RecruitingNot Applicable

Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer

Canada100 participantsStarted 2022-07-18

Plain-language summary

This is a single-arm phase II prospective trials that is recruiting 100 participants. The study population that is being investigated are patients with localized high-risk or node-positive prostate cancer. Participants will receive external beam radiotherapy as a moderately hypofractionated boost to the prostate with pelvic radiation therapy. Androgen deprivation therapy will be prescribed at the discretion of the treating physician as per standard of care.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years. * Able to provide informed consent. * Histologic diagnosis of prostate adenocarcinoma. * ECOG performance status 0-1. * High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease. * Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET)) Exclusion Criteria: * Prior pelvic radiotherapy. * Contraindications to radiotherapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute Grade >2 Gastrointestinal Toxicity

Timeframe: Baseline to 5-year follow-up

Trial details

NCT IDNCT05313815

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04

Contact for this trial

Rachel Glicksman, MD

416-946-4486 rachel.glicksman@rmp.uhn.ca

View on ClinicalTrials.gov More Prostate Cancer trials