Clinical Trials /

Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

NCT02163317

Description:

This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
  • Official Title: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CASE11813
  • SECONDARY ID: NCI-2014-01170
  • SECONDARY ID: CASE11813
  • SECONDARY ID: CASE 11813
  • SECONDARY ID: P30CA043703
  • NCT ID: NCT02163317

Conditions

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer

Purpose

This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed Description

      PRIMARY OBJECTIVES:

      I. Evaluate the correlation of histopathology findings in comparison to regions of the
      prostate reported to be suspicious for harboring tumor burden on multiparametric MRI
      report/s.

      II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body
      radiation therapy (SBRT) versus whole-gland radiation therapy.

      III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.

      OUTLINE:

      Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients
      undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months
      following the end of radiation therapy, and at 12 and 24 months.

      After completion of study treatment, patients are followed up every 3 months for up to 24
      months.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (MRI-guided focal SRS)ExperimentalPatients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patients must have a histologically confirmed diagnosis of adenocarcinoma of the
                 prostate
    
              -  Patient must have a history/physical examination with digital rectal examination of
                 the prostate within 90 days prior to screening
    
              -  Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1
                 within 60 days prior to registration
    
              -  Patient must have a histological evaluation of the prostate biopsy with assignment of
                 a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4)
    
              -  Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17
                 mL/min/1.73 m^2)
    
              -  Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer [AJCC] 7th edition)
    
              -  Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA
                 should not be obtained within 10 days after prostate biopsy
    
              -  Subjects must have the ability to understand and the willingness to sign a written
                 informed consent document
    
              -  Patient willing and able to complete the Expanded Prostate Cancer Index Composite
                 (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy)
    
              -  Patients must be able to undergo an MRI with contrast
    
              -  Bone scan completed within 90 days
    
            Exclusion Criteria:
    
              -  Evidence of distant metastases
    
              -  Regional lymph node involvement
    
              -  Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused
                 ultrasound (HIFU) for prostate cancer
    
              -  Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    
              -  Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH)
                 agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix),
                 anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol
                 [DES]), or surgical castration (orchiectomy)
    
              -  Use of finasteride within 30 days prior to registration; PSA should not be obtained
                 prior to 30 days after stopping finasteride
    
              -  Use of dutasteride within 90 days prior to registration; PSA should not be obtained
                 prior to 90 days after stopping dutasteride
    
              -  Previous or concurrent cytotoxic chemotherapy for prostate cancer
    
              -  Severe, active co-morbidity, defined as follows:
    
              -  Unstable angina and/or congestive heart failure requiring hospitalization within the
                 last 6 months
    
              -  Transmural myocardial infarction within the last 6 months
    
              -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time of
                 registration
    
              -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                 requiring hospitalization or precluding study therapy at the time of registration
    
              -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note,
                 however, that laboratory tests for liver function and coagulation parameters are not
                 required for entry into this protocol; (patients on Coumadin or other blood thinning
                 agents are eligible for this study)
    
              -  Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and
                 Control (CDC) definition; note, however, that human immunodeficiency virus (HIV)
                 testing is not required for entry into this protocol; protocol-specific requirements
                 may also exclude immuno-compromised patients
    
              -  Patients unable to undergo an MRI with contrast
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of patients with change in EPIC bowel domain score that was worse than 5 points
    Time Frame:Up to 1 year from start of study
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:PSA response
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Number of patients with PSA failure. Failure occurs when the PSA is first noted to be 2 ng/mL or more than the patient's nadir value post radiation therapy completion
    Measure:Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
    Time Frame:Up to 30 days after the completion of radiation therapy
    Safety Issue:
    Description:Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.
    Measure:Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy.
    Measure:Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.
    Measure:Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion.
    Measure:Number of patients with Disease-free survival
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Defined as From the date of treatment to the date of documentation of disease progression or until the date of death from any cause. Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Also, 95% confidence intervals will be reported. Descriptive reports of Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) and volumetric findings will be provided.
    Measure:Time to local progression
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.
    Measure:Time to distant failure
    Time Frame:Up to 2 years from start of study
    Safety Issue:
    Description:Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Case Comprehensive Cancer Center

    Last Updated

    May 28, 2019