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Recruiting
View on ClinicalTrials.gov

Testing HDR partial prostate brachytherapy for recurrent prostate cancer

Official title: Partial Prostate Salvage High Dose Rate Brachytherapy

High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy

Condition: Recurrent Prostate CancerSponsor: British Columbia Cancer AgencyTarget enrollment: 30
  • 1 group
  • One site, in Kelowna
  • Recruiting
BCCA Center for the Southern Interior, Kelowna, British Columbia

Interventions

  • Radiation therapy

    HDR partial prostate brachytherapy

    temporary radioactive implant

Canadian Sites (1)

1 of 1 recruiting

  • BCCA Center for the Southern Interior

    Kelowna, British Columbia

    Recruiting

Eligibility Criteria

See who this study is looking for12 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age \>45 and Life expectancy \>10 years
  • +Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w
  • +\> 3 year interval since EBRT or LDR Brachytherapy
  • +No late toxicity from prior EBRT ≥ grade 2
  • +PSA \> nadir + 2 ng/ml and \< 10 ng/ml
  • +PSA Doubling time \> 6 months
  • +Radiographic evidence corresponding with siteTrial siteA hospital or clinic where a study is actually run.Read more → of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).
  • +Per InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.
  • +Negative staging of the abdomen/pelvis and bones.
  • +Willing to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →

Exclusion

  • Not compliant with criteria above
  • Unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
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

Everyone in this study is in one group and receives HDR partial prostate brachytherapy.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

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.

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 45 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 30 people.

The study is currently expected to finish around January 2037.

The main measurement is taken over: 3-60 months.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Late adverse gastrointestinal or genitourinary events grade 3 or higher — measured over 3-60 months.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT03246802 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 HDR partial prostate brachytherapyRadiation

temporary radioactive implant

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 45 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.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 45 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: 3-60 months.

The study as a whole is currently expected to finish around 2037-01-01.

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 30 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Kelowna, British Columbia, 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 dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.

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This 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.