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Brachytherapy

HDR Brachytherapy for Prostate Cancer (SalvageHDR Trial)

N/A
Recruiting
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No late toxicity from prior EBRT > grade 2
Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
Must not have
Unable to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of High Dose Rate (HDR) salvage brachytherapy for men with localized prostate cancer.

Who is the study for?
Men over 45 with a life expectancy of more than 10 years, who have had prostate cancer return after external beam radiotherapy. They should not have severe late side effects from previous treatments, must be able to undergo advanced MRI scans, and have confirmed localized recurrence suitable for high dose brachytherapy. Patients with inflammatory bowel disease or prior rectal surgery can't join.
What is being tested?
The trial is testing High Dose Rate (HDR) partial prostate brachytherapy on patients whose prostate cancer has returned post-radiotherapy. It focuses on the area identified by mpMRI as having recurrent cancer, aiming to see if targeted HDR brachytherapy can effectively treat these local recurrences.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with HDR brachytherapy may include discomfort or bruising at the implant site, urinary symptoms like frequency or urgency, bowel changes, erectile dysfunction and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not experienced severe side effects from previous radiation therapy.
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My cancer has returned and is suitable for a specific radiation treatment as determined by ultrasound.
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I am fit for surgery under anesthesia, including spinal or general.
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I have not had surgery to remove part of my prostate.
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I am older than 45 and expected to live more than 10 years.
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My diagnosis of DIL was confirmed by a biopsy reviewed by a specific pathologist.
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My bladder empties well and my urine flow is strong.
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My prostate cancer has returned in the same place as before.
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I have never had inflammatory bowel disease or rectal surgery.
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I've had radiation therapy with specific dose limits.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Late adverse gastrointestinal or genitourinary events grade 3 or higher
Secondary study objectives
Acute Quality of Life changes
Acute grade 3 or higher gastrointestinal or genitourinary adverse events
Acute lower urinary symptoms
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HDR partial prostate brachytherapyExperimental Treatment1 Intervention
2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
176 Previous Clinical Trials
95,198 Total Patients Enrolled
22 Trials studying Prostate Cancer
4,208 Patients Enrolled for Prostate Cancer
Mira Keyes, MDStudy DirectorBCCA

Media Library

HDR partial prostate brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03246802 — N/A
Prostate Cancer Research Study Groups: HDR partial prostate brachytherapy
Prostate Cancer Clinical Trial 2023: HDR partial prostate brachytherapy Highlights & Side Effects. Trial Name: NCT03246802 — N/A
HDR partial prostate brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246802 — N/A
~0 spots leftby Dec 2024
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