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| Sponsor: | Accuray Incorporated |
|---|---|
| Information provided by: | Accuray Incorporated |
| ClinicalTrials.gov Identifier: | NCT00643994 |
Purpose
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Prostatic Cancer Prostate Neoplasms Prostatic Neoplasms Cancer of the Prostate |
Radiation: CyberKnife Stereotactic Radiosurgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution |
| Estimated Enrollment: | 298 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
Contacts and Locations| Contact: Joanne N Davis, PhD | 248-719-2998 | jdavis@accuray.com |
| Contact: Omar Dawood, MD, MPH | 408-789-4457 | odawood@accuray.com |
| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Terry Thomas 602-240-3383 tthomas@azoncology.com | |
| Principal Investigator: David Brachman, MD | |
| United States, California | |
| Scripps Cancer Center - CyberKnife of Southern California at Vista | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Debbie Deseno, RN, BSN 858-652-5465 deseno.debbie@scrippshealth.org | |
| Principal Investigator: Patrick W Linson, MD, MPH | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20057 | |
| Contact: Heather Hanscom Heather.N.Hanscom@georgetown.edu | |
| Principal Investigator: Sean Collins, MD | |
| United States, Florida | |
| Coastal CyberKnife and Radiation Oncology | Recruiting |
| Fort Pierce, Florida, United States, 34982 | |
| Contact: Scott Allen 772-293-0377 scottallen@coastalcyberknife.com | |
| Principal Investigator: William Crook, MD | |
| Jupiter Medical Center & CyberKnife Center of Palm Beach | Recruiting |
| Jupiter, Florida, United States, 33458 | |
| Contact: Janet Martin 561-745-5768 | |
| Principal Investigator: Eugene Shieh, MD | |
| United States, Illinois | |
| Northwest Community Hospital | Recruiting |
| Arlington Heights, Illinois, United States, 60005 | |
| Contact: Josie Smudde 847-618-6772 | |
| Principal Investigator: Najeeb Mohideen, MD | |
| Community Cancer Center | Recruiting |
| Normal, Illinois, United States, 61761 | |
| Contact: Sara Lindsey, MSN 309-451-2231 slindsey@cancercenter.org | |
| Principal Investigator: Don Stacy, MD | |
| United States, Kentucky | |
| Central Baptist Hospital | Recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact: Holly Weyl 859-260-6406 holly.weyl@bhsi.com | |
| Principal Investigator: Alan Beckman, MD | |
| United States, Maryland | |
| Franklin Square Hospital Center | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Cengiz Aygun, MD | |
| Contact: Linda Stark 410-682-6800 Linda.Stark@medstar.net | |
| Principal Investigator: Cengiz Aygun, MD | |
| Sinai Hospital of Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Jennifer Hertsch 410-601-9083 jhertsch@lifebridgehealth.org | |
| Principal Investigator: Mark Brenner, MD | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Courtney Collins, RN 617-667-4679 cacollin@bidmc.harvard.edu | |
| Principal Investigator: Irving Kaplan, MD | |
| United States, Michigan | |
| St. Joseph's Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Ann Novak 734-712-5674 | |
| Principal Investigator: George Henning, MD | |
| United States, Missouri | |
| Lake Saint Louis Oncology | Recruiting |
| Saint Louis, Missouri, United States, 63367 | |
| Contact: Patricia Tapella 314-577-8815 Tapellap@slu.edu | |
| Principal Investigator: Bruce J Walz, MD | |
| Saint Louis University | Recruiting |
| St. Louis, Missouri, United States, 63367 | |
| Contact: Patricia Tapella 314-577-8815 Tapellap@slu.edu | |
| Principal Investigator: Bruce Walz, MD | |
| United States, New Jersey | |
| Capital Health | Recruiting |
| Trenton, New Jersey, United States, 08618 | |
| Contact: Susan Wall 609-815-7443 | |
| Principal Investigator: Rachana Singh, MD | |
| United States, New York | |
| Hematology Oncology Associates of Central New York | Recruiting |
| Syracuse, New York, United States, 15057 | |
| Contact: Jeffrey Seeber, MS, DABR 315-472-7504 jseeber@Hoacny.com | |
| Principal Investigator: Dennis Kotlove, MD | |
| United States, Virginia | |
| Virginia Hospital Center | Recruiting |
| Arlington, Virginia, United States, 22205 | |
| Contact: Suzanne Milne, RN 703-558-6284 smilne@virginiahospitalcenter.com | |
| Principal Investigator: Robert L Hong, MD | |
| United States, Washington | |
| Swedish Cancer Center | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Justine Rees 206-386-6707 | |
| Principal Investigator: Robert Meier, MD | |
| Southwest Washington Medical Center | Recruiting |
| Vancouver, Washington, United States, 98664 | |
| Contact: Rebecca Hambright, RN 360-514-2155 rhambrig@swmedicalcenter.org | |
| Principal Investigator: Chris Hoffelt, MD | |
| United States, Wisconsin | |
| ThedaCare Appleton Medical Center | Recruiting |
| Appleton, Wisconsin, United States, 54911 | |
| Contact: Frances Taylortreder 920-831-5169 fran.taylortreder@thedacare.org | |
| Principal Investigator: Michael Ray, MD, PhD | |
| 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 |
More Information
| Responsible Party: | Accuray Incorporated ( Omar Dawood, Vice President of Clinical Development ) |
| Study ID Numbers: | ACCP001.2 |
| Study First Received: | March 20, 2008 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00643994 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Prostate Cancer CyberKnife Stereotactic Radiosurgery Radiotherapy |
Radiation Prostate Tumor Prostate Surgery |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
