Shorter Salvage Radiotherapy after Prostate Surgery for Recurrent Prostate Cancer

Is this trial a fit for you?

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

What this trial studies

This interventional study compares two post-operative salvage radiotherapy regimens for locally recurrent prostate cancer after radical prostatectomy. Arm A uses standard fractionation of 25 sessions (approximately 5 weeks) to the prostate bed and pelvis, with possible addition of hormone therapy. Arm B uses a hypofractionated schedule of 20 sessions (about 4 weeks) to the same targets, with the option of concurrent hormone therapy. The trial includes men with detectable PSA, no distant metastasis, and adequate organ function, and excludes those with prior pelvic radiotherapy or active inflammatory GI disease. Primary aim is to determine if the shorter course is non-inferior in safety and effectiveness compared with the standard course.

Why it matters

Who can join: the full rules

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).

Where it's running

• CHU de Québec-Université Laval
  Québec, Quebec, Canada Recruiting
• Gatineau Hospital
  Gatineau, Quebec, Canada Not yet recruiting
• Hôpital Général Juif
  Montreal, Quebec, Canada Not yet recruiting
• McGill University Health Centre
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Eric Vigneault, MD, MSc — CHU de Québec-Université Laval
• Study coordinator: Eric Vigneault, MD, MSc
• Email: eric.vigneault.med@ssss.gouv.qc.ca
• Phone: 418 691-5264

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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.