Clinical Trials /

Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

NCT01508390

Description:

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
  • Official Title: Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: H-29665
  • NCT ID: NCT01508390

Conditions

  • Prostate Cancer

Purpose

In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.

Detailed Description

      In this study, participants will have standard androgen deprivation therapy and undergo
      standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated
      radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will
      be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation
      Therapy. This study will also see how CyberKnife affects the quality of the participant's
      life.
    

Trial Arms

NameTypeDescriptionInterventions
BoostExperimentalCyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Histologically proven adenocarcinoma of the prostate a. Gleason score (2-10) b. Biopsy
                 within six months of date of registration
    
              2. Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined
                 by physical exam i. MRI findings (e.g. extracapsular extension) should not influence
                 T-staging, but should be noted for later analysis b. N-stage determined using
                 abdominopelvic CT scan c. M-stage determined by physical exam, CT and/or MRI, and bone
                 scan
    
              3. Patients must belong to one of the following risk groups: a. Very High risk: Stage cT3
                 and Gleason 8-10 and prostate-specific antigen less than 150 b. High risk: Stage
                 cT1-T2 and Gleason 8-10 and prostate-specific antigen less than 150 c. Moderate high
                 risk: Stage cT3 and Gleason 7 and any prostate-specific antigen. Intermediate to high
                 risk (a) Stage cT3 and Gleason 6 and prostate-specific antigen at least 30 e.
                 Intermediate to high risk (b): Stage cT1-T2 and Gleason 7 and prostate-specific
                 antigen at least 30
    
              4. Patient is planned to undergo standard androgen deprivation therapy and initial
                 Intensity Modulated Radiation Therapy (IMRT) to the prostate and at-risk lymph nodes.
    
              5. Prostate volume greater than 20 cc and less than 100 cc
    
              6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    
              7. Patient has agreed to complete questionnaires
    
              8. Signed Institutional Review Board (IRB) approved informed consent
    
            Exclusion Criteria:
    
              1. No prior prostate surgery or prostate cancer treatment
    
              2. No prior radiotherapy to the pelvis
    
              3. No implanted hardware or other material that would prohibit appropriate treatment
                 planning or treatment delivery
    
              4. No chemotherapy for a malignancy in the last 5 years.
    
              5. No history of an invasive malignancy (other than basal or squamous skin cancers) in
                 the last 5 years.
    
              6. No history of a horseshoe kidney
    
              7. No diagnosis of inflammatory bowel disease
    
              8. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm
                 clip in the brain
    
              9. Must be able to tolerate the confinement of an MRI procedure
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Document rate of biochemical Disease-Free Survival (bDFS)
    Time Frame:5 years
    Safety Issue:
    Description:To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions

    Secondary Outcome Measures

    Measure:Rate of local failure
    Time Frame:5 years
    Safety Issue:
    Description:Rate of local failure
    Measure:Rate of distant failure
    Time Frame:5 years
    Safety Issue:
    Description:Rate of distant failure
    Measure:disease-free survival
    Time Frame:5 years
    Safety Issue:
    Description:disease-free survival
    Measure:Rate of disease-specific survival
    Time Frame:5 years
    Safety Issue:
    Description:Rate of disease-specific survival
    Measure:Rate of overall survival
    Time Frame:5 years
    Safety Issue:
    Description:Rate of overall survival
    Measure:Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
    Time Frame:5 years
    Safety Issue:
    Description:rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Boston Medical Center

    Trial Keywords

    • prostate

    Last Updated

    November 11, 2019