NCT07483658 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.
| NCT ID | NCT07483658 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Reccurent/Metastatic Solid Tumor Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 434 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 434 participants in total. It began in 2026-05-13 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Prior pelvic radiotherapy. * Macroscopic local relapse on imaging * Presence of metastatic disease. * Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity. * Uncontrolled comorbidities affecting study participation. * Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).
Contact & Investigator
Eric Vigneault, MD, MSc
PRINCIPAL INVESTIGATOR
CHU de Québec-Université Laval
Frequently Asked Questions
Who can join the NCT07483658 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Reccurent/Metastatic Solid Tumor Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07483658 currently recruiting?
Yes, NCT07483658 is actively recruiting participants. Contact the research team at eric.vigneault.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT07483658 trial being conducted?
This trial is being conducted at Gatineau, Canada, Montreal, Canada, Montreal, Canada, Québec, Canada.
Who is sponsoring the NCT07483658 clinical trial?
NCT07483658 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Eric Vigneault, MD, MSc at CHU de Québec-Université Laval. The trial plans to enroll 434 participants.