Actively Recruiting
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
Led by University Health Network, Toronto · Updated on 2025-09-05
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach for men with Oligopressive Castrate Resistance Prostate Cancer (CRPC), a type of advanced prostate cancer with limited spread. This randomized Phase II trial compares whether using Stereotactic Body Radiotherapy (SBRT) on all sites of limited disease while continuing current systemic therapy can improve biochemical control compared to the standard care, which usually involves changing systemic therapy. The study aims to maintain quality of life while managing the cancer and avoiding toxic side effects from changing treatments. Participants are randomly assigned to one of two groups. One group receives the standard care, where their systemic therapy may be changed based on their oncologist's decision and usual clinical practices, including supportive care and palliative radiotherapy if needed. The other group continues their current systemic therapy without changes and receives SBRT targeting all oligoprogressive disease sites according to institutional standards. The SBRT is delivered following established protocols to focus radiation precisely on cancer sites. During the study, participants will be monitored for up to 12 months after enrollment to assess study feasibility and changes in prostate-specific antigen (PSA) levels. Researchers will also evaluate radiographic control of cancer at treated and distant sites, progression-free survival, time to next systemic therapy, differences in treatment-related side effects, and quality of life. The total participation period includes up to 18 months to assess feasibility, with regular assessments throughout to track treatment effects and safety.
CONDITIONS
Brief Title
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- Castrate Resistance Prostate Cancer
- Radiographic evidence of fewer than 10 sites of extra-cranial oligopressive metastatic lesions
- Receiving any line of systemic therapy for more than 3 months
- All sites of oligopressive disease are amenable to and can be safely treated with SBRT
- ECOG performance status between 0 and 3
You will not qualify if you...
- Evidence of spinal cord compression
- Contraindication to radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either standard systemic therapy with possible changes over time or stereotactic body radiotherapy (SBRT) to oligopressive sites while continuing their current systemic therapy.
Regular visits as per institutional standards during treatment
Duration - Up to 12 months after treatment
Participants are monitored for changes in prostate-specific antigen (PSA), radiographic control of lesions, progression-free survival, toxicity, and quality of life for up to 12 months post enrollment.
Visits as scheduled for assessments up to 12 months post enrollment
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
R
Rachel Glicksman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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