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

April 17, 2023 updated by: Accuray Incorporated

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • California
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center - CyberKnife of Southern California at Vista
      • Newport Beach, California, United States, 92660
        • The CyberKnife at Newport Diagnostic Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
    • Florida
      • Fort Pierce, Florida, United States, 34982
        • Coastal CyberKnife and Radiation Oncology
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center & CyberKnife Center of Palm Beach
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Community Hospital
      • Normal, Illinois, United States, 61761
        • Community Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Hospital Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63367
        • Lake Saint Louis Oncology
      • Saint Louis, Missouri, United States, 63367
        • Saint Louis University
    • Nevada
      • Reno, Nevada, United States, 89503
        • St. Mary's Regional Medical Center
    • New Jersey
      • Trenton, New Jersey, United States, 08618
        • Capital Health
    • New York
      • Syracuse, New York, United States, 15057
        • Hematology Oncology Associates of Central New York
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Virginia Hospital Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Cancer Center
      • Vancouver, Washington, United States, 98664
        • Southwest Washington Medical Center
      • Vancouver, Washington, United States, 98664
        • Southwest Washington Regional Cancer Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Appleton Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Names:
  • CyberKnife

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Time Frame: 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.
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)
Time Frame: 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.
Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Disease Control and Survival Outcomes
Time Frame: 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.
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)
Time Frame: 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
Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accuray Incorporated

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 27, 2021

Study Completion (Actual)

January 27, 2021

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCP001.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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