Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

NCT06927635 | Recruiting Phase 2

• 1 other identifier: 24-5872
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Castrate Resistance Prostate Cancer; OligoProgressive Metastatic Disease

Keywords

systemic therapy; stereotactic body radiation therapy (SBRT)

Outcome Measures

Primary Outcomes (2)

• Study Feasibility

  Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months).

  Within 18 months of study activation.

• Change in Prostate-Specific Antigen (PSA)

  Assess by standard PSA blood testing if the proportion of patients having a \>50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC.

  Enrollment to 12 months post-enrollment.

Secondary Outcomes (6)

• Radiographic Local Control of Oligopressive Lesions

  Enrollment to 12 months-post enrollment.

• Radiographic Distant Control of Oligopressive Lesions

  Enrollment to 12-months post-enrollment.

• Progression Free Survival (PFS)

  Enrollment to 12-months post-enrollment.

• Time to next Systemic Therapy

  Enrollment to 12-months post-enrollment.

• Differences in Toxicity

  Enrollment to 12-months post-enrollment.

Study Arms (2)

Arm 1 - Standard of Care

ACTIVE COMPARATOR

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Systemic therapy

Arm 2 - Experimental

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.

Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Systemic therapy

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

SBRT will be delivered as per institutional standard.

Arm 1 - Standard of Care; Arm 2 - Experimental

Systemic therapy 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 1 - Standard of Care; Arm 2 - Experimental

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Participants must be male due to the disease site (prostate).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Evidence of spinal cord compression
• Contraindication to radiotherapy

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rachel Glicksman, MD

  Princess Margaret Cancer Centre - University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Glicksman, MD

CONTACT

416-946-4501; rachel.glicksman@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 15, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

CA (1)