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

Primary Purpose

Prostate Cancer, Prostatic Cancer, Prostate Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Stereotactic Radiosurgery
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, Radiotherapy, Radiation, 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
  • Patients belonging in one of the following risk groups:

Low: CS T1b-T2a and Gleason 2-6 and 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
  • 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.

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Scripps Cancer Center - CyberKnife of Southern California at Vista
  • The CyberKnife at Newport Diagnostic Center
  • Georgetown University
  • Coastal CyberKnife and Radiation Oncology
  • Jupiter Medical Center & CyberKnife Center of Palm Beach
  • Northwest Community Hospital
  • Community Cancer Center
  • Central Baptist Hospital
  • Sinai Hospital of Baltimore
  • Franklin Square Hospital Center
  • Beth Israel Deaconess Medical Center
  • St. Joseph Mercy Hospital
  • Lake Saint Louis Oncology
  • Saint Louis University
  • St. Mary's Regional Medical Center
  • Capital Health
  • Hematology Oncology Associates of Central New York
  • Virginia Hospital Center
  • Swedish Cancer Center
  • Southwest Washington Medical Center
  • Southwest Washington Regional Cancer Center
  • ThedaCare Appleton Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyberKnife Stereotactic Radiosurgery

Arm Description

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.

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 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 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.

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. Kaplan Meier estimates for 5-yr and 10-yr are reported.
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
April 17, 2023
Sponsor
Accuray Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00643994
Brief Title
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
Official Title
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (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 determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Keywords
Prostate Cancer, CyberKnife, Stereotactic Radiosurgery, Radiotherapy, Radiation, 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
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyberKnife Stereotactic Radiosurgery
Arm Type
Experimental
Arm Description
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Stereotactic Radiosurgery
Other Intervention Name(s)
CyberKnife
Intervention Description
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
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 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 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.
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. Kaplan Meier estimates for 5-yr and 10-yr are reported.
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
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Meier, MD
Organizational Affiliation
Swedish Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Irving Kaplan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Sanda, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Scripps Cancer Center - CyberKnife of Southern California at Vista
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
The CyberKnife at Newport Diagnostic Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Coastal CyberKnife and Radiation Oncology
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Jupiter Medical Center & CyberKnife Center of Palm Beach
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Northwest Community Hospital
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Lake Saint Louis Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63367
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63367
Country
United States
Facility Name
St. Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Capital Health
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
Hematology Oncology Associates of Central New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
15057
Country
United States
Facility Name
Virginia Hospital Center
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Swedish Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Southwest Washington Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Southwest Washington Regional Cancer Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
ThedaCare Appleton Medical Center
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54911
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30191864
Citation
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.
Results Reference
derived
Links:
URL
http://www.accuray.com
Description
Accuray Website

Learn more about this trial

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

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