Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
18 Years
N/A
Male
Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Trial Information
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Robert Meier, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Swedish Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ACCP001.3
NCT ID:
NCT00643994
Start Date:
December 2007
Completion Date:
January 2019
Related Keywords:
- Prostate Cancer
- Prostatic Cancer
- Prostate Neoplasms
- Prostatic Neoplasms
- Cancer of the Prostate
- Prostate Cancer
- CyberKnife
- Stereotactic Radiosurgery
- Radiotherapy
- Radiation
- Prostate Tumor
- Prostate Surgery
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| Community Cancer Center | Normal, Illinois 61761 |
| St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
| Hematology Oncology Associates of Central New York | Syracuse, New York 13217-6962 |
| Saint Louis University | St. Louis, Missouri 63104 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Southwest Washington Medical Center | Vancouver, Washington 98664 |
| St. Mary's Regional Medical Center | Reno, Nevada 89503 |
| Scripps Cancer Center - CyberKnife of Southern California at Vista | La Jolla, California 92037 |
| The CyberKnife at Newport Diagnostic Center | Newport Beach, California 92660 |
| Coastal CyberKnife and Radiation Oncology | Fort Pierce, Florida 34982 |
| Jupiter Medical Center & CyberKnife Center of Palm Beach | Jupiter, Florida 33458 |
| Lake Saint Louis Oncology | Saint Louis, Missouri 63367 |
| Capital Health | Trenton, New Jersey 08618 |
| Virginia Hospital Center | Arlington, Virginia 22205 |
| Swedish Cancer Center | Seattle, Washington 98122 |
| Southwest Washington Regional Cancer Center | Vancouver, Washington 98664 |
| ThedaCare Appleton Medical Center | Appleton, Wisconsin 54911 |
