Prostate Cancer Clinical Trial
Official title:
Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Verified date | May 2023 |
Source | Accuray Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Accuray Incorporated |
United States,
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. |
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