This trial is active, not recruiting.

Conditions prostate cancer, prostatic cancer, prostatic neoplasms, prostate neoplasms, cancer of the prostate
Treatment cyberknife stereotactic radiosurgery
Phase phase 2
Sponsor Accuray Incorporated
Start date November 2007
End date January 2019
Trial size 253 participants
Trial identifier NCT00643617, ACCP002.2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with CyberKnife Stereotactic Radiosurgery
cyberknife stereotactic radiosurgery CyberKnife
38 Gy delivered in 4 fractions of 9.5 Gy per fraction

Primary Outcomes

To determine biochemical disease free survival (using both ASTRO and Phoenix definitions) and measure the rates of acute and late genitourinary and gastrointestinal toxicities following CyberKnife radiosurgery.
time frame: 10 years
To compare the CyberKnife biochemical disease free survival rates (bDFS) to published HDR monotherapy bDFS rates reported in the literature.
time frame: 10 years

Secondary Outcomes

To measure the rates of local failure, distant failure, clinical-disease free survival, disease-specific survival, overall survival and quality of life.
time frame: 10 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Description In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by HDR brachytherapy treatment, without the use of invasive catheters. The radiosurgery volumes will closely be made to resemble HDR brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues. The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Accuray Incorporated.