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


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

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Trial Information

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


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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine biochemical disease free survival (using both ASTRO and Phoenix definitions) and measure the rates of acute and late genitourinary and gastrointestinal toxicities following CyberKnife radiosurgery.

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Donald B Fuller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CyberKnife Centers at San Diego, CA

Authority:

United States: Institutional Review Board

Study ID:

ACCP002.2

NCT ID:

NCT00643617

Start Date:

November 2007

Completion Date:

January 2019

Related Keywords:

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

Name

Location

St. Anthony HospitalOklahoma City, Oklahoma  73101
Long Beach Memorial Medical CenterLong Beach, California  90806
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Penrose Cancer CenterColorado Springs, Colorado  80933
AtlantiCare Regional Medical CenterPomona, New Jersey  08240
University of North CarolinaChapel Hill, North Carolina  27599
Elmhurst Memorial HospitalElmhurst, Illinois  60126
Sarah Cannon Research InstituteNashville, Tennessee  37203
East Texas Medical CenterTyler, Texas  75701
Community Regional Medical CenterFresno, California  93721
Mitchell Cancer Center University of South AlabamaMobile, Alabama  36604
Pasadena Cyberknife CenterPasadena, California  91105
CyberKnife Centers of San DiegoSan Diego, California  92101
Colorado CyberknifeLafayette, Colorado  80026
New Millenium CyberKnifeBrandon, Florida  33511
JFK Comprehensive Cancer CenterLake Worth, Florida  33461
South Florida Radiation OncologyWellington, Florida  33449
Benefis Health System - Sletten Cancer InstituteGreat Falls, Montana  59405