Prostate cancer radiation showdown: SBRT vs. brachytherapy
NCT ID NCT06052683
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
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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
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About 208 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Sep 2029
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.
Show the full entry requirements Hide 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.
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The places running it
1 site. 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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Centre Intégré de Cancérologie, CHU de Québec-Université Laval
RECRUITINGQuébec, Quebec, G1J 1Z4, Canada
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Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Light-Based imaging aims to spot prostate cancer left behind after surgery
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer