Combining SBRT with short-term androgen deprivation for high-risk prostate cancer
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Rome, Lazio and 2 other locations) |
| Trial ID | NCT05557604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed prostate adenocarcinoma classified as intermediate or high risk, who have not undergone prior local treatment.
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.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar combined treatment approaches in prostate cancer, indicating potential for success.
Eligibility criteria
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 this trial is running
Rome, Lazio and 2 other locations
- Ifo Regina elena — Rome, Lazio, Italy (Recruiting)
- ifo Regina Elena — Rome, Rm, Italy (Recruiting)
- Regina Elena National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Sanguineti, Professor
- Email: giuseppe.sanguineti@ifo.it
- Phone: 0652663015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.