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

Not Applicable

Completed

Conditions: Cancer of the Prostate
Prostatic Neoplasms
Prostatic Cancer
Prostate Cancer
Prostate Neoplasms

Interventions: Radiation: CyberKnife Stereotactic Radiosurgery

Registration Number: NCT00643994

Lead Sponsor: Accuray Incorporated

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 379

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CyberKnife Stereotactic Radiosurgery	CyberKnife Stereotactic Radiosurgery	36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.

Primary Outcome Measures

Name	Time	Method
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity	Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \[AE\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported. Adverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities. The rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment. The Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.
Biochemical Disease-Free Survival (bDFS)	Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.

Secondary Outcome Measures

Name	Time	Method
Disease Control and Survival Outcomes	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.
Quality of Life Assessments: EPIC-26 Sexual	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always). Total score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.
Quality of Life Assessments: EPIC-26 Bowel	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.	EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal. Answers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.

Trial Locations

Locations (23): The CyberKnife at Newport Diagnostic Center
🇺🇸
Newport Beach, California, United States
Northwest Community Hospital
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Arlington Heights, Illinois, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
Sinai Hospital of Baltimore
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Baltimore, Maryland, United States
Franklin Square Hospital Center
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Baltimore, Maryland, United States
Swedish Cancer Center
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Seattle, Washington, United States
ThedaCare Appleton Medical Center
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Appleton, Wisconsin, United States
Scripps Cancer Center - CyberKnife of Southern California at Vista
🇺🇸
La Jolla, California, United States
Georgetown University
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Washington, District of Columbia, United States
St. Mary's Regional Medical Center
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Reno, Nevada, United States
St. Joseph's Hospital and Medical Center
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Phoenix, Arizona, United States
Coastal CyberKnife and Radiation Oncology
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Fort Pierce, Florida, United States
Jupiter Medical Center & CyberKnife Center of Palm Beach
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Jupiter, Florida, United States
Community Cancer Center
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Normal, Illinois, United States
Central Baptist Hospital
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Lexington, Kentucky, United States
St. Joseph Mercy Hospital
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Ann Arbor, Michigan, United States
Lake Saint Louis Oncology
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Saint Louis, Missouri, United States
Saint Louis University
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Saint Louis, Missouri, United States
Hematology Oncology Associates of Central New York
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Syracuse, New York, United States
Virginia Hospital Center
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Arlington, Virginia, United States
Capital Health
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Trenton, New Jersey, United States
Southwest Washington Regional Cancer Center
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Vancouver, Washington, United States
Southwest Washington Medical Center
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Vancouver, Washington, United States