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HDR Focal: Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02918253
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : April 13, 2021
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: targeted focal HDR brachytherapy Radiation: Whole-gland HDR Brachytherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields
Actual Study Start Date : October 14, 2016
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Tumour visible on MRI
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
Radiation: targeted focal HDR brachytherapy
Active Comparator: No tumour visible on MRI
Whole-gland HDR Brachytherapy
Radiation: Whole-gland HDR Brachytherapy
Control/Standard of Care

Primary Outcome Measures :
  1. number of patients achieving biochemical control [ Time Frame: 2 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02918253

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Contact: Alejandro Berlin, MD

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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Alejandro Berlin, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT02918253    
Other Study ID Numbers: 16-5490
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Health Network, Toronto:
High dose-rate brachytherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases