Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
University Health Network, Princess Margaret Hospital
RECRUITING
Toronto
Contact Information
Primary
Peter Chung, MD
peter.chung@rmp.uhn.ca
416-946-4501
Time Frame
Start Date: 2023-08-09
Estimated Completion Date: 2031-08
Participants
Target number of participants: 40
Treatments
Experimental: Arm 1 - Investigational
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Other: Arm 2 - Standard
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: TerSera Therapeutics LLC
Leads: University Health Network, Toronto