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Eligibility
for males ages 18 years and up
Location
at Fresno, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Details

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.

Keywords

Prostate Cancer Prostatic Cancer Prostatic Neoplasms Prostate Neoplasms Cancer of the Prostate CyberKnife Stereotactic Radiosurgery Radiosurgery Prostate Tumor Prostate Surgery

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Pasadena Cyberknife Center
    Pasadena, California, 91105, United States
  • Long Beach Memorial Medical Center
    Long Beach, California, 90806, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89128, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Accuray Incorporated
Links
Accuray Website
ID
NCT00643617
Phase
Phase 2
Study Type
Interventional
Last Updated
July 1, 2016