Clinical trial · Interventional
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
NCT05557604CI-TRIAL-00061076STUNNINrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, open, randomized phase II trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decapeptyl | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- arm 1
- description
- SBRT alone 38 GY in 4 fractions
- type
- EXPERIMENTAL
- label
- arm 2
- description
- SBRT along with short course (6 months) androgen deprivation (STAD)
- interventionNames
- Drug: Decapeptyl
Primary outcomes (1)
- measure
- 3-yr bNED survival
- timeFrame
- 3 years
- description
- The primary objective of the study is 3-yr 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.