Recruiting
Phase 2

SBRT with ST

Sponsor:

University Health Network, Toronto

Code:

NCT06927635

Conditions

Castrate Resistance Prostate Cancer

OligoProgressive Metastatic Disease

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Systemic therapy

Study Details

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

Study ID

NCT06927635

Start date

Jul 8, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Stereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered as per institutional standard.

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.

Primary outcome measure

  • Study Feasibility [ Time Frame: Within 18 months of study activation. ]
  • Change in Prostate-Specific Antigen (PSA) [ Time Frame: Enrollment to 12 months post-enrollment. ]

Central Contacts and Locations

Central contacts

Rachel Glicksman, MD

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

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Rachel Glicksman, MD

416-946-4483rachel.glicksman@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • systemic therapy
  • stereotactic body radiation therapy (SBRT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-07.