Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer (SECURE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Castrate Resistance Prostate Cancer; OligoProgressive Metastatic Disease
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT); Other: Systemic therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachel Glicksman, MD; Phone Number: 4961 416-946-4501; Email: rachel.glicksman@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Center
      • Contact: Rachel Glicksman, MD; Phone Number: 416-946-4483; Email: rachel.glicksman@rmp.uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Radiation: Stereotactic Body Radiation Therapy (SBRT); SBRT will be delivered as per institutional standard.; Other: 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.
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.	Radiation: Stereotactic Body Radiation Therapy (SBRT); SBRT will be delivered as per institutional standard.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Local Control of Oligopressive Lesions	Radiographic local control of the index OP lesions will be assessed by treating oncologist.	Enrollment to 12 months-post enrollment.
Radiographic Distant Control of Oligopressive Lesions	Defined by growth of non-Oligoprogressive metastatic sites and/or the development of new sites of metastatic disease, as assessed by treating oncologist.	Enrollment to 12-months post-enrollment.
Progression Free Survival (PFS)	Defined as the time from randomization to death from any cause, progression of disease, or date of last follow-up, whichever occurs first. PFS will be assessed by the treating oncologist.	Enrollment to 12-months post-enrollment.
Time to next Systemic Therapy	Defined as the time from when the study intervention has been commenced until commencement of any next systemic anti-cancer therapy (including a change to best supportive care) or date of last follow up, whichever occurs first, which will be assess by the treating oncologist.	Enrollment to 12-months post-enrollment.
Differences in Toxicity	Toxicity will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported toxicity differences. Toxicity will be collected using CTCAE v5.0	Enrollment to 12-months post-enrollment.
Differences in Quality of Life	Quality of Life (QoL) will be assessed to determine whether SBRT compared to SoC results in patient- and/or physician-reported QoL differences. QoL will be collected using the EORTC QLQ-C30 questionnaire.	Enrollment to 12-months post-enrollment.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Rachel Glicksman, MD, Princess Margaret Cancer Centre - University Health Network

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: systemic therapy; stereotactic body radiation therapy (SBRT)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery
• Other Study ID Numbers: 24-5872

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No