Clinical Trials /

Hypofractionated SBRT For Prostate Cancer

NCT00977860

Description:

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Hypofractionated SBRT For Prostate Cancer
  • Official Title: Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 09-031
  • NCT ID: NCT00977860

Conditions

  • Prostate Cancer

Purpose

The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.

Detailed Description

      Radiosurgery should be ideal for treating prostate cancer because:

        -  targeting accuracy for static targets is excellent, with an error of about 1mm,

        -  it can adjust for intra-fractional organ motion, reducing the volume of the target PTV
           and therefore the dose to surrounding organs,

        -  by using over one-hundred non-conplanar beams, the dose gradient between the prostate
           and surrounding tissues may be superior to that achieved with conventional linear
           accelerators,

        -  the radiobiology of prostate cancer may favor large dose per fractions.
    

Trial Arms

NameTypeDescriptionInterventions
SBRTOther

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically proven prostate adenocarcinoma
    
              -  Gleason score 2-7
    
              -  Biopsy within one year of date of registration
    
              -  Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
    
              -  T-stage and N-stage determined by physical exam and available imaging studies
                 (ultrasound, CT, and/or MRI)
    
              -  M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical
                 findings suggest possible osseous metastases.
    
              -  PSA ≤ 20 ng/dL
    
              -  Patients belonging in one of the following risk groups:
    
              -  Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
    
              -  Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and
                 PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
    
              -  Prostate volume: ≤ 100 cc
    
              -  Determined using: volume = π/6 x length x height x width
    
              -  Measurement from CT or ultrasound ≤90 days prior to registration.
    
              -  ECOG performance status 0-1
    
              -  Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26
                 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices
                 questionnaire
    
              -  Consent signed.
    
            Exclusion Criteria:
    
              -  Prior prostatectomy or cryotherapy of the prostate
    
              -  Prior radiotherapy to the prostate or lower pelvis
    
              -  Implanted hardware or other material that would prohibit appropriate treatment
                 planning or treatment delivery, in the investigator's opinion.
    
              -  Chemotherapy for a malignancy in the last 5 years.
    
              -  History of an invasive malignancy (other than this prostate cancer, or basal or
                 squamous skin cancers) in the last 5 years.
    
              -  Hormone ablation for two months prior to enrollment, or during treat
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:To determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher GI and GU toxicity observed during a 24 month follow up
    Time Frame:24 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:To determine the rate of local failure, the rate of distant failure, the overall survival, the quality of life in generic and organ-specific domains
    Time Frame:24 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Pittsburgh

    Trial Keywords

    • Prostate
    • Stereotactic
    • Radiosurgery

    Last Updated

    December 4, 2018