Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04557501
PHASE3

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

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

PSMA PET/CT guided intensification of therapy

PSMA PET/CT prior to treatment.

OTHER

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