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Clinical trial Recruiting at 3 sites Phase 2 Interventional Ages 18 to 90 Men only

Combining SBRT with short-term androgen deprivation for high-risk prostate cancer

Official title: Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study

Run by Regina Elena Cancer Institute · NCT05557604 · Data updated 2026-11-12

This study is testing whether adding a short-term hormone treatment to a type of targeted radiation can help men with high-risk prostate cancer do better than just using radiation alone.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 90 Years
SexMen only
Enrollment146 (estimated)
SponsorRegina Elena Cancer Institute
Academic / other
Drugs / interventionschemotherapy
Locations3 sites (Rome, Lazio and 2 other locations)
StatusRecruiting
StartedFebruary 2, 2021
Main results expectedFebruary 2, 2024
Study endsFebruary 2, 2027
Registry record updatedSeptember 28, 2022
Trial IDNCT05557604 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with histologically confirmed prostate adenocarcinoma classified as intermediate or high risk, who have not undergone prior local treatment.

Probably not a fit

Patients with previous prostate surgery, radiotherapy, or chemotherapy, or those unable to undergo necessary imaging or treatment procedures, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of stereotactic body radiotherapy (SBRT) alone versus SBRT combined with a short course of androgen deprivation therapy in patients with unfavorable intermediate to high-risk prostate cancer. Patients will be randomly assigned to receive either treatment, with all participants undergoing intensity-modulated radiotherapy. The study aims to determine if the addition of androgen deprivation enhances treatment outcomes compared to SBRT alone.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk prostate cancer.

How similar studies have gone: Other studies have shown promising results with similar combined treatment approaches in prostate cancer, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Ifo Regina elena
    Rome, Lazio, Italy     Recruiting
  • ifo Regina Elena
    Rome, Rm, Italy     Recruiting
  • Regina Elena National Cancer Institute
    Rome, Italy     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464Regina Elena Cancer Institute 29
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.