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

University Health Network, Toronto

Status and phase: Enrolling; Phase 2

Conditions: OligoProgressive Metastatic Disease; Castrate Resistance Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06927635

24-5872

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Arm 1 - Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Systemic therapy

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Arm 2 - Experimental

Experimental group

Description:

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.

Treatment:

Other: Systemic therapy

Radiation: Stereotactic Body Radiation Therapy (SBRT)