Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02918253

HDR Focal: Feasibility Study

Led by University Health Network, Toronto · Updated on 2025-03-06

30

Participants Needed

1

Research Sites

580 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HDR Focal: Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status of 0 to 2
  • Histological confirmation of prostate adenocarcinoma
  • Low- and favorable intermediate-risk prostate cancer
  • Signed informed consent acknowledging investigational nature and risks
  • No contraindications to MRI
  • Absent or unifocal intraprostatic disease with fewer than 2 distinct lesions on multiparametric MRI
  • Prostate gland size less than 80cc
  • Baseline International Prostate Symptom Score (IPSS) less than 18
  • No transrectal ultrasound prostate biopsy within the past 6 months and no large transurethral resection of the prostate defect
  • No radiological evidence of regional or distant metastases (optional, at physician discretion)
  • No prior pelvic or prostate external beam radiation therapy or brachytherapy
  • No contraindications to general or spinal/epidural anesthesia
  • No bleeding disorders or anticoagulant therapy that cannot be temporarily stopped during brachytherapy
  • No contraindications to endorectal coil, no surgically absent rectum, severe hemorrhoids, or colorectal surgery
  • No history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or systemic lupus erythematosus
  • No latex allergy
  • No other medical conditions that would make the patient ineligible for prostate HDR brachytherapy as determined by the principal investigator
Not Eligible

You will not qualify if you...

  • Contraindications to MRI
  • More than one or multifocal intraprostatic lesions on multiparametric MRI
  • Prostate gland size 80cc or greater
  • Baseline IPSS 18 or higher
  • Transrectal ultrasound prostate biopsy within the past 6 months or large transurethral resection of the prostate defect
  • Radiological evidence of regional or distant metastases (unless physician permits)
  • Previous pelvic or prostate external beam radiation therapy or brachytherapy
  • Contraindications to general or spinal/epidural anesthesia
  • Presence of bleeding disorders or ongoing anticoagulation that cannot be paused during brachytherapy
  • Contraindications to endorectal coil, history of rectal surgery, severe hemorrhoids, or absent rectum
  • History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or systemic lupus erythematosus
  • Latex allergy
  • Other medical conditions deemed unsuitable for prostate HDR brachytherapy by the principal investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

A

Alejandro Berlin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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