Could two radiation doses beat five for prostate cancer?
NCT ID NCT06835725
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving prostate cancer radiation in just 2 sessions is as safe and effective as the standard 5-session approach. About 100 men with low- or intermediate-risk prostate cancer will be randomly assigned to one of the two schedules. Both groups will use advanced prostate tracking and a rectal spacer to protect nearby organs. The study also explores whether an AI tool can improve targeting, but it won't be used to guide actual treatment yet.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic Body Radiation Therapy (SBRT) with prostate tracking and rectal spacer
- What this could lead to
- If successful, this could show that a 2-session radiation approach is as safe and effective as the standard 5-session one, offering men a quicker, more convenient treatment option with fewer side effects.
- What could go wrong
- This is a mid-stage trial with only 100 participants, so results may not apply to all patients. The 2-session method uses higher radiation doses per session, which could increase side effects despite precautions.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Apr 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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. * Able to provide informed consent. * ECOG performance status 0 - 2. * Fit for all protocol treatment and follow-up. * Life Expectancy \> 5 years. * Histologically confirmed adenocarcinoma of the prostate, NCCN low or intermediate risk, with biopsy performed within the last 18 months: Low risk = cT1-T2a,Gleason ≤ 6, and PSA \< 10ng/mL. Intermediate risk = at least one of: cT2b/T2c, PSA 10-20ng/mL, or Gleason 7, but not high risk. * 6 months of Androgen Deprivation Therapy (ADT) is permitted for those with NCCN unfavorable intermediate risk disease (aka high-tier intermediate risk disease), defined as intermediate risk disease with one or more of: two or three intermediate risk features, Gleason 4+3, or ≥50% biopsy cores positive. * For those with NCCN unfavorable intermediate risk disease, it is permitted for ADT to have been initiated prior to study enrollment provided it is possible for radiotherapy to be completed before completion of 6 months of ADT. * Prostate volume \<100cc based on imaging or digital rectal examination. * PSA within 90 days prior to registration. If ADT is started before registration, then the PSA must have been done no more than 90 day prior to the date of the first ADT injection. * CT abdomen and pelvis within the 6 months prior to registration (may be omitted for NCCN low risk participants). If particpant started on ADT prior to registration, CT should be done before first ADT injection. * Bone scan within the 6 months prior to of registration (may be omitted for NCCN low risk participants). If particpant started on ADT prior to registration, bone scan should be done before first ADT injection. * Must be appropriate for and willing to undergo implantation of prostate fiducial markers and Space OAR Hydrogel. Exclusion Criteria: Clinical stage cT3 or greater. Gleason score 8 or greater. PSA \> 20ng/mL or greater. NCCN high or very high risk. Pelvic nodal metastases. Distant metastases. Previous malignancy within the last 5 years except basal or squamous cell carcinomas of the skin. Previous pelvic radiotherapy. Any prior active local treatment for prostate cancer. Participants previously on active surveillance are eligible if they continue to meet all other eligibility criteria. Unilateral or Bilateral hip prostheses. Medical conditions likely to make radiotherapy inadvisable (e.g., inflammatory bowel disease). Medical condition that would make implantation of fiducial markers or hydrogel rectal spacer unsafe, in the opinion of the treating physician (e.g., pelvic or prostate abscess). Medical condition or implant that prohibits MRI (e.g. pacemaker) Trans-urethral resection of the prostate (TURP), GreenLight Laser or Holmium Laser Prostate procedure within 6 months of radiotherapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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BC Cancer Radiation Oncology
RECRUITINGSurrey, British Columbia, V3V1Z2, Canada
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BC Cancer Radiation Oncology
RECRUITINGVictoria, British Columbia, V8R6V5, Canada
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