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Recruiting NCT06927635

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

Phase II Interventional Castrate Resistance Prostate Cancer OligoProgressive Metastatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic Body Radiation Therapy (SBRT), Systemic therapy.
Who it may be relevant to
Registry conditions: Castrate Resistance Prostate Cancer, OligoProgressive Metastatic Disease. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

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.

Interventions

  • 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.

Primary outcome measures

  • Study Feasibility [Time frame: Within 18 months of study activation.]
  • Change in Prostate-Specific Antigen (PSA) [Time frame: Enrollment to 12 months post-enrollment.]
Secondary outcome measures (6)
  • Radiographic Local Control of Oligopressive Lesions [Time frame: Enrollment to 12 months-post enrollment.]
  • Radiographic Distant Control of Oligopressive Lesions [Time frame: Enrollment to 12-months post-enrollment.]
  • Progression Free Survival (PFS) [Time frame: Enrollment to 12-months post-enrollment.]
  • Time to next Systemic Therapy [Time frame: Enrollment to 12-months post-enrollment.]
  • Differences in Toxicity [Time frame: Enrollment to 12-months post-enrollment.]
  • Differences in Quality of Life [Time frame: Enrollment to 12-months post-enrollment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT06927635 · 24-5872

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗