LDR vs. HDR Brachytherapy for Prostate Cancer

N/AActive Not RecruitingNCT03426748

British Columbia Cancer Agency140 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Prostate Cancer

Interventions

Low dose rate prostate brachytherapyRADIATION

Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance

High dose rate prostate brachytherapyRADIATION

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

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

British Columbia Cancer Agency Center for the Southern Interior

Kelowna, British Columbia, Canada

Outcomes

Primary Outcomes

The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.

The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.

Time frame: 0-60 months

Secondary Outcomes

Quality of Life in the bowel and sexual domains

The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months

Time frame: 0-60 months

Time to return to baseline +/- 3 points for the International Prostate Symptom Score

The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24, 36, 48 and 60 months

Time frame: 0-60 months

Acute and long term toxicity

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: [Time Frame: 0-10 years]

Biochemical Outcome

PSA will be recorded every 6 months to 5 years and then annually to 10 years

Time frame: 5-10 years

Histologic Outcome

Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment

Time frame: 3 years

Cell cycle progression score

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.

Data from ClinicalTrials.gov

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