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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
Full 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.
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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:
Selected intermediate risk patients not defined above
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.
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Primary purpose
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Interventional model
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140 participants in 2 patient groups
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Central trial contact
Juanita M Crook, MD
Data sourced from clinicaltrials.gov
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