Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study
Phase 1
- Conditions
- nfavorable intermediate/high risk prostate cancer patientsTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511886-12-00
- Lead Sponsor
- I.F.O. Istituti Fisioterapici Ospitalieri
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 146
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;
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: 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);Primary end point(s): The primary objective of the study is 3-yr bNED survival.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall survival