LDR vs. HDR Brachytherapy for Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    140
  • sponsor
    British Columbia Cancer Agency
Updated on 26 January 2021
androgens
antiandrogen therapy
androgen suppression
brachytherapy
transrectal ultrasound

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

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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Low dose rate prostate brachytherapy, High Dose Rate prostate brachytherapy
Clinical Study IdentifierNCT03426748
SponsorBritish Columbia Cancer Agency
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
% 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 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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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