3 anni. Se questa non sarà significativamente differente fra i due bracci sperimentali, quello senza AD verrà selezionato per un futuro confronto con lo standard of care.

E.2.2

Secondary objectives of the trial

Overall survival (OS) at 3 years
- Prostate positive biopsy rates at 2 yrs
- Metastases free survival at 3 yrs
- Cumulative incidence of either GI/GU toxicity at 3 yrs (CTCAE v4.0)
- Nadir PSA at various time points
- Quality of Life at various time points (EORTC QLQ-C30 & FACT-P)
- Erectile function at various time points (IIF-5)
- Urinary Continence at various time points (ICIQ-Sf)
- IPSS at various time points
- Patient satisfaction with treatment at 3 yrs (FACIT-TS-G)

Overall survival (OS) a 3 anni
- Tasso di biopsie prostatiche positive a 2 anni
- Sopravvivenza libera da metastasi a 3 anni
- Incidenza cumulativa sia di tossicità GI/GU a 3 anni (CTCAE v4.0)
- PSA nadir a determinati intervalli di tempo
- Qualità della vita a determinati intervalli di tempo (EORTC QLQ-C30 & FACT-P)
- Funzione erettile a determinati intervalli di tempo (IIF-5)
- Incontinenza urinaria a determinati intervalli di tempo (ICIQ-Sf)
- IPSS a determinati intervalli di tempo
- Soddisfazione del paziente relativa al trattamento a 3 anni (FACIT-TS-G)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Histologically proven prostate adenocarcinoma
- IR or HR in the NCCN definition
- N0M0 at staging with choline or (preferably) PSMA PET-CT;
- ECOG performance status between 0 and 2;

Adenocarcinoma prostatica istologicamente documentato
- Malattia a rischio intermedio o alto rischio secondo la classificazione NCCN
- N0M0 alla stadiazione con PET/TC colina o PET/TC PSMA (preferibilmente)
- ECOG performance status fra 0 e 2

E.4

Principal exclusion criteria

T3b disease according to the 8th AJCC classification;
- PSA>20 ng/ml at any time point
- Gleason Score of 9 or 10 (Grade Grouping V)
- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
- Previous radiotherapy to the pelvis
- Previous chemotherapy for malignancy in past 5 years
- Impossibility to implant fiducials for tracking purposes
- Impossibility to undergo MRI of the prostate - Contraindication to short term AD - Prostate volume >90cc

Malattia T3b secondo 8th AJCC classification;
¿ PSA>20 ng/ml
¿ Gleason Score 9 o 10 (Grade Grouping V)
¿ Precedenti trattamenti locali della prostata (prostatectomia radicale o crioterapia)
¿ Precedente radioterapia sulla pelvi
¿ Pregresso tumore maligno nei 5 anni precedenti
¿ Impossibilità ad impiantare fiducials
¿ Impossibilità ad effettuare RM della prostata ¿ Controindicazioni alla terapia ormonale breve ¿ Volume prostatico >90cc

E.5 End points

E.5.1

Primary end point(s)

The primary objective of the study is 3-yr bNED survival.

Sopravvivenza libera da recidiva biochimica (bNED) attuariale 3 anni.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years after randomization

3 anni dopo la randomizzazione

E.5.2

Secondary end point(s)

Overall survival

Sopravvivenza globale

E.5.2.1

Timepoint(s) of evaluation of this end point

3 years after randomization

3 anni dopo la randomizzazione

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Lo studio vuole valutare l'efficacia della radioterapia con e senza farmaco.

To evaluate radiotherapy with and without drugs

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

146

F.4.2

For a multinational trial

F.4.2.1

In the EEA

146

F.4.2.2

In the whole clinical trial

146

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

According to standard of care

Come da pratica clinica

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-26

P. End of Trial
P.	End of Trial Status	Ongoing

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