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

Condition: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02163317

Sponsor: Case Comprehensive Cancer Center


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

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