PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer (NCT04557501)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: BC Cancer Kelowna — Kelowna, British Columbia
Age range: 18 Years
🧪 Interventions in This Study
- PSMA PET/CT guided intensification of therapy (DIAGNOSTIC_TEST)
- Control Arm (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- BC Cancer Kelowna — Kelowna, British Columbia
- BC Cancer Vancouver — Vancouver, British Columbia
- Royal Victoria Regional Health Centre — Barrie, Ontario
- St-Joseph's Healthcare — Hamilton, Ontario
- Juravinski Cancer Centre — Hamilton, Ontario
- Grand River Regional Cancer Centre — Kitchener, Ontario
- London Health Sciences Centre — London, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario
- Hopital de la Cité de la Santé — Laval, Quebec
- Charles Lemoyne Hospital — Montreal, Quebec
- McGill University Health Center — Montreal, Quebec
- CHU de Québec — Québec, Quebec
- CHUS — Sherbrooke, Quebec
- Tom Baker Cancer Center — Calgary,
- Cross Cancer Institute — Edmonton,
- CHUM — Montreal,
- Jewish General Hospital — Montreal,
- Windsor Regional Cancer Centre — Windsor,
- Cancer Care Manitoba — Winnipeg,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.