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

Not Applicable

Completed

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

Interventions: Radiation: CyberKnife Stereotactic Radiosurgery - Low Risk
Radiation: CyberKnife Stereotactic Radiosurgery - Intermediate Risk

Registration Number: NCT00643617

Lead Sponsor: Accuray Incorporated

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 307

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heterogeneous Dose	CyberKnife Stereotactic Radiosurgery - Low Risk	38 Gy delivered in 4 fractions of 9.5 Gy per fraction
Heterogeneous Dose	CyberKnife Stereotactic Radiosurgery - Intermediate Risk	38 Gy delivered in 4 fractions of 9.5 Gy per fraction

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 in both low-risk and intermediate-risk cohorts 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 survival curves for bDFS were created and the 5-yr and 10-yr percentages are reported. The Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patients 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
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)	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.	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: 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.
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.
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: 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.
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.

Trial Locations

Locations (18): CyberKnife Centers of San Diego
🇺🇸
San Diego, California, United States
Sarah Cannon Research Institute
🇺🇸
Nashville, Tennessee, United States
Benefis Health System - Sletten Cancer Institute
🇺🇸
Great Falls, Montana, United States
Mitchell Cancer Center University of South Alabama
🇺🇸
Mobile, Alabama, United States
Long Beach Memorial Medical Center
🇺🇸
Long Beach, California, United States
Pasadena Cyberknife Center
🇺🇸
Pasadena, California, United States
Penrose Cancer Center
🇺🇸
Colorado Springs, Colorado, United States
Colorado Cyberknife
🇺🇸
Lafayette, Colorado, United States
New Millenium CyberKnife
🇺🇸
Brandon, Florida, United States
JFK Comprehensive Cancer Center
🇺🇸
Lake Worth, Florida, United States
Comprehensive Cancer Centers of Nevada
🇺🇸
Las Vegas, Nevada, United States
Elmhurst Memorial Hospital
🇺🇸
Elmhurst, Illinois, United States
AtlantiCare Regional Medical Center
🇺🇸
Egg Harbor Township, New Jersey, United States
South Florida Radiation Oncology
🇺🇸
Wellington, Florida, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States
St. Anthony Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
East Texas Medical Center
🇺🇸
Tyler, Texas, United States
Community Regional Medical Center
🇺🇸
Fresno, California, United States