Study of Stereotactic Body Radiotherapy (SBRT) for High-Risk Localized Prostrate Cancer

Condition: Adenocarcinoma of the Prostate, Stage III Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02296229

Sponsor: Jonsson Comprehensive Cancer Center


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

Inclusion Criteria:

  • Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
  • Risk-group classification into the D’Amico or National Comprehensive Cancer Network (NCCN) ‘high-risk’ group, as defined by the presence of any one of the following high-risk factors:
  • Pre-biopsy prostate-specific antigen (PSA) >= 20
  • Biopsy Gleason score 8-10
  • Clinical stage T3
  • No pelvic nodal metastases (based on computed tomography [CT] or magnetic resonance imaging [MRI] findings)
  • No distant metastases, based upon:
  • CT scan or MRI of the pelvis within 120 days prior to registration
  • Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
  • Karnofsky performance status (KPS) >= 70
  • Ability to understand, and willingness to sign, the written informed consent
  • Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria:

  • Patients with any evidence of distant metastases
  • Hormonal therapy (luteinizing hormone-releasing hormone [LHRH] agonist or oral anti-androgen) exceeding 4 months prior to registration
  • Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
  • Prior pelvic radiotherapy
  • History of Crohn’s disease or Ulcerative colitis

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