Stereotactic body radiation versus changing systemic therapy for oligoprogressive castrate-resistant prostate cancer
Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
PHASE2 · University Health Network, Toronto · NCT06927635
This will try stereotactic body radiotherapy (SBRT) to all oligoprogressive spots while patients stay on their current systemic therapy to see if that controls disease better than switching systemic therapy in men with castration-resistant oligoprogressive prostate cancer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06927635 on ClinicalTrials.gov |
What this trial studies
This is a single-centre, randomized Phase II two-arm study comparing SBRT to all oligoprogressive extracranial sites while patients remain on their current systemic therapy versus standard of care which involves changing systemic therapy. Eligible patients have castration-resistant prostate cancer with fewer than 10 extracranial oligoprogressive metastatic lesions that can be safely treated with SBRT and have been on the same systemic therapy for more than three months. The trial measures biochemical control (e.g., PSA changes) and monitors quality of life and treatment-related toxicities during follow-up. The goal is to determine whether metastasis-directed SBRT can prolong disease control and delay the need for switching systemic therapy.
Who should consider this trial
Good fit: Adults with histologically confirmed prostate adenocarcinoma who have castrate-resistant disease, fewer than 10 extracranial oligoprogressive lesions amenable to SBRT, have been on their current systemic therapy for more than three months, and have ECOG performance status 0–3.
Not a fit: Patients with widespread (>10) metastases, lesions not suitable for safe SBRT, spinal cord compression, contraindications to radiotherapy, or rapidly progressive disease are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could prolong biochemical disease control and delay switching systemic therapies, potentially preserving quality of life and avoiding additional systemic toxicities.
How similar studies have performed: Metastasis-directed SBRT in oligometastatic prostate cancer has shown promise in trials like STOMP and ORIOLE by delaying progression, but applying SBRT specifically to oligoprogressive castration-resistant disease is less well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Able to provide informed consent * Histologic diagnosis of prostate adenocarcinoma * Castrate Resistance Prostate Cancer * Radiographic evidence of \<10 sites of extra-cranial OP metastatic lesions * Receiving any line of ST for \>3 months * All sites of OP disease are amenable to and can be safely treated with SBRT * ECOG performance status 0-3 Exclusion Criteria: * Evidence of spinal cord compression * Contraindication to radiotherapy
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Rachel Glicksman, MD — Princess Margaret Cancer Centre - University Health Network
- Study coordinator: Rachel Glicksman, MD
- Email: rachel.glicksman@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Castrate Resistance Prostate Cancer, OligoProgressive Metastatic Disease, systemic therapy, stereotactic body radiation therapy