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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.

RecruitingNAAges 18 Years - anyMaleCHU de Quebec-Universite Laval
NCT07483658 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 group

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📋 Eligibility rules (as published)
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).
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What it tests

  • Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)
  • Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)
  • Androgen Deprivation Therapy (ADT)
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Where

4 sites
Gatineau Hospital
Gatineau, Canada
Hôpital Général Juif
Montreal, Canada
McGill University Health Centre
Montreal, Canada
CHU de Québec-Université Laval
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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