RecruitingPhase 2NCT05656794
Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
Sponsor
University Health Network, Toronto
Enrollment
40 participants
Start Date
Aug 9, 2023
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 YearsMax Age: 100 Years
Inclusion Criteria6
- 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 Criteria3
- Prior radiotherapy to pelvis
- Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
- Any condition where radiotherapy is contraindicated
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Interventions
RADIATIONRadiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05656794