Clinical Trial

PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer

Study acronym: PATRON
Active, Not Recruiting Phase 3
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Summary
Through the conduct of a Phase III randomized controlled trial, investigators plan to: 1) determine if PSMA PET/CT guided intensification of radiotherapy or surgery improves cancer outcomes compared to conventional imaging-guided therapy in patients at risk of advanced disease, 2) evaluate its impact on toxicity and quality of life, and 3) measure the cost-effectiveness of the PSMA PET/CT guided approach. Participants with high-risk prostate cancer planned for curative-intent standard-of-care radiotherapy or surgery, or with biochemical failure after radical prostatectomy planned for salvage radiotherapy will be enrolled over 3 years (n=776). Those randomized to the investigational arm will have PSMA PET/CT prior to therapy. Based on the imaging results, treating physicians will intensify radiotherapy or surgery unless widely metastatic disease is found, in which case systemic therapy will be intensified.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-09-18; most recent amendment 2025-03-12.
Status change: Recruiting → Active, Not Recruiting 2024-01-10
Status change: Not Yet Recruiting → Recruiting 2021-01-06
Trial Details
NCT Number NCT04557501
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Canadian Cancer Society (CCS), Lantheus Medical Imaging, British Columbia Cancer Agency, London Health Sciences Centre, Princess Margaret Hospital, Canada, Tom Baker Cancer Centre, McMaster University, Institute of Health Economics, Canada, Queen's University
Conditions Prostate Cancer
Enrollment 800 participants
Start Date 2021-01-06
Primary Completion 2029-01 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-13