CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
1 other identifier
interventional
307
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Oct 2007
Longer than P75 for not_applicable prostate-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2022
CompletedResults Posted
Study results publicly available
May 9, 2023
CompletedMay 9, 2023
May 1, 2023
14.5 years
March 20, 2008
April 3, 2023
May 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary Outcomes (6)
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.
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.
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.
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.
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.
- +1 more secondary outcomes
Study Arms (1)
Heterogeneous Dose
OTHER38 Gy delivered in 4 fractions of 9.5 Gy per fraction
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Mitchell Cancer Center University of South Alabama
Mobile, Alabama, 36604, United States
Community Regional Medical Center
Fresno, California, 93721, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Pasadena Cyberknife Center
Pasadena, California, 91105, United States
CyberKnife Centers of San Diego
San Diego, California, 92101, United States
Penrose Cancer Center
Colorado Springs, Colorado, 80907, United States
Colorado Cyberknife
Lafayette, Colorado, 80026, United States
New Millenium CyberKnife
Brandon, Florida, 33511, United States
JFK Comprehensive Cancer Center
Lake Worth, Florida, 33461, United States
South Florida Radiation Oncology
Wellington, Florida, 33449, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Benefis Health System - Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
AtlantiCare Regional Medical Center
Egg Harbor, New Jersey, 08234, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
St. Anthony Hospital
Oklahoma City, Oklahoma, 73102, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A limitation of this study is that of the 18 sites originally enrolling eligible patients, only 7 opted to participate in the extension of follow-up through 10 years. However, from these 7 sites, 130 patients, out of the 151 total patients who completed 5-year follow-up, consented to continue follow-up beyond 5 years.
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- Accuray, Inc.
Study Officials
- STUDY CHAIR
Donald B Fuller, MD
CyberKnife Centers at San Diego, CA
- STUDY CHAIR
George Mardirossian, PhD
CyberKnife Centers of San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 26, 2008
Study Start
October 22, 2007
Primary Completion
April 7, 2022
Study Completion
April 7, 2022
Last Updated
May 9, 2023
Results First Posted
May 9, 2023
Record last verified: 2023-05