CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

Sponsor

Accuray Incorporated (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00643994

Collaborator

(none)

309

Enrollment

Locations

Arm

169

Duration (Months)

13.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostatic Cancer Prostate Neoplasms Prostatic Neoplasms Cancer of the Prostate	Radiation: CyberKnife Stereotactic Radiosurgery	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

309 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2007

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CyberKnife Stereotactic Radiosurgery	Radiation: CyberKnife Stereotactic Radiosurgery 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction Other Names: CyberKnife

Arm

Intervention/Treatment

Experimental: CyberKnife Stereotactic Radiosurgery

Radiation: CyberKnife Stereotactic Radiosurgery

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

Other Names:

CyberKnife

Outcome Measures

Primary Outcome Measures

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. [10 years]
To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix and ASTRO definitions, following CyberKnife treatment. [10 years]

Secondary Outcome Measures

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. [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital and Medical Center	Phoenix	Arizona	United States	85013
2	Scripps Cancer Center - CyberKnife of Southern California at Vista	La Jolla	California	United States	92037
3	The CyberKnife at Newport Diagnostic Center	Newport Beach	California	United States	92660
4	Georgetown University	Washington	District of Columbia	United States	20057
5	Coastal CyberKnife and Radiation Oncology	Fort Pierce	Florida	United States	34982
6	Jupiter Medical Center & CyberKnife Center of Palm Beach	Jupiter	Florida	United States	33458
7	Northwest Community Hospital	Arlington Heights	Illinois	United States	60005
8	Community Cancer Center	Normal	Illinois	United States	61761
9	Central Baptist Hospital	Lexington	Kentucky	United States	40503
10	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
11	Franklin Square Hospital Center	Baltimore	Maryland	United States	21237
12	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
13	St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
14	Lake Saint Louis Oncology	Saint Louis	Missouri	United States	63367
15	Saint Louis University	Saint Louis	Missouri	United States	63367
16	St. Mary's Regional Medical Center	Reno	Nevada	United States	89503
17	Capital Health	Trenton	New Jersey	United States	08618
18	Hematology Oncology Associates of Central New York	Syracuse	New York	United States	15057
19	Virginia Hospital Center	Arlington	Virginia	United States	22205
20	Swedish Cancer Center	Seattle	Washington	United States	98122
21	Southwest Washington Medical Center	Vancouver	Washington	United States	98664
22	Southwest Washington Regional Cancer Center	Vancouver	Washington	United States	98664
23	ThedaCare Appleton Medical Center	Appleton	Wisconsin	United States	54911