Clinical Trial Details

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Study ID ACCP002.2
Investigator
Donald B Fuller, MD,   CyberKnife Centers at San Diego, CA
George Mardirossian, PhD,   CyberKnife Centers of San Diego, CA
Title CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Conditions Prostate Cancer
Prostatic Cancer
Prostatic Neoplasms
Prostate Neoplasms
Cancer of the Prostate
Interventions Radiation: CyberKnife Stereotactic Radiosurgery
Phase Phase 2
Purpose The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Patient must be at least 18 years of age
  • Histologically proven prostate adenocarcinoma
  • Biopsy within 1 year of date of registration
  • Clinical Stage T1b-T2b, N0, M0
  • Patients belonging to one of the following risk categories:
  • Low Risk: CS T1b-T2a, Gleason Score 2-6, PSA < or = 10 ng/ml
  • Intermediate Risk: CS T2b, Gleason Score 2-6, PSA < or = 10 ng/ml or CS T1b-T2b, Gleason Score 2-6, PSA < or = 20 ng/ml or CS T1b-T2b, Gleason Score 7 and PSA < or = 10 ng/ml
  • ECOG performance status 0-1
Exclusion Criteria:
  • Clinical Stage T2c or greater
  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy fo the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or delivery
  • History of an invasive malignancy other than basal or squamous skin cancers in the last 5 years
  • Hormone ablation for two months prior to enrollment or during treatment
Study Location
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, 36604
Contact N/A

Information objtained from ClinicalTrials.gov, on 7/29/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643617


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