Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Princess Margaret Cancer Center
RECRUITING
Toronto
Contact Information
Primary
Rachel Glicksman, MD
rachel.glicksman@uhn.ca
416-946-4501
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2030-06
Participants
Target number of participants: 75
Treatments
Active_comparator: Arm 1 - Standard of Care
Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time.
Experimental: Arm 2 - Experimental
Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov