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RECRUITING
NCT04610372
NA

5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Sponsor: British Columbia Cancer Agency

View on ClinicalTrials.gov

Summary

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Official title: Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

168

Start Date

2021-07-12

Completion Date

2033-06-30

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

RADIATION

Hypofractionated external beam radiotherapy

5500 cGy/20 fractions delivered 5 days per week over 4 weeks

RADIATION

High dose rate brachytherapy

A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance

RADIATION

Permanent seed implant

Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance

RADIATION

Stereotactic body radiotherapy

External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks.

Locations (4)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, Canada

Fraser Valley Cancer Center

Surrey, British Columbia, Canada

Vancouver Cancer Center

Vancouver, British Columbia, Canada

Vancouver Island Cancer Center

Victoria, British Columbia, Canada