Clinical trial NCT00643617: CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostatic Cancer
Prostatic Neoplasms
Prostate Neoplasms
Cancer of the Prostate
Keywords: Prostate Cancer
CyberKnife
Stereotactic Radiosurgery
Radiosurgery
Prostate Tumor
Prostate Surgery
Lead sponsor: Accuray Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 307
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: In this study, CyberKnife radiosurgery will be used to produce dose distributions comparable to those created by High Dose Rate (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.

Eligibility criteria: 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 (CS) T1b-T2b, N0, M0
* Patients belonging to one of the following risk categories:
* Low Risk: CS T1b-T2a, Gleason Score 2-6, Prostate Specific Antigen (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
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Clinical Stage T2c or greater
* Prior prostatectomy or cryotherapy of the prostate
* Prior radiotherapy of 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

Primary outcomes:
measure: Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
timeFrame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Biochemical Disease-Free Survival (bDFS)
timeFrame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary outcomes:
measure: Disease Control and Survival Outcomes
timeFrame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
timeFrame: AUA questionnaire was completed at Baseline, CK Treatment, and post treatment at: 1 week, 1 month, 3 months, 6 months, and then biannually up to 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
timeFrame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
timeFrame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Quality of Life Assessments: EPIC-26 Bowel
timeFrame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
measure: Quality of Life Assessments: EPIC-26 Sexual
timeFrame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mitchell Cancer Center University of South Alabama
state: Alabama
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Pasadena
country: United States
facility: Pasadena Cyberknife Center
state: California
city: San Diego
country: United States
facility: CyberKnife Centers of San Diego
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Lafayette
country: United States
facility: Colorado Cyberknife
state: Colorado
city: Brandon
country: United States
facility: New Millenium CyberKnife
state: Florida
city: Lake Worth
country: United States
facility: JFK Comprehensive Cancer Center
state: Florida
city: Wellington
country: United States
facility: South Florida Radiation Oncology
state: Florida
city: Elmhurst
country: United States
facility: Elmhurst Memorial Hospital
state: Illinois
city: Great Falls
country: United States
facility: Benefis Health System - Sletten Cancer Institute
state: Montana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Egg Harbor Township
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Oklahoma City
country: United States
facility: St. Anthony Hospital
state: Oklahoma
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Tyler
country: United States
facility: East Texas Medical Center
state: Texas
Study officials:
affiliation: CyberKnife Centers at San Diego, CA
name: Donald B Fuller, MD
role: STUDY_CHAIR
affiliation: CyberKnife Centers of San Diego, CA
name: George Mardirossian, PhD
role: STUDY_CHAIR
References: