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HDR Focal: Feasibility Study

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
targeted focal HDR brachytherapy
Whole-gland HDR Brachytherapy
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring High dose-rate brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tumour visible on MRI

No tumour visible on MRI

Arm Description

Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose

Whole-gland HDR Brachytherapy

Outcomes

Primary Outcome Measures

number of patients achieving biochemical control

Secondary Outcome Measures

Full Information

First Posted
September 27, 2016
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02918253
Brief Title
HDR Focal: Feasibility Study
Official Title
HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2016 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
High dose-rate brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumour visible on MRI
Arm Type
Experimental
Arm Description
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
Arm Title
No tumour visible on MRI
Arm Type
Active Comparator
Arm Description
Whole-gland HDR Brachytherapy
Intervention Type
Radiation
Intervention Name(s)
targeted focal HDR brachytherapy
Intervention Type
Radiation
Intervention Name(s)
Whole-gland HDR Brachytherapy
Intervention Description
Control/Standard of Care
Primary Outcome Measure Information:
Title
number of patients achieving biochemical control
Time Frame
2 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Berlin, MD
Email
alejandro.berlin@rmp.uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Berlin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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HDR Focal: Feasibility Study

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