Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study
Key facts
- Where
- Milan, Rome és Trieste, OlaszországSee the 3 sites
- Phase
- 2. fázis
Where in Olaszország
- San Raffaele HospitalMilan, OlaszországTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, OlaszországTaking people
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- I.F.O. Istituti Fisioterapici Ospitalieri
- Trial code
- EU 2024-511886-12-00
- Record updated
- 2026. július 13.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.