Feasibility of targeted high dose-rate brachytherapy for prostate cancer
HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields
This study is testing a new targeted radiation treatment for early-stage prostate cancer to see if it can reduce side effects while still being effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT02918253 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using high dose-rate (HDR) brachytherapy as a monotherapy for early-stage, favorable-risk prostate cancer. It focuses on a targeted approach, utilizing multiparametric MRI to identify well-defined disease areas, potentially reducing treatment-related toxicities while maintaining effective oncologic outcomes. The study compares focal HDR brachytherapy to traditional whole-gland HDR brachytherapy, aiming to improve patients' quality of life by minimizing urinary, rectal, and sexual side effects.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with low- to favorable intermediate-risk prostate adenocarcinoma and specific MRI findings.
Not a fit: Patients with advanced prostate cancer, multiple lesions, or those who have had prior pelvic radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related side effects for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise with HDR brachytherapy, but this specific focal approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * ECOG performance status 0 - 2 * Histological evidence of prostate adenocarcinoma * Low- and favorable intermediate-risk prostate cancer * Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed * No contraindications to MRI: * Absent or unifocal intraprostatic disease (\<2 separate/distinct lesions), on multiparametric MRI * Prostate gland size \<80cc * Baseline IPSS \<18 * No TRUP within the past 6 months, nor large TURP defect * Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion) * No previous pelvic and/or prostate EBRT and/or brachytherapy * No contraindications to general anesthesia, or spinal/epidural anesthesia * Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy * No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery * Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE * Absence of latex allergy * No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Alejandro Berlin, MD
- Email: alejandro.berlin@rmp.uhn.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.