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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643994
• Other study ID #: ACCP001.4
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: January 27, 2021

Study information

• Verified date: April 2023
• Source: Accuray Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Prostate
• Neoplasms
• Prostate Cancer
• Prostate Neoplasms
• Prostatic Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

Locations

Country	Name	City	State
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	ThedaCare Appleton Medical Center	Appleton	Wisconsin
United States	Virginia Hospital Center	Arlington	Virginia
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Coastal CyberKnife and Radiation Oncology	Fort Pierce	Florida
United States	Jupiter Medical Center & CyberKnife Center of Palm Beach	Jupiter	Florida
United States	Scripps Cancer Center - CyberKnife of Southern California at Vista	La Jolla	California
United States	Central Baptist Hospital	Lexington	Kentucky
United States	The CyberKnife at Newport Diagnostic Center	Newport Beach	California
United States	Community Cancer Center	Normal	Illinois
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	St. Mary's Regional Medical Center	Reno	Nevada
United States	Lake Saint Louis Oncology	Saint Louis	Missouri
United States	Saint Louis University	Saint Louis	Missouri
United States	Swedish Cancer Center	Seattle	Washington
United States	Hematology Oncology Associates of Central New York	Syracuse	New York
United States	Capital Health	Trenton	New Jersey
United States	Southwest Washington Medical Center	Vancouver	Washington
United States	Southwest Washington Regional Cancer Center	Vancouver	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Accuray Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary	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	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary	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.	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary	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.	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary	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.	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.
Secondary	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.	Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.

External Links

•   Accuray Website