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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT00643994
First received: March 20, 2008
Last updated: April 5, 2013
Last verified: April 2013

March 20, 2008
April 5, 2013
December 2007
January 2019   (final data collection date for primary outcome measure)
  • 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: 10 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: 10 years ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00643994 on ClinicalTrials.gov Archive Site
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: 10 years ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk 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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Prostatic Cancer
  • Prostate Neoplasms
  • Prostatic Neoplasms
  • Cancer of the Prostate
Radiation: CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Name: CyberKnife
Experimental: CyberKnife Stereotactic Radiosurgery
Intervention: Radiation: CyberKnife Stereotactic Radiosurgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
298
January 2019
January 2019   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643994
ACCP001.3
Yes
Accuray Incorporated
Accuray Incorporated
Not Provided
Study Chair: Robert Meier, MD Swedish Cancer Center
Study Chair: Irving Kaplan, MD Beth Israel Deaconess Medical Center
Study Chair: Martin Sanda, MD Beth Israel Deaconess Medical Center
Accuray Incorporated
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP