Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01985828

Sponsor: Advocate Health Care


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

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.

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