Prostate Cancer Clinical Trial
— PATRONOfficial title:
PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer
Verified date | January 2024 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
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 |
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 |
Canada,
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 |
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