Clinical Trials /

LDR vs. HDR Brachytherapy for Prostate Cancer

NCT03426748

Description:

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

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03426748

Trial Eligibility

Document

Title

  • Brief Title: LDR vs. HDR Brachytherapy for Prostate Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: H17-02904
  • NCT ID: NCT03426748

Conditions

  • Prostate Cancer

Purpose

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

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.

Trial Arms

NameTypeDescriptionInterventions
Low dose rate brachytherapyActive ComparatorDevice: 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.
    High dose rate brachytherapyExperimentalDevice: 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.

      Eligibility Criteria

              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

               -  -< 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
      Maximum Eligible Age:80 Years
      Minimum Eligible Age:40 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.
      Time Frame:0-36 months
      Safety Issue:
      Description:The urinary domain of the EPIC prostate cancer specific QOL questionnaire will be assessed.

      Secondary Outcome Measures

      Measure:Quality of Life in the bowel and sexual domains
      Time Frame:0-36 months
      Safety Issue:
      Description:The EPIC score in the bowel and sexual domains will be evaluated at baseline, 1, 3, 6, 12, 24 and 36 months
      Measure:Time to return to baseline +/- 3 points for the International Prostate Symptom Score
      Time Frame:0-36 months
      Safety Issue:
      Description:The IPS Score will be assessed at baseline, 1, 3, 6, 12, 24 and 36 months
      Measure:Acute and long term toxicity
      Time Frame:[Time Frame: 0-10 years]
      Safety Issue:
      Description:Acute and long-term toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE V4) at each follow up time point
      Measure:Biochemical Outcome
      Time Frame:5-10 years
      Safety Issue:
      Description:PSA will be recorded every 6 months to 5 years and then annually to 10 years
      Measure:Histologic Outcome
      Time Frame:3 years
      Safety Issue:
      Description:Prostate re-biopsy will be performed at 36 months to assess the local efficacy of treatment
      Measure:Cell cycle progression score
      Time Frame:1 month to 10 years
      Safety Issue:
      Description: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.
      Measure:Tumor oxygenation and cell cycle distribution
      Time Frame:1 month to 10 years.
      Safety Issue:
      Description: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

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:British Columbia Cancer Agency

      Trial Keywords

      • Brachytherapy
      • Quality of life
      • High dose rate vs. low dose rate
      • Intermediate risk group

      Last Updated

      October 19, 2020