RecruitingPhase 2NCT05557604
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
Sponsor
Regina Elena Cancer Institute
Enrollment
146 participants
Start Date
Feb 2, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This is a prospective, open, randomized phase II trial.
Eligibility
Sex: MALEMin Age: 18 YearsMax Age: 90 Years
Inclusion Criteria4
- 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 Criteria7
- 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
Interventions
DRUGDecapeptyl
STAD androgen deprivation
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05557604
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