CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
1 other identifier
interventional
379
1 country
23
Brief Summary
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
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 Dec 2007
Longer than P75 for not_applicable prostate-cancer
23 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
December 1, 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
January 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2021
CompletedResults Posted
Study results publicly available
May 9, 2023
CompletedMay 9, 2023
April 1, 2023
13.2 years
March 20, 2008
February 3, 2023
April 17, 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 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 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.
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)
Secondary outcomes were measured at 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)
CyberKnife Stereotactic Radiosurgery
EXPERIMENTAL36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.
Interventions
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Scripps Cancer Center - CyberKnife of Southern California at Vista
La Jolla, California, 92037, United States
The CyberKnife at Newport Diagnostic Center
Newport Beach, California, 92660, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
Coastal CyberKnife and Radiation Oncology
Ft. Pierce, Florida, 34982, United States
Jupiter Medical Center & CyberKnife Center of Palm Beach
Jupiter, Florida, 33458, United States
Northwest Community Hospital
Arlington Heights, Illinois, 60005, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Lake Saint Louis Oncology
St Louis, Missouri, 63367, United States
Saint Louis University
St Louis, Missouri, 63367, United States
St. Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Capital Health
Trenton, New Jersey, 08618, United States
Hematology Oncology Associates of Central New York
Syracuse, New York, 15057, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
Swedish Cancer Center
Seattle, Washington, 98122, United States
Southwest Washington Medical Center
Vancouver, Washington, 98664, United States
Southwest Washington Regional Cancer Center
Vancouver, Washington, 98664, United States
ThedaCare Appleton Medical Center
Appleton, Wisconsin, 54911, United States
Related Publications (1)
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.
PMID: 30191864DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A limitation of this study is that of the 21 sites originally enrolling eligible patients, only 14 opted to continue beyond year 5. While 189 patients were followed through year 5, only 135 of these consented to continued follow-up. We also note that several patients were due for their 10-year follow-up during Coronavirus Disease (COVID) lockdowns, hampering study activities such as monitoring visits as well as patient compliance with protocol-required visit windows.
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- Accuray, Inc.
Study Officials
- STUDY CHAIR
Robert Meier, MD
Swedish Cancer Center
- STUDY CHAIR
Irving Kaplan, MD
Beth Israel Deaconess Medical Center
- STUDY CHAIR
Martin Sanda, MD
Beth Israel Deaconess Medical Center
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
December 1, 2007
Primary Completion
January 27, 2021
Study Completion
January 27, 2021
Last Updated
May 9, 2023
Results First Posted
May 9, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share