Clinical trial NCT06927635: Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer
Official title: Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Castrate Resistance Prostate Cancer
OligoProgressive Metastatic Disease
Keywords: systemic therapy
stereotactic body radiation therapy (SBRT)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Feasibility
timeFrame: Within 18 months of study activation.
measure: Change in Prostate-Specific Antigen (PSA)
timeFrame: Enrollment to 12 months post-enrollment.
Secondary outcomes:
measure: Radiographic Local Control of Oligopressive Lesions
timeFrame: Enrollment to 12 months-post enrollment.
measure: Radiographic Distant Control of Oligopressive Lesions
timeFrame: Enrollment to 12-months post-enrollment.
measure: Progression Free Survival (PFS)
timeFrame: Enrollment to 12-months post-enrollment.
measure: Time to next Systemic Therapy
timeFrame: Enrollment to 12-months post-enrollment.
measure: Differences in Toxicity
timeFrame: Enrollment to 12-months post-enrollment.
measure: Differences in Quality of Life
timeFrame: Enrollment to 12-months post-enrollment.
Other outcomes:
Locations:
Study officials:
affiliation: Princess Margaret Cancer Centre - University Health Network
name: Rachel Glicksman, MD
role: PRINCIPAL_INVESTIGATOR
References: