2024-511886-12-00RecruitingPhase 2
Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 146 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 29 Apr 2024
- Lead sponsor
- I.F.O. Istituti Fisioterapici Ospitalieri
- Diseases
- Prostate cancer
- EU CT number
- 2024-511886-12-00
- EudraCT number
- 2020-004195-17
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 146
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Hospital | Milan | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri | Rome | Italy | Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.