NCT05656794 Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
| NCT ID | NCT05656794 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Prostate Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2031-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.
Eligibility Criteria
Inclusion Criteria: * Histologically-proven prostate cancer * Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.) * Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.) * Planned for EBRT * ECOG 0 or 1 * Age 18 years or older Exclusion Criteria: * Prior radiotherapy to pelvis * Active ulcerative colitis or Crohn's Disease, at discretion of treating physician * Any condition where radiotherapy is contraindicated