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Five sessions instead of twenty-five: could a shorter radiation course transform prostate cancer treatment?

NCT ID NCT04197141

Disease control Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial compares two ways of delivering radiation to the pelvis in men with unfavorable intermediate- or high-risk prostate cancer. One group receives the standard 25 sessions of radiation, while the other receives just 5 sessions with a higher dose per session. The goal is to see if the shorter course is as well tolerated, especially regarding bowel quality of life, and whether it could become a more convenient option. The study also looks at urinary and sexual side effects, as well as early signs of cancer control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiation therapy (hypofractionated whole-pelvis radiotherapy)
What this could lead to
If successful, this could make pelvic radiation for prostate cancer much more convenient, with fewer hospital visits and similar quality of life, potentially becoming a new standard of care.
What could go wrong
This is a small phase 2 trial, so results may not be definitive. The shorter, higher-dose radiation might cause different side effects, and long-term cancer control is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 or older * Study Informed Consent provided * Pathologically proven diagnosis of prostatic adenocarcinoma * Unfavorable intermediate risk \[with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate\] or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification \[Prostatic Specific Antigen (PSA) \> 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10\] * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy Exclusion Criteria: * Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization * Plan for adjuvant docetaxel post-radiotherapy * Serious medical comorbidities or other contraindications to HDR-BT * Presence of inflammatory bowel disease * Presence of connective tissue disease * Medically unfit for general anesthesia * Unable or unwilling to complete questionnaires

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • BC Cancer

    Kelowna, British Columbia, V1Y 5L3, Canada

  • London Regional Cancer Program of the Lawson Health Research Institute

    London, Ontario, N6A 5W9, Canada

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

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