CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Sponsor

Accuray Incorporated (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00643617

Collaborator

(none)

253

Enrollment

Locations

Arm

175

Anticipated Duration (Months)

14.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

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

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

253 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: Emulating HDR Brachytherapy Dosimetry

Actual Study Start Date :

Nov 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Heterogeneous dose 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with CyberKnife Stereotactic Radiosurgery	Radiation: CyberKnife Stereotactic Radiosurgery 38 Gy delivered in 4 fractions of 9.5 Gy per fraction Other Names: CyberKnife

Arm

Intervention/Treatment

Other: Heterogeneous dose

38 Gy delivered in 4 fractions of 9.5 Gy per fraction with CyberKnife Stereotactic Radiosurgery

Radiation: CyberKnife Stereotactic Radiosurgery

38 Gy delivered in 4 fractions of 9.5 Gy per fraction

Other Names:

CyberKnife

Outcome Measures

Primary Outcome Measures

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. [10 years]
To compare the CyberKnife biochemical disease free survival rates (bDFS) to published HDR monotherapy bDFS rates reported in the literature. [10 years]

Secondary Outcome Measures

To measure the rates of local failure, distant failure, clinical-disease free survival, disease-specific survival, overall survival and quality of life. [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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mitchell Cancer Center University of South Alabama	Mobile	Alabama	United States	36604
2	Community Regional Medical Center	Fresno	California	United States	93721
3	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
4	Pasadena Cyberknife Center	Pasadena	California	United States	91105
5	CyberKnife Centers of San Diego	San Diego	California	United States	92101
6	Penrose Cancer Center	Colorado Springs	Colorado	United States	80907
7	Colorado Cyberknife	Lafayette	Colorado	United States	80026
8	New Millenium CyberKnife	Brandon	Florida	United States	33511
9	JFK Comprehensive Cancer Center	Lake Worth	Florida	United States	33461
10	South Florida Radiation Oncology	Wellington	Florida	United States	33449
11	Elmhurst Memorial Hospital	Elmhurst	Illinois	United States	60126
12	Benefis Health System - Sletten Cancer Institute	Great Falls	Montana	United States	59405
13	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89128
14	AtlantiCare Regional Medical Center	Egg Harbor Township	New Jersey	United States	08234
15	University of North Carolina	Chapel Hill	North Carolina	United States	27599
16	St. Anthony Hospital	Oklahoma City	Oklahoma	United States	73102
17	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
18	East Texas Medical Center	Tyler	Texas	United States	75701