Comparing Low-Dose Rate Brachytherapy to the with Stereotactic Body Radiation Therapy to for prostate cancer
Official title: A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.
A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.
- 2 groups
- One site, in Québec
- Recruiting
Interventions
- Radiation therapy
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
- Radiation therapy
Stereotactic Body Radiation Therapy to the prostate
Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years
- +Eastern Cooperative Oncology Group performance status 0-1
- +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 protocolProtocolThe detailed plan a study must follow.Read more → as long as they meet the eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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:
- +\[NCCN : National Comprehensive Cancer Network\]
- +Clinical stage T2b
- +PSA \> 10 but ≤ 20 ng/mL
- +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.
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- +No hormonal therapy is accepted
- +Patients must provide a study-specified informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
- −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 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 protocolProtocolThe detailed plan a study must follow.Read more → (according to investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s decision). Such examples includes active inflammatory bowel disease, significant urinary symptoms,
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant.
Registry label: A: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
Group B receives Stereotactic Body Radiation Therapy to the prostate.
Registry label: B: Stereotactic Body Radiation Therapy to the prostate
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 208 people.
The study is currently expected to finish around September 2029.
The main measurement is taken over: 1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB — measured over 1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06052683 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantRadiation
Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Stereotactic Body Radiation Therapy to the prostateRadiation
Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years..
The study as a whole is currently expected to finish around 2029-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 208 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.