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Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate

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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