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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Control Arm; Diagnostic test: PSMA PET/CT guided intensification of therapy

Detailed Description

PSMA PET/CT, particularly with the new generation [18F]DCFPyL radiotracer, has substantially improved our ability to detect sites of prostate cancer compared with conventional imaging alone. When combined with innovative radiotherapeutic and surgical techniques that can now safely target and ablate such disease sites, next generation imaging is now poised to transform the therapeutic paradigm for patients at risk of advanced cancer.

Investigators postulate that intensification of radiotherapy or surgery based on the results of PSMA PET/CT will improve cancer control outcomes in a cost-effective manner, with minimal toxicity, and an overall improvement in quality of life in the longer term.

Investigators expect to show that PSMA PET/CT will have a direct and profound impact on radiotherapy and surgery practice, translating to improved failure-free survival outcomes in patients at risk of advanced prostate cancer. The subset of patients potentially impacted is broad, including patients recurring after prostatectomy and newly presenting patients with high-risk features. Although PSMA PET/CT is increasingly making its way into clinical practice around the world, Canadian provinces will need to make an informed decision of whether to fund this imaging for our patients. The high-level evidence gathered in this trial is desperately needed to assess the impact on patient outcomes and, in doing so, justify broad access and reimbursement for patients with prostate cancer.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Calgary, Canada
    • Tom Baker Cancer Center
  • Edmonton, Canada
    • Cross Cancer Institute
  • Montreal, Canada
    • Jewish General Hospital
  • Montréal, Canada
    • CHUM
  • Windsor, Canada
    • Windsor Regional Cancer Centre
  • Winnipeg, Canada
    • Cancer Care Manitoba
  • British Columbia
    • Kelowna, British Columbia, Canada
      • BC Cancer Kelowna
    • Vancouver, British Columbia, Canada
      • BC Cancer Vancouver
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • Hamilton, Ontario, Canada, L8N 4A6
      • St-Joseph's Healthcare
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Regional Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 1X6
      • Princess Margaret Cancer Centre
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Hôpital de la Cité de la Santé
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Center
    • Montreal, Quebec, Canada, H2X 3H7
      • Charles LeMoyne Hospital
    • Québec, Quebec, Canada
      • CHU de Québec
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histological diagnosis of adenocarcinoma of the prostate planned for curative-intent standard-of-care radiotherapy (primary or salvage post prostatectomy) or radical prostatectomy with lymph node dissection.
• Age ≥ 18
• High risk of regional or distant metastases as defined by any of:
• Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.
• Prior history of radical prostatectomy and biochemical failure (PSA>0.1ng/mL).
• Patients must provide study-specific informed consent prior to study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

• Active or prior androgen deprivation therapy (except 5-alpha reductase inhibitor) terminated < 12 months prior to enrollment.
• Prior or planned PSMA PET/CT scan outside of this clinical trial.
• Charlson Comorbidity Index > 5 (see Appendix 2).
• Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)
• Evidence of extra-pelvic nodal disease (M1a) on conventional imaging (if performed)
• Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - SOC Treatment; Participants to receive surgery or radiotherapy (+/- hormone therapy) as planned per SOC.	Other: Control Arm; Control - Treatment without PSMA PET/CT
Experimental: Experimental - PSMAiTx; Participants undergo PSMA PET/CT prior to treatment, and treated intensified based on image findings.	Diagnostic test: PSMA PET/CT guided intensification of therapy; PSMA PET/CT prior to treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if PSMA PET/CT guided intensification of therapy is superior to standard of care (SOC) therapy as measured by improved failure-free survival (FFS).	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of toxicity (CTCAE)	5 years
Time to subsequent next-line therapy	5 years
Quality of Life (EPIC 26)	5 years
New lesion detection yield (on PSMA PET/CT)	3 years
Impact of PMSA PET/CT on RT or surgical management (rate of treatment intensification)	3 years
Cost-effectiveness (EQ5D5L)	5 years

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: McMaster University; London Health Sciences Centre; Canadian Cancer Society (CCS); Princess Margaret Hospital, Canada; British Columbia Cancer Agency; Institute of Health Economics, Canada; Tom Baker Cancer Centre; Lantheus Medical Imaging; Kingston Health Sciences Centre

Publications and helpful links

General Publications

• Menard C, Young S, Zukotynski K, Hamilton RJ, Benard F, Yip S, McCabe C, Saad F, Brundage M, Nitulescu R, Bauman G. PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial. BMC Cancer. 2022 Mar 8;22(1):251. doi: 10.1186/s12885-022-09283-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20.208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No