Radiation treatment comparison for metastatic prostate cancer
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
This study is testing whether getting radiation treatment every other day for two weeks causes different side effects compared to getting it once a week for six weeks in men with metastatic prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05656794 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the side effects of two different radiation treatment schedules for patients with metastatic prostate cancer. Participants will receive radiation either every other day for two weeks or once weekly for six weeks. The study aims to determine if the frequency of treatment affects the side effects experienced by patients. It is a randomized trial, meaning participants will be assigned to one of the two treatment groups by chance.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically-proven metastatic prostate cancer and specific criteria regarding the volume and location of metastases.
Not a fit: Patients with prior pelvic radiotherapy or conditions that contraindicate radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize radiation treatment schedules to minimize side effects for patients with metastatic prostate cancer.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown varying results in optimizing radiation schedules for cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- University Health Network, Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Peter Chung, MD
- Email: peter.chung@rmp.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.