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

Prostate Cancer Clinical Trial

Official title:

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643617
• Other study ID #: ACCP002.2
• Status: Completed
• Phase: N/A
• Start date: October 22, 2007
• Est. completion date: April 7, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• 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

• 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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• CyberKnife Stereotactic Radiosurgery - Low Risk
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate
• CyberKnife Stereotactic Radiosurgery - Intermediate Risk
38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally

Locations

Country	Name	City	State
United States	New Millenium CyberKnife	Brandon	Florida
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Penrose Cancer Center	Colorado Springs	Colorado
United States	AtlantiCare Regional Medical Center	Egg Harbor Township	New Jersey
United States	Elmhurst Memorial Hospital	Elmhurst	Illinois
United States	Community Regional Medical Center	Fresno	California
United States	Benefis Health System - Sletten Cancer Institute	Great Falls	Montana
United States	Colorado Cyberknife	Lafayette	Colorado
United States	JFK Comprehensive Cancer Center	Lake Worth	Florida
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Mitchell Cancer Center University of South Alabama	Mobile	Alabama
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	St. Anthony Hospital	Oklahoma City	Oklahoma
United States	Pasadena Cyberknife Center	Pasadena	California
United States	CyberKnife Centers of San Diego	San Diego	California
United States	East Texas Medical Center	Tyler	Texas
United States	South Florida Radiation Oncology	Wellington	Florida

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 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.	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 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.	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.	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	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.
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