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

NCT04557501 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: 20.208
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Control - SOC Treatment

ACTIVE COMPARATOR

Participants to receive surgery or radiotherapy (+/- hormone therapy) as planned per SOC.

Other: Control Arm

Experimental - PSMAiTx

EXPERIMENTAL

Participants undergo PSMA PET/CT prior to treatment, and treated intensified based on image findings.

Diagnostic Test: PSMA PET/CT guided intensification of therapy

Interventions

PSMA PET/CT guided intensification of therapy DIAGNOSTIC_TEST

PSMA PET/CT prior to treatment.

Experimental - PSMAiTx

Control Arm OTHER

Control - Treatment without PSMA PET/CT

Control - SOC Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (19)

BC Cancer Kelowna

Kelowna, British Columbia, Canada

Location

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

St-Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X6, Canada

Location

Hopital de la Cité de la Santé

Laval, Quebec, H7M 3L9, Canada

Location

Charles Lemoyne Hospital

Montreal, Quebec, H2X 3H7, Canada

Location

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Québec

Québec, Quebec, Canada

Location

CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Tom Baker Cancer Center

Calgary, Canada

Location

Cross Cancer Institute

Edmonton, Canada

Location

CHUM

Montreal, Canada

Location

Jewish General Hospital

Montreal, Canada

Location

Windsor Regional Cancer Centre

Windsor, Canada

Location

Cancer Care Manitoba

Winnipeg, Canada

Location

Related Publications (1)

• 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.

  PMID: 35260100 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: January 6, 2021
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (19)