| March 20, 2008 |
| September 29, 2009 |
| December 2007 |
| January 2014 (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: 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 ]
|
| Same as current |
| 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: 5 years ] [ Designated as safety issue: No ] |
| Same as current |
| |
| 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. |
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Efficacy Study |
- Prostate Cancer
- Prostatic Cancer
- Prostate Neoplasms
- Prostatic Neoplasms
- Cancer of the Prostate
|
| Radiation: CyberKnife Stereotactic Radiosurgery |
| |
| |
| |
| Recruiting |
| 298 |
| January 2014 |
| January 2014 (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 |
|
|
| United States |
| |
| NCT00643994 |
| Omar Dawood, Vice President of Clinical Development, Accuray Incorporated |
| ACCP001.2 |
| Accuray Incorporated |
|
| 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 |
| September 2009 |
