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

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04557501
• Collaborator: Canadian Cancer Society (CCS) (Other), Lantheus Medical Imaging (Industry), British Columbia Cancer Agency (Other), London Health Sciences Centre (Other), Princess Margaret Hospital, Canada (Other), Tom Baker Cancer Centre (Other), McMaster University (Other), Institute of Health Economics, Canada (Other), Kingston Health Sciences Centre (Other)
• Enrollment: 776
• Locations: 11
• Arms: 2
• Anticipated Duration (Months): 92.8
• Patients Per Site: 70.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: PSMA PET/CT guided intensification of therapy; Other: Control Arm	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 776 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer
• Actual Study Start Date: Jan 6, 2021
• Anticipated Primary Completion Date: Oct 1, 2028
• Anticipated Study Completion Date: Oct 1, 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Rates of toxicity (CTCAE) [5 years]

2. Time to subsequent next-line therapy [5 years]

3. Quality of Life (EPIC 26) [5 years]

4. New lesion detection yield (on PSMA PET/CT) [3 years]

5. Impact of PMSA PET/CT on RT or surgical management (rate of treatment intensification) [3 years]

6. Cost-effectiveness (EQ5D5L) [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
2	St-Joseph's Healthcare	Hamilton	Ontario	Canada	L8N 4A6
3	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
4	Grand River Regional Cancer Centre	Kitchener	Ontario	Canada	N2G 1G3
5	Londong Health Sciences Centre	London	Ontario	Canada	N6A 5W9
6	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 1X6
7	Hopital de la Cité de la Santé	Laval	Quebec	Canada	H7M 3L9
8	McGill University Health Center	Montreal	Quebec	Canada	H4A 3J1
9	CHU de Québec	Québec	Quebec	Canada
10	CHUS	Sherbrooke	Quebec	Canada	J1H 5H3
11	CHUM	Montréal		Canada

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT04557501
• Other Study ID Numbers: 20.208
• First Posted: Sep 21, 2020
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Nov 30, 2021