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

Study acronym: PATRON
StatusActive, Not Recruiting
PhasePhase 3
Started2021-01-06
View on ClinicalTrials.gov ↗

Amendment history

2025-03-12
Study Status v10
Re-verified, no change to tracked fields
2024-01-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2028-10→2029-01
Completion date2028-10→2029-01
Enrollment targetestimated 776→confirmed 800
Study sites14→19
2022-12-14
Study Status, Sponsor/Collaborators, Contacts/Locations v8
Study sites11→14
Collaborators9 entries, revised
KingstonQueen's Health Sciences CentreUniversity
2021-11-26
Study Status, Contacts/Locations v7
Study sites3→11
2021-11-24
Study Status v6
Re-verified, no change to tracked fields
Show 5 earlier versions
2021-07-20
Study Status v5
Start date2020-01-06→2021-01-06
2021-06-18
Study Status, Contacts/Locations v4
Study sites2→3
2021-03-31
Study Status, Contacts/Locations v3
Study sites1→2
2021-01-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-11→confirmed 2020-01-06
2020-09-21
Study Status, Study Description, Arms and Interventions v1
Study description+22 characters
[...] erapeutic paradigm for patients at risk of advanced cancer. WeInvestigators postulate that intensification of radiotherapy or surgery b [...] overall improvement in quality of life in the longer term. WeInvestigators expect to show that PSMA PET/CT will have a direct and prof [...]
2020-09-18
Original filing
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.
Trial Details
NCT Number NCT04557501
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: 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, Queen's University
Conditions Prostate Cancer
Enrollment 800 participants
Start Date 2021-01-06
Primary Completion 2029-01 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-13