HDR Focal: Feasibility Study

Study Overview
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Brief Summary
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Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life. This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer. Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function. This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.

Official Title
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HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: targeted focal HDR brachytherapy
* Radiation: Whole-gland HDR Brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumour visible on MRI<br>Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose | Radiation: targeted focal HDR brachytherapy<br> <br> |
| Active Comparator: No tumour visible on MRI<br>Whole-gland HDR Brachytherapy | Radiation: Whole-gland HDR Brachytherapy<br>* Control/Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients achieving biochemical control |  | 2 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High dose-rate brachytherapy