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

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.

Conditions

• Prostate Cancer

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

Sponsors & Collaborators

• Canadian Cancer Society (CCS)

  collaborator OTHER

• Lantheus Medical Imaging

  collaborator INDUSTRY

• British Columbia Cancer Agency

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• Princess Margaret Hospital, Canada

  collaborator OTHER

• Tom Baker Cancer Centre

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Institute of Health Economics, Canada

  collaborator OTHER

• Queen's University

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-06

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• Canada

Study Locations