HDR Focal: Feasibility Study

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Sep 27, 2016

Keywords

ClinConnect Summary

The HDR Focal Trial is studying a new treatment option for men with early-stage, low to intermediate-risk prostate cancer. Instead of treating the entire prostate gland, this study focuses on a technique called high dose rate (HDR) brachytherapy, which delivers concentrated radiation to specific areas of the prostate. This targeted approach aims to reduce side effects, such as urinary problems, rectal issues, and sexual difficulties, while still effectively treating the cancer. Researchers will use advanced imaging methods, like multiparametric MRI, to identify the exact location of the cancer, which helps ensure that the treatment is as precise as possible.

To participate in this trial, men aged 18 and older with a confirmed diagnosis of prostate cancer may be eligible, provided they have certain characteristics, such as low-risk disease and no previous significant treatments for prostate cancer. Participants can expect to undergo HDR brachytherapy treatment and will be closely monitored for any side effects or changes in their health. This trial is currently recruiting participants, and those interested should discuss it with their healthcare provider to determine if it’s a good fit for them.

Gender

ALL

Eligibility 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