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

Prostate Cancer Clinical Trial

— PATRON  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04557501
• Other study ID #: 20.208
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 6, 2021
• Est. completion date: January 2029

Study information

• Verified date: January 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Country	Name	City	State
Canada	Royal Victoria Regional Health Centre	Barrie	Ontario
Canada	Tom Baker Cancer Center	Calgary
Canada	Cross Cancer Institute	Edmonton
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St-Joseph's Healthcare	Hamilton	Ontario
Canada	BC Cancer Kelowna	Kelowna	British Columbia
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	Hopital de la Cité de la Santé	Laval	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	Charles Lemoyne Hospital	Montreal	Quebec
Canada	Jewish General Hospital	Montreal
Canada	McGill University Health Center	Montreal	Quebec
Canada	CHUM	Montréal
Canada	CHU de Québec	Québec	Quebec
Canada	CHUS	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer Vancouver	Vancouver	British Columbia
Canada	Windsor Regional Cancer Centre	Windsor
Canada	Cancer Care Manitoba	Winnipeg

Sponsors (10)

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

Country where clinical trial is conducted

Canada, 

Outcome

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