Clinical Trials /

Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

NCT01581749

Description:

The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer
  • Official Title: Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: R12-3104L
  • NCT ID: NCT01581749

Conditions

  • Prostate Neoplasms

Purpose

The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

Detailed Description

      The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.

      At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following
      treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12,
      EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals
      (and every 6 months thereafter, through year 5, and annually through year 10, if
      investigators opt to continue past year 5), patients will be seen and evaluated, including a
      history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In
      addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and
      Utilization of Sexual Medications/Devices will be administered. Examination and studies may
      be done at outside facility.

      A prostate biopsy will be performed at time of biochemical or local clinical failure, and is
      encouraged at 2 years following treatment and at time of distant failure.
    

Trial Arms

NameTypeDescriptionInterventions
36.25Gy to prostate in 5 fractionsOther36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  histologically proven prostate adenocarcinoma within 1 year of enrollment
    
              -  Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0
    
              -  Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 &
                 PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical
                 Stage T1b- T2b, Nx or NO, Mx or M0
    
              -  ECOG Performance Status 0-1
    
              -  No prior prostate radiation or other definitive therapy
    
            Exclusion Criteria:
    
              -  implanted hardware or other material that would prohibit treatment planning or
                 delivery
    
              -  chemotherapy for a malignancy within the previous 5 years
    
              -  history of an invasive malignancy (other than this prostate cancer,or basal or
                 squamous skin cancers) within prior 5 years
    
              -  hormone ablation for 2 months prior to treatment or during treatment
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:21 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:acute and late GI/GU toxicity rate following treatment
    Time Frame:5 years
    Safety Issue:
    Description:The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.

    Secondary Outcome Measures

    Measure:a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy
    Time Frame:5 years
    Safety Issue:
    Description:For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients.

    Details

    Phase:Phase 4
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Albert DeNittis

    Trial Keywords

    • low risk prostate cancer
    • intermediate risk prostate cancer
    • stereotactic radiosurgery

    Last Updated

    March 22, 2016