Overview
Sponsor-declared trial summary
Unfavorable intermediate/high risk prostate cancer patients
the primary objective of the study is 3-year 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.
Key facts
- Sponsor
- I.F.O. Istituti Fisioterapici Ospitalieri
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511886-12-00
- EudraCT number
- 2020-004195-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
the primary objective of the study is 3-year 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.
Secondary objectives 1
- 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)
Conditions and MedDRA coding
Unfavorable intermediate/high risk prostate cancer patients
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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;
Exclusion criteria 1
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective of the study is 3-yr bNED survival.
Secondary endpoints 1
- Overall survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP135589 · ATC
- Active substance
- Bicalutamide
- Substance synonyms
- ICI-176334, (+/-)-4'-CYANO-ALPHA,ALPHA,ALPHA-TRIFLUORO-3-((P-FLUOROPHENYL)SULFONYL)-2-METHYL-M-LACTOTOLUIDIDE
- Route of administration
- BUCCAL USE
- Max daily dose
- 50.00 g gram(s)
- Max total dose
- 50.00 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BB03 — BICALUTAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
I.F.O. Istituti Fisioterapici Ospitalieri
- Sponsor organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Address
- Via Elio Chianesi N 53
- City
- Rome
- Postcode
- 00144
- Country
- Italy
Scientific contact point
- Organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Contact name
- Dott. Massimo Zeuli
Public contact point
- Organisation
- I.F.O. Istituti Fisioterapici Ospitalieri
- Contact name
- Dott. Massimo Zeuli
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 146 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-04-29 | 2024-04-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024_511886_12_00 v2 19Jun2024 CLEAN | 2 |
| Protocol (for publication) | D1_Protocol 2024_511886_12_00 v2_1 05092024 TC | 2.1 |
| Protocol (for publication) | D1_Protocol 2024_511886_12_00 v2_105092024 CLEAN | 2.1 |
| Protocol (for publication) | Prot SBRT per unfav IR HR 15012021 TC vs 1_2 | 2 |
| Recruitment arrangements (for publication) | recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | CI_vers_ultima | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP CASODEX | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ITA 2024_51_1886_1200 CLEAN | 2 |
| Synopsis of the protocol (for publication) | Sinossi STUNNIN_1906620 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Italy | Acceptable 2024-03-28
|
2024-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | Italy | Acceptable 2024-09-23
|
2024-10-25 |