Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

NCT ID: NCT06927635

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2030-06-30

Brief 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).

Detailed Description

The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.

Conditions

Castrate Resistance Prostate Cancer; OligoProgressive Metastatic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

SBRT will be delivered as per institutional standard.

Systemic therapy

Intervention Type: OTHER

Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

SBRT will be delivered as per institutional standard.

Systemic therapy

Intervention Type: OTHER

Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered as per institutional standard.

Intervention Type: RADIATION

Systemic therapy

Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Evidence of spinal cord compression
• Contraindication to radiotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Glicksman, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre - University Health Network

Locations

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Rachel Glicksman, MD

Role: CONTACT

rachel.glicksman@uhn.ca

416-946-4501 ext. 4961

Facility Contacts

Rachel Glicksman, MD

Role: primary

rachel.glicksman@rmp.uhn.ca

416-946-4483

Other Identifiers

24-5872

Identifier Type: -

Identifier Source: org_study_id