CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

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