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PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2021-01-06
Completion Date
2029-01
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
PSMA PET/CT guided intensification of therapy
PSMA PET/CT prior to treatment.
Control Arm
Control - Treatment without PSMA PET/CT
Locations (19)
BC Cancer Kelowna
Kelowna, British Columbia, Canada
BC Cancer Vancouver
Vancouver, British Columbia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
St-Joseph's Healthcare
Hamilton, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hopital de la Cité de la Santé
Laval, Quebec, Canada
Charles Lemoyne Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
CHU de Québec
Québec, Quebec, Canada
CHUS
Sherbrooke, Quebec, Canada
Tom Baker Cancer Center
Calgary, Canada
Cross Cancer Institute
Edmonton, Canada
CHUM
Montreal, Canada
Jewish General Hospital
Montreal, Canada
Windsor Regional Cancer Centre
Windsor, Canada
Cancer Care Manitoba
Winnipeg, Canada