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

Primary Purpose

Prostate Cancer, Prostatic Cancer, Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Stereotactic Radiosurgery - Low Risk
CyberKnife Stereotactic Radiosurgery - Intermediate Risk
Sponsored by
Accuray Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Prostate Tumor, Prostate Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 T1b-T2b, N0, M0
  • Patients belonging to one of the following risk categories:
  • Low Risk: CS T1b-T2a, Gleason Score 2-6, 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
  • ECOG performance status 0-1

Exclusion Criteria:

  • Clinical Stage T2c or greater
  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy fo 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

Sites / Locations

  • Mitchell Cancer Center University of South Alabama
  • Community Regional Medical Center
  • Long Beach Memorial Medical Center
  • Pasadena Cyberknife Center
  • CyberKnife Centers of San Diego
  • Penrose Cancer Center
  • Colorado Cyberknife
  • New Millenium CyberKnife
  • JFK Comprehensive Cancer Center
  • South Florida Radiation Oncology
  • Elmhurst Memorial Hospital
  • Benefis Health System - Sletten Cancer Institute
  • Comprehensive Cancer Centers of Nevada
  • AtlantiCare Regional Medical Center
  • University of North Carolina
  • St. Anthony Hospital
  • Sarah Cannon Research Institute
  • East Texas Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Heterogeneous Dose

Arm Description

38 Gy delivered in 4 fractions of 9.5 Gy per fraction

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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.

Full Information

First Posted
March 20, 2008
Last Updated
May 5, 2023
Sponsor
Accuray Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00643617
Brief Title
CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Official Title
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2007 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
April 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accuray Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
Keywords
Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiosurgery, Prostate Tumor, Prostate Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heterogeneous Dose
Arm Type
Other
Arm Description
38 Gy delivered in 4 fractions of 9.5 Gy per fraction
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Stereotactic Radiosurgery - Low Risk
Other Intervention Name(s)
CyberKnife
Intervention Description
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Stereotactic Radiosurgery - Intermediate Risk
Other Intervention Name(s)
CyberKnife
Intervention Description
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally
Primary Outcome Measure Information:
Title
Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity
Description
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.
Title
Biochemical Disease-Free Survival (bDFS)
Description
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.
Secondary Outcome Measure Information:
Title
Disease Control and Survival Outcomes
Description
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.
Title
Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)
Description
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.
Title
Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence
Description
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.
Title
Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive
Description
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.
Title
Quality of Life Assessments: EPIC-26 Bowel
Description
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.
Title
Quality of Life Assessments: EPIC-26 Sexual
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald B Fuller, MD
Organizational Affiliation
CyberKnife Centers at San Diego, CA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George Mardirossian, PhD
Organizational Affiliation
CyberKnife Centers of San Diego, CA
Official's Role
Study Chair
Facility Information:
Facility Name
Mitchell Cancer Center University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pasadena Cyberknife Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
CyberKnife Centers of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Penrose Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Cyberknife
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
New Millenium CyberKnife
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
JFK Comprehensive Cancer Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
South Florida Radiation Oncology
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Elmhurst Memorial Hospital
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Facility Name
Benefis Health System - Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
St. Anthony Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.accuray.com
Description
Accuray Website

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

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