NCT07483658Recruiting
Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.
Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule. Why is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe. What is being compared? Standard treatment (Arm A): 25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy Shorter treatment (Arm B): 20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy Both groups may also receive hormone therapy (ADT) for 6-24 months. Main Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar. Other Things to be Measured Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires) Who can join? Men who: Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2) How long will the study last? About 12 years total: 2 years to enroll patients 10 years of follow-up
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 434 (estimated)
- First submitted
- 13 Mar 2026
- Start date
- 13 May 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- CHU de Quebec-Universite Laval
- Diseases
- Prostate cancer
- NCT number
- NCT07483658
What you commit to
- Study type: Interventional
- Planned participants: 434
- From 13 May 2026 to the primary completion date, Dec 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy.
- Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).
Other illness
- Presence of metastatic disease.
- Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
Other
- Macroscopic local relapse on imaging
- Uncontrolled comorbidities affecting study participation.
Who the study is looking for
- Histologically confirmed prostate adenocarcinoma.
- Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).
- No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).
- Patient with Nodal recurrence within the pelvis are eligible
- ECOG performance status 0-2.
- Age ≥ 18 years.
- Adequate baseline renal, hepatic, and hematologic function.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gatineau Hospital Coordinator of this site? Confirm its status | Gatineau | Canada | Not yet recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Hôpital Général Juif Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| CHU de Quebec-Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.