Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

Phase 2RecruitingNCT06927635

University Health Network, Toronto75 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Castrate Resistance Prostate Cancer OligoProgressive Metastatic Disease

Interventions

Stereotactic Body Radiation Therapy (SBRT)RADIATION

SBRT will be delivered as per institutional standard.

Systemic therapyOTHER

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Enrollment to 12 months post-enrollment.

Secondary Outcomes

Radiographic Local Control of Oligopressive Lesions

Radiographic local control of the index OP lesions will be assessed by treating oncologist.

Time frame: 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.