NCT02918253Active, not recruiting

HDR Focal: Feasibility Study

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

Source: ClinicalTrials.gov · Last updated 22 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 60 (estimated)
First submitted: 27 Sept 2016
Start date: 14 Oct 2016
Primary completion date: Nov 2027
Lead sponsor: University Health Network, Toronto
Diseases: Prostate cancer
NCT number: NCT02918253

What you commit to

Study type: Interventional
Planned participants: 60
From 14 Oct 2016 to the primary completion date, Nov 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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
Baseline IPSS \<18
No TURP 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 (except for patients where clinician determines benefit outweighs the risk of radiation)
Absence of latex allergy
No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Princess Margaret Cancer Centre Coordinator of this site? Confirm its status	Toronto	Canada	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.