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New study tests if fewer radiation sessions can match standard prostate cancer treatment

NCT ID NCT06235697

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing whether a shorter, more intense radiation treatment called SBRT works as well as the current standard of external radiation plus a brachytherapy boost for men with unfavorable-risk prostate cancer. About 710 participants will also receive hormone therapy. The main goal is to see if SBRT can keep cancer from progressing while being more convenient.

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 (Stereotactic Body Radiation Therapy or SBRT) and androgen deprivation therapy (hormone therapy)
What this could lead to
If SBRT works as well as the standard approach, men with prostate cancer could get effective treatment in fewer sessions, making care more convenient and less invasive.
What could go wrong
This is a large phase 3 trial, but it's still testing whether SBRT is truly as good as the standard. There's a chance SBRT may not control the cancer as well, and side effects from radiation or hormone therapy remain possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 710 people

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

Started

Apr 2024

Expected to finish

Apr 2033

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months * Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022): • Unfavourable-intermediate risk - has one or more of the following: * 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml; * Gleason 4+3 (grade group 3) * \> 50% biopsy cores positive • High risk - has one of the following: * cT3a * Gleason 8-10 (grade group 4 or 5) * PSA \> 20 ng/ml • Very-high risk - has at least one of the following: * cT3b-cT4 * Primary Gleason pattern 5 * 2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA \> 20 ng/ml * \> 4 cores with Gleason 8-10 (grade group 4 or 5) * ECOG performance status of 0, 1 or 2 * Participants must be ≥ 18 years of age * Judged to be medically fit for brachytherapy * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish * Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up * In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment * Participants must be willing to take precautions to prevent pregnancy while on study * ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment * 5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment * Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Urinary function defined as International Prostate Symptom Score (IPSS) \< 20. Alpha blockers are allowed to treat baseline urinary function * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial Exclusion Criteria: * Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease) * Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis * Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy) * Prostate volume \> 60cc before start of androgen deprivation therapy * Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe) * Evidence of castrate resistance (defined as a rising PSA \> 3.0 ng/ml while testosterone is \< 3.0 nmol/l) * Hip prosthesis (unilateral hip replacement is allowed if dose constrains can be reasonably achieved.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    57 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Bon Secours Cancer Institute at Reynolds Crossing

    RECRUITING

    Richmond, Virginia, 23230, United States

  • Bon Secours Saint Francis Medical Center

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • CHUM - Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Doctor H. Bliss Murphy Cancer Centre

    RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Forbes Hospital

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Jefferson Hospital

    RECRUITING

    Jefferson Hills, Pennsylvania, 15025, United States

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Kaiser Permanente Cancer Treatment Center

    RECRUITING

    South San Francisco, California, 94080, United States

  • Kaiser Permanente Downtown Commons

    RECRUITING

    Sacramento, California, 95814, United States

  • Kaiser Permanente Dublin

    RECRUITING

    Dublin, California, 94568, United States

  • Kaiser Permanente Fresno Orchard Plaza

    RECRUITING

    Fresno, California, 93720, United States

  • Kaiser Permanente Medical Center - Santa Clara

    RECRUITING

    Santa Clara, California, 95051, United States

  • Kaiser Permanente Medical Center-Vacaville

    RECRUITING

    Vacaville, California, 95688, United States

  • Kaiser Permanente Oakland-Broadway

    RECRUITING

    Oakland, California, 94611, United States

  • Kaiser Permanente San Leandro

    RECRUITING

    San Leandro, California, 94577, United States

  • Kaiser Permanente- Marshall Medical Offices

    RECRUITING

    Redwood City, California, 94063, United States

  • Kaiser Permanente-Deer Valley Medical Center

    RECRUITING

    Antioch, California, 94531, United States

  • Kaiser Permanente-Fremont

    RECRUITING

    Fremont, California, 94538, United States

  • Kaiser Permanente-Fresno

    RECRUITING

    Fresno, California, 93720, United States

  • Kaiser Permanente-Modesto

    RECRUITING

    Modesto, California, 95356, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kaiser Permanente-Richmond

    RECRUITING

    Richmond, California, 94801, United States

  • Kaiser Permanente-Roseville

    RECRUITING

    Roseville, California, 95661, United States

  • Kaiser Permanente-San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • Kaiser Permanente-Santa Rosa

    RECRUITING

    Santa Rosa, California, 95403, United States

  • Kaiser Permanente-Santa Teresa-San Jose

    RECRUITING

    San Jose, California, 95119, United States

  • Kaiser Permanente-South Sacramento

    RECRUITING

    Sacramento, California, 95823, United States

  • Kaiser Permanente-South San Francisco

    RECRUITING

    South San Francisco, California, 94080, United States

  • Kaiser Permanente-Stockton

    RECRUITING

    Stockton, California, 95210, United States

  • Kaiser Permanente-Vallejo

    RECRUITING

    Vallejo, California, 94589, United States

  • Kaiser Permanente-Walnut Creek

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Kaiser San Rafael-Gallinas

    RECRUITING

    San Rafael, California, 94903, United States

  • Kingston Health Sciences Centre

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health Oshawa

    RECRUITING

    Oshawa, Ontario, L1G 2B9, Canada

  • Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • London Regional Cancer Program

    RECRUITING

    London, Ontario, N6A 4L6, Canada

  • Manhattan Eye Ear and Throat Hospital

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Hospital East

    RECRUITING

    Shiloh, Illinois, 62269, United States

  • Northwell Health/Center for Advanced Medicine

    RECRUITING

    Lake Success, New York, 11042, United States

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Rohnert Park Cancer Center

    RECRUITING

    Rohnert Park, California, 94928, United States

  • Royal Victoria Regional Health Centre

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Saint Vincent Hospital

    RECRUITING

    Erie, Pennsylvania, 16544, United States

  • Siteman Cancer Center at Christian Hospital

    RECRUITING

    St Louis, Missouri, 63136, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at Saint Peters Hospital

    RECRUITING

    City of Saint Peters, Missouri, 63376, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center at West County Hospital

    RECRUITING

    Creve Coeur, Missouri, 63141, United States

    Contact Email: •••••@•••••

  • Siteman Cancer Center-South County

    RECRUITING

    St Louis, Missouri, 63129, United States

    Contact Email: •••••@•••••

  • The Permanente Medical Group-Roseville Radiation Oncology

    RECRUITING

    Roseville, California, 95678, United States

  • Trillium Health Partners - Credit Valley Hospital

    RECRUITING

    Mississauga, Ontario, L5M 2N1, Canada

  • University Health Network-Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Waterloo Regional Health Network

    RECRUITING

    Kitchener, Ontario, N2G 1G3, Canada

    Contact Email: •••••@•••••

  • West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Wexford Health and Wellness Pavilion

    RECRUITING

    Wexford, Pennsylvania, 15090, United States

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