Taking people in ItalyPhase 2
Tests radiation therapy with or without Decapeptyl in prostate cancer
Tests radiation with or without Decapeptyl in adults with prostate cancer.
Key facts
- Who runs it
- Regina Elena Cancer Institute
- Where
- Rome, ItalySee the 2 sites
- Trial code
- Registry title
- Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 146 people, planned
- Started
- 2 Feb 2021
- Expected to end
- 2 Feb 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Decapeptyl
- Record updated
- 28 September 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer of intermediate or high risk that has not spread to lymph nodes or other organs.
- Age
- 18 to 90 years
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma proven by biopsy, intermediate or high risk by the NCCN definition, with no spread to lymph nodes or distant organs (N0M0) on a choline or PSMA PET-CT scan.
- Earlier treatment
- No earlier surgery or cryotherapy of the prostate, no earlier radiotherapy to the pelvis, and no chemotherapy for cancer in the past 5 years.
Main reasons for not taking part
- Earlier surgery or cryotherapy of the prostate
- Earlier radiotherapy to the pelvis
- Chemotherapy for cancer in the past 5 years
- Fiducial markers cannot be implanted, or MRI of the prostate is not possible
- Prostate volume above 90cc
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in Italy
- Ifo Regina ElenaRome, ItalyContact: Giuseppe Sanguineti, ProfessorTaking people
- Regina Elena National Cancer InstituteRome, ItalyContact: giuseppe sanguineti, ProfessorTaking people
About the trial
What the trial wants to find out
This is a prospective, open, randomized phase II trial.
The 2 groups in the trial
- arm 1No study treatment, for comparison
SBRT alone 38 GY in 4 fractions
- arm 2Treatment being tested
SBRT along with short course (6 months) androgen deprivation (STAD)
Treatment: Decapeptyl
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
- Plain-language title
- Tests radiation therapy with or without Decapeptyl in prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05557604, who can take part
- Record updated
- 28 September 2022