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Brachytherapy + Stereotactic Radiotherapy for Prostate Cancer (fBTsRT Trial)

Phase 2
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
Imaging visible disease encompassing < 50% of the prostate gland and consistent with biopsy findings.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 months
Awards & highlights

Summary

This trial will compare the effect of fBT+sRT to standard care on urinary toxicity by examining how many patients experience a decline in urinary quality of life.

Who is the study for?
This trial is for men with prostate cancer who are planning to receive HDR brachytherapy boost alongside external beam radiotherapy. They should be in good physical condition (ECOG 0-1), have a low risk of other health issues (Charlson Comorbidity Index ≤ 4), and have visible disease in less than half of the prostate gland that matches biopsy results.
What is being tested?
The study is testing if combining focal High Dose Rate (HDR) Brachytherapy Boost with Stereotactic Radiotherapy (sRT) leads to better quality of life by reducing urinary irritation compared to standard treatments for prostate cancer.
What are the potential side effects?
While specific side effects aren't listed, typical ones from these treatments may include urinary issues, discomfort at the treatment site, fatigue, bowel changes, and sexual dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prostate cancer and am scheduled for a specific radiation treatment aimed at curing it.
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My prostate cancer affects less than half of my prostate, as shown by imaging and confirmed by biopsy.
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I am fully active and can carry on all my pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 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
Urinary Quality of Life

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
372 Previous Clinical Trials
130,881 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,959 Patients Enrolled for Prostate Cancer

Media Library

Stereotactic Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04100174 — Phase 2
Prostate Cancer Research Study Groups:
Prostate Cancer Clinical Trial 2023: Stereotactic Radiotherapy Highlights & Side Effects. Trial Name: NCT04100174 — Phase 2
Stereotactic Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04100174 — Phase 2
~2 spots leftby Oct 2024
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