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Prostate cancer radiation showdown: SBRT vs. brachytherapy

NCT ID NCT06052683

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares two types of radiation therapy for low-risk prostate cancer: SBRT (a precise, high-dose external beam treatment) and low-dose rate brachytherapy (implanting radioactive seeds). The goal is to see which causes fewer urinary and bowel side effects and leads to a better quality of life. About 208 men with low or favorable intermediate-risk prostate cancer will be randomly assigned to one of the two treatments.

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 (SBRT or low-dose rate brachytherapy with Iodine-125 seeds)
What this could lead to
If it works, this could show that SBRT causes fewer urinary and bowel side effects than brachytherapy, helping doctors choose the gentler option.
What could go wrong
This is a medium-sized trial comparing two established treatments, so no major breakthrough is expected. Results may not apply to higher-risk cancers.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 208 people

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

Started

Sep 2019

Expected to finish

Sep 2029

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: * Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 8 months). * Low-risk and favourable intermediate-risk prostate cancer patients are eligible according to the following definitions: Low-risk disease defined as: Clinical stage T1-T2a and Gleason 6 and PSA ≤ 10 ng/mL Favourable intermediate-risk cancer defined by a single NCCN intermediate risk factor: \[NCCN : National Comprehensive Cancer Network\] 1. Clinical stage T2b 2. PSA \> 10 but ≤ 20 ng/mL 3. Gleason 7 (3+4) Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) is optional and is left at the discretion of the treating physician. * Age ≥ 18 years * Eastern Cooperative Oncology Group performance status 0-1 * Patient considered medically fit for LDR brachytherapy * Prostate volume ≤ 60 cc, measured by Trans-Rectal UltraSound (TRUS), CT or MRI, within the last 6 months. * International Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed) * No alpha reductase inhibitors use within two weeks of randomization * No hormonal therapy is accepted * Patients must provide a study-specified informed consent form prior to study entry. * Patients must be willing and able to complete the EPIC-26, IPSS and SHIM questionnaires. \[EPIC-26: Expanded Prostate Cancer Index Composite score ; SHIM: Sexual Health Inventory for Men questionnaire\]. Exclusion Criteria: * Clinical or radiological evidence of metastatic disease or nodal involvement. * Clinical stage ≥ T2b. * Gleason score ≥ 4 + 3. * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years. * Prior radical surgery for carcinoma of the prostate, or prior TURP (Trans-Urethral Resection of the Prostate). * Prior pelvic radiotherapy or prior radiotherapy that would result in overlap of radiation fields. * Prior chemotherapy for prostate cancer, or prior chemotherapy within the last 3 years. * Prior cryosurgery of the prostate. * Prior or current bleeding diathesis making fiducial placement or brachytherapy procedure unsafe. * Previous androgen deprivation therapy within 6 months of the registration. * Bilateral hip prostheses * Any severe active comorbidity, laboratory abnormality, psychiatric illnesses, active or uncontrolled infections, serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision). Such examples includes active inflammatory bowel disease, significant urinary symptoms,

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Centre Intégré de Cancérologie, CHU de Québec-Université Laval

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

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