The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

Official Title

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution.

Conditions

  • Prostate Cancer
  • Prostatic Cancer
  • Prostate Neoplasms
  • Prostatic Neoplasms
  • Cancer of the Prostate

Study Type

Interventional

Study Design

Treatment, Open Label, Single Group Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

  • To estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities observed following CyberKnife treatment for prostate cancer.
    [Time Frame: 5 years]
    [Designated as safety issue: No]
  • To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix and ASTRO definitions, following CyberKnife treatment.
    [Time Frame: 5 years]
    [Designated as safety issue: No]

Secondary Outcome Measures:

  • To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, overall survival and quality of life following CyberKnife treatment in prostate cancer patients.
    [Time Frame: 5 years]
    [Designated as safety issue: No]

Study Start

December 2007

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Male
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Histologically proven prostate adenocarcinoma
  • Patients belonging in one of the following risk groups:
  • Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml
  • Prostate volume: ≤ 100 cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator’s opinion
  • Chemotherapy for a malignancy in the last 5 years
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
  • Hormone ablation for two months prior to enrollment, or during treatment.

Total Enrolment

298

Contact Details

Joanne N Davis, PhD     
248-719-2998     
jdavis@accuray.com

Omar Dawood, MD, MPH     
408-789-4457     
odawood@accuray.com 

Robert Meier, MD    
206-386-6707

Location:

Swedish Cancer Center
Seattle, Washington
United States, 98122 

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