Clinical trial NCT00643994: CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Prostatic Cancer
Prostate Neoplasms
Prostatic Neoplasms
Cancer of the Prostate
Keywords: Prostate Cancer
CyberKnife
Stereotactic Radiosurgery
Radiotherapy
Radiation
Prostate Tumor
Prostate Surgery
Lead sponsor: Accuray Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 379
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 determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

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.

Eligibility criteria: 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: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (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
* Eastern Cooperative Oncology Group (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.

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: 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: 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: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: La Jolla
country: United States
facility: Scripps Cancer Center - CyberKnife of Southern California at Vista
state: California
city: Newport Beach
country: United States
facility: The CyberKnife at Newport Diagnostic Center
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Fort Pierce
country: United States
facility: Coastal CyberKnife and Radiation Oncology
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center & CyberKnife Center of Palm Beach
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Community Hospital
state: Illinois
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Lake Saint Louis Oncology
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Reno
country: United States
facility: St. Mary's Regional Medical Center
state: Nevada
city: Trenton
country: United States
facility: Capital Health
state: New Jersey
city: Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Center
state: Washington
city: Vancouver
country: United States
facility: Southwest Washington Medical Center
state: Washington
city: Vancouver
country: United States
facility: Southwest Washington Regional Cancer Center
state: Washington
city: Appleton
country: United States
facility: ThedaCare Appleton Medical Center
state: Wisconsin
Study officials:
affiliation: Swedish Cancer Center
name: Robert Meier, MD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Irving Kaplan, MD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Martin Sanda, MD
role: STUDY_CHAIR
References:
citation: Meier RM, Bloch DA, Cotrutz C, Beckman AC, Henning GT, Woodhouse SA, Williamson SK, Mohideen N, Dombrowski JJ, Hong RL, Brachman DG, Linson PW, Kaplan ID. Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):296-303. doi: 10.1016/j.ijrobp.2018.05.040. Epub 2018 Jun 1.