RecruitingPhase 2NCT06927635

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

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


Sponsor

University Health Network, Toronto

Enrollment

75 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria8

  • 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 Criteria2

  • Evidence of spinal cord compression
  • Contraindication to radiotherapy

Interventions

RADIATIONStereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered as per institutional standard.

OTHERSystemic 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.


Locations(1)

Princess Margaret Cancer Center

Toronto, Ontario, Canada

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NCT06927635


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