Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Stereotactic Body Radiation Therapy (SBRT): SBRT will be delivered as per institutional standard.

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.

Study 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

Primary outcome measure(s)

• Study Feasibility — Within 18 months of study activation.
  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).
• Change in Prostate-Specific Antigen (PSA) — Enrollment to 12 months post-enrollment.
  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.

Trial sites (1)

More University Health Network, Toronto trials in Canada

Other trials for the same condition