RecruitingNot ApplicableNCT04610372

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

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

Sponsor

British Columbia Cancer Agency

Enrollment

168 participants

Start Date

Jul 12, 2021

Study Type

INTERVENTIONAL

Conditions

Oligometastatic Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called PROMPT) is comparing different radiation therapy approaches for men with newly diagnosed prostate cancer that has spread to a limited number of sites in the body (called oligometastatic disease). It compares a standard radiation schedule with more focused, high-dose radiation treatments. **You may be eligible if...** - You have been confirmed by biopsy to have prostate cancer - Your cancer has spread to a limited number of sites (oligometastatic) - You have not had prior treatment for prostate cancer (other than hormone therapy) - You are healthy enough for radiation treatment and follow-up - You are planned for long-term hormone therapy (more than 9 months) **You may NOT be eligible if...** - You have previously been treated for prostate cancer beyond hormone therapy - You have a high volume of metastases - You have severe urinary problems (very high symptom score) - You cannot complete the required scans and tests before treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated external beam radiotherapy

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

RADIATIONHigh 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

RADIATIONPermanent seed implant

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

RADIATIONStereotactic 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.