Clinical Trials /

Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

NCT03056638

Description:

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions. Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation. This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
  • Official Title: Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 16-1686
  • NCT ID: NCT03056638

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
DegarelixDegarelix in conjunction with stereotactic body radiosurgery

Purpose

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions. Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation. This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Trial Arms

NameTypeDescriptionInterventions
Degarelix in conjunction with stereotactic body radiosurgeryExperimentalDegarelix monthly for 6 months SBRT 8 Gy x 5
  • Degarelix
stereotactic body radiosurgery (SBRT)ExperimentalSBRT 8 Gy x 5

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Biopsy proven intermediate risk prostate cancer, which includes patients with any one
                 of the following variables:
    
              -  Gleason 7 disease
    
              -  PSA 10-20 ng/ml
    
              -  Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3
                 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically)
                 will not be excluded.
    
              -  Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment
    
              -  At least 4 weeks must have elapsed from major surgery
    
              -  KPS ≥ 80%
    
              -  Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on
                 CT scan if MRI is not available.
    
              -  18 years of age or older
    
              -  IPSS ≤ 20
    
              -  Patient must be available for follow-up. After 2 years of follow-up following
                 post-treatment biopsy, telephone-based follow-up will be acceptable
    
              -  Laboratory test findings within 8 weeks of randomization:
    
                   -  Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper
                      institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a
                      history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3
                      mg/dL with a predominance of indirect bilirubin
    
                   -  Adequate renal function with serum creatinine ≤ 1.5 x ULN
    
                   -  Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3
                      and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patients
                      whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood
                      transfusions are allowed)
    
            Exclusion Criteria:
    
              -  CT or MRI evidence of metastatic disease to the bone.
    
              -  Patients with one or more positive lymph nodes considered suspicious as determined by
                 clinical assessment on MRI or CT
    
              -  Prior treatment for prostate cancer, including history of chemotherapy, hormonal
                 therapy within 30 days of enrollment or surgery for prostate cancer (except for prior
                 TURP which would be allowed)
    
              -  History of another malignancy within the previous 3 years except for the following:
                 adequately treated basal cell or squamous cell skin cancer, superficial bladder
                 cancer, currently in complete remission, or any other cancer that has been in
                 complete remission for at least 3 years
    
              -  Patients with Crohn's disease or ulcerative colitis
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:number of patients with a positive biopsy
    Time Frame:2 years
    Safety Issue:
    Description:compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • Androgen Deprivation Therapy
    • Ultra-Hypofractionated SBRT
    • 16-1686

    Last Updated

    April 19, 2017