LDR vs. HDR Brachytherapy for Prostate Cancer

Last updated: March 11, 2025
Sponsor: British Columbia Cancer Agency
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Urologic Cancer

Treatment

Low dose rate prostate brachytherapy

High dose rate prostate brachytherapy

Clinical Study ID

NCT03426748
H17-02904
  • Ages 40-80
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 intermediaterisk 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

  • -< 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

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 Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Low dose rate prostate brachytherapy
Phase:
Study Start date:
February 15, 2018
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • British Columbia Cancer Agency Center for the Southern Interior

    Kelowna, British Columbia V1Y5L3
    Canada

    Site Not Available

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