Testing radiotherapy for prostate cancer
Official title: Radiation Treatment of the Prostate That is Specially Adjusted for Each Person
DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE
Interventions
radiotherapy
External beam radiotherapy via stereotactic body radiotherapy (SBRT).
Canadian Sites (1)
Jack Ady Cancer Centre
Lethbridge, Alberta, Canada
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Histologically confirmed adenocarcinoma of the prostate
- +NCCN risk grouping of intermediate or high risk prostate cancer
- +Patients must be 18 years of age, or older on the day of signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and be willing and able to provide written informed consent/assent
- +Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
- +Have not received prior pelvic radiotherapy
- +Life expectancy greater than 10 years
- +ECOG performance status \<3
- +Eligible for SBRT to the prostate
- +Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
Exclusion
- −No identifiable lesion within the prostate on 3T MRI
- −Prior trans-urethral resection of the prostate
- −Non-adenocarcinoma histology
- −Meeting criteria for very high-risk risk or node positive prostate cancer
- −Active inflammatory bowel disease
- −Evidence of metastatic disease on CT or bone scan
- −Declined radiotherapy
- −Unlikely to be available for all follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → appointments
- −Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy
- −Unable to understand or sign a study consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → after use of interpreter if required
- −Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma
- −Unable to tolerate or ineligible for mpMR imaging
- −Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
- −Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible
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.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: radiotherapy.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
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.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
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 50 people.
The study is currently expected to finish around June 2032.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 3 weeks (includes treatment period for ArmArmOne of the groups in a study, each receiving something different.Read more → 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 3 weeks (includes treatment period for ArmArmOne of the groups in a study, each receiving something different.Read more → 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07578519 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 radiotherapyRadiation
External beam radiotherapy via stereotactic body radiotherapy (SBRT).
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.
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.
Groups are assigned by the study team using set rules, rather than by chance.
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: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 3 weeks (includes treatment period for ArmArmOne of the groups in a study, each receiving something different.Read more → 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years.
The study as a whole is currently expected to finish around 2032-06.
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 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Lethbridge, Alberta, 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
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer. For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
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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.