LDR vs. HDR Brachytherapy for Prostate Cancer (LDR/HDRmono)

January 28, 2026 updated by: British Columbia Cancer Agency

A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favorable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumor Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumor changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y5L3
        • British Columbia Cancer Agency Center for the Southern Interior

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.

  • Clinical stage T1c-T2b, PSA < 20, Gleason < 8
  • ECOG 0-1
  • Low tier intermediate-risk prostate cancer is defined by a single NCCN intermediate risk factor

  • Extensive favorable-risk disease is defined as:

    • clinical stage T1c-T2a
    • PSA < 10
    • Gleason 6
    • ≥ 50% of biopsy cores containing cancer
    • PSA density > 0.2 ng/cc

  • Selected intermediate risk patients not defined above

    • - T1c/T2a
    • - PSA < 10
    • -Gleason 4+3
    • PSA > 10 and Gleason 3+4
    • PSA 10-15 ng/ml and Gleason 4+3
    • -< 33% of cores involved
    • -Max tumor length in any core 10 mm
  • No androgen deprivation therapy (ADT)
  • Prostate volume by TRUS ≤ 60 cc.
  • Not eligible for, or accepting of, active surveillance according to NCCN guidelines.
  • Signed study specific informed consent.

Exclusion Criteria:

  • Prior radical surgery for carcinoma of the prostate,
  • Prior pelvic radiation
  • Prior chemotherapy for prostate cancer,
  • Prior TURP or cryosurgery of the prostate
  • Claustrophobic or unable to undergo MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose rate brachytherapy
Device: Radiation. Low dose rate prostate brachytherapy is delivered under anesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.
Radiation: Low dose rate prostate brachytherapy
Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
Other Names:
  • permanent seed implant
Experimental: High dose rate brachytherapy

Device: Radiation. High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anesthesia, but no follow-up imaging visit is required.

HDR brachytherapy is also accomplished as an out-patient.
Radiation: High dose rate prostate brachytherapy
Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
Other Names:
  • HDR brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
Time Frame: 0-60 months
The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.
0-60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Outcome
Time Frame: 5-10 years
PSA will be recorded every 6 months to 5 years and then annually to 10 years
5-10 years
Histologic Outcome
Time Frame: 3 years
Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
3 years
Acute and long term toxicity
Time Frame: [Time Frame: 0-10 years]
Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
[Time Frame: 0-10 years]
Cell cycle progression score
Time Frame: 1 month to 10 years
For those patients consenting to targeted biopsies under anesthesia at the start of their brachytherapy procedure (separate optional consent) MRI-TRUS fusion accuracy will be verified by targeted biopsies and Biopsy material will be sent for genetic testing to determine Cell cycle Progression scores for both arms of the trial to ultimately correlate with outcome.
1 month to 10 years
Tumor oxygenation and cell cycle distribution
Time Frame: 1 month to 10 years.
For patients receiving 2 fractions of high dose rate brachytherapy, biopsy between the 2 fractions will assess radiosensitivity by evaluating changes in oxygenation and cell cycle distribution between the 2 fractions, for ultimate correlation with efficacy
1 month to 10 years.
Quality of Life in the bowel and sexual domains
Time Frame: 0-60 months
The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months
0-60 months
Time to return to baseline +/- 3 points for the International Prostate Symptom Score
Time Frame: 0-60 months
The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months
0-60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation

Investigators

  • Study Director: Ross Halperin, MD, British Columbia Cancer Agency Program Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2034

Study Registration Dates

First Submitted

February 2, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-02904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Low dose rate prostate brachytherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe