Clinical Trials /

CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer

NCT01985828

Description:

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years. During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications. The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer
  • Official Title: Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 5307
  • NCT ID: NCT01985828

Conditions

  • Prostate Adenocarcinoma

Purpose

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years. During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications. The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

Trial Arms

NameTypeDescriptionInterventions
Intermediate RiskExperimentalShort term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy OR Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)
    High RiskExperimentalShort or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost

      Eligibility Criteria

              -  Patient must be ≥ 18 years of age.
      
                -  Histologically proven prostate adenocarcinoma
      
                     -  Gleason score 2-10 (reviewed by reference lab)
      
                     -  Biopsy within one year of date of registration
      
                     -  Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
      
                     -  T-stage and N-stage determined by physical exam and available imaging studies
                        (ultrasound, CT, and/or MRI; see section 4.5)
      
                     -  M-stage determined by physical exam, CT or MRI. Bone scan not required unless
                        clinical findings suggest possible osseous metastases.
      
                -  PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
      
                -  Patients belonging in one of the following risk groups:
      
                     -  Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7
                        and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
      
                     -  High: CS T3-4, Gleason score >7and PSA<50
      
                -  Prostate volume: ≤ 100 cc
      
                     -  Determined using: volume = π/6 x length x height x width
      
                     -  Measurement from MRI, CT or ultrasound prior to registration.
      
                -  ECOG performance status 0-1
      
                -  No prior prostatectomy or cryotherapy of the prostate
      
                -  No prior radiotherapy to the prostate or lower pelvis
      
                -  No implanted hardware or other material that would prohibit appropriate treatment
                   planning or treatment delivery, in the investigator's opinion.
      
                -  No chemotherapy for a malignancy in the last 5 years.
      
                -  No history of an invasive malignancy (other than this prostate cancer, or basal or
                   squamous skin cancers) in the last 5 years.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions
      Time Frame:5 years
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
      Time Frame:5 years
      Safety Issue:
      Description:
      Measure:Measure local failure rates
      Time Frame:5 years
      Safety Issue:
      Description:Measurement of local recurrence of prostate cancer
      Measure:Measure distant failure rates
      Time Frame:5 years
      Safety Issue:
      Description:Measurement of distant metastasis rate
      Measure:Measure clinical disease-free survival rates
      Time Frame:5 years
      Safety Issue:
      Description:
      Measure:Measure disease-specific survival rates
      Time Frame:5 years
      Safety Issue:
      Description:
      Measure:Measure Overall Survival
      Time Frame:5 years
      Safety Issue:
      Description:

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Advocate Health Care

      Trial Keywords

      • Prostate neoplasm
      • Prostate Cancer

      Last Updated

      July 10, 2019