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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
307
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, United States
Community Regional Medical Center
Fresno, California, United States
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
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.
Time frame: Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Biochemical Disease-Free Survival (bDFS)
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.
Time frame: Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Disease Control and Survival Outcomes
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.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
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Long Beach Memorial Medical Center
Long Beach, California, United States
Pasadena Cyberknife Center
Pasadena, California, United States
CyberKnife Centers of San Diego
San Diego, 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
South Florida Radiation Oncology
Wellington, Florida, United States
...and 8 more locations
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
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
Time frame: 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.
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
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.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
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.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Bowel
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.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Quality of Life Assessments: EPIC-26 Sexual
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.
Time frame: Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.