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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heterogeneous Dose | Other | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery - Low Risk | Radiation | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 2 mm around the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald B Fuller, MD | CyberKnife Centers at San Diego, CA | Study Chair |
| George Mardirossian, PhD | CyberKnife Centers of San Diego, CA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mitchell Cancer Center University of South Alabama | Mobile | Alabama | 36604 | United States | ||
| Community Regional Medical Center |
Not provided
| Label | URL |
|---|---|
| Accuray Website | View source |
Not provided
Of these 307 subjects, 48 patients did not receive study treatment and were withdrawn from the study. Reasons for withdrawal included meeting exclusion criteria after central pathology review, insurance did not approve participation in a clinical study, or patient decision to withdraw prior to receiving treatment.
259 subjects were assigned to either the "Low Risk" or "Intermediate Risk" groups after central pathology review results.
From October 2007 through December 2011, 307 subjects signed informed consent and were enrolled in the study at 18 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Risk | Patients with clinical stage (CS) Tumor (T) 1b-T2a and Gleason 2-6 and Prostate specific Antigen (PSA) ≤ 10 ng/ml |
| FG001 | Intermediate Risk | Patients with CS T2b and Gleason 2-6 and PSA ≤ 10 ng/ml or CS T1b-T2b and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2012 |
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|
| CyberKnife Stereotactic Radiosurgery - Intermediate Risk | Radiation | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally |
|
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Fresno |
| California |
| 93721 |
| United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States |
| Pasadena Cyberknife Center | Pasadena | California | 91105 | United States |
| CyberKnife Centers of San Diego | San Diego | California | 92101 | United States |
| Penrose Cancer Center | Colorado Springs | Colorado | 80907 | United States |
| Colorado Cyberknife | Lafayette | Colorado | 80026 | United States |
| New Millenium CyberKnife | Brandon | Florida | 33511 | United States |
| JFK Comprehensive Cancer Center | Lake Worth | Florida | 33461 | United States |
| South Florida Radiation Oncology | Wellington | Florida | 33449 | United States |
| Elmhurst Memorial Hospital | Elmhurst | Illinois | 60126 | United States |
| Benefis Health System - Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| AtlantiCare Regional Medical Center | Egg Harbor | New Jersey | 08234 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| St. Anthony Hospital | Oklahoma City | Oklahoma | 73102 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| East Texas Medical Center | Tyler | Texas | 75701 | United States |
|
| 10-yr Follow up | Optional extension per protocol amendment |
|
| COMPLETED | Completed required 5-year follow up |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | CyberKnife Stereotactic Radiosurgery - Intermediate Risk | 38 Gy delivered in 4 fractions of 9.5 Gy per fraction with a radial margin of 5mm posterolaterally |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Tumor Clinical Stage (CS) | Clinical T category of prostate cancer, estimated by investigator at the time of patient screening. | Count of Participants | Participants |
| |||||||||||||||
| Total Gleason Score | The pathologist looking at the biopsy sample will assign one Gleason grade to the most predominant pattern in the biopsy and a second Gleason grade to the second most predominant pattern. The two grades will then be added together to determine the Gleason score. Gleason scores range from 2-10. Cancer cells that look similar to healthy cells receive a low score. Cancer cells that look less like healthy cells or look more aggressive receive a higher score. Patients with Gleason scores 2-6 are in the Low Risk Group. Patients with Gleason scores of 7 are in the Intermediate Risk Group. | Count of Participants | Participants |
| |||||||||||||||
| Prostate Specific Antigen (PSA) | Mean | Full Range | ng/mL |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). It was developed by the ECOG and published in 1982. | Count of Participants | Participants |
| |||||||||||||||
| American Joint Committee on Cancer (AJCC) 6th Edition Risk Group | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | 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. | Posted | Number | percentage of participants | 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. | Posted | Number | percentage of participants | 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 questionnaires were to be completed by patients for each follow-up visit. All questions need to be completed in order to calculate the score. During follow-up, patients may have withdrawn from the study, did not consent to continue follow-up through 10 years, were lost to follow-up, decided not to complete a questionnaire, or did not fully complete a questionnaire. Scores were calculated on fully completed questionnaires even if received/dated outside protocol specified visit window. | Posted | Mean | Standard Deviation | score on a scale | 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. | EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window. | Posted | Mean | Standard Deviation | score on a scale | 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. | EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window. | Posted | Mean | Standard Deviation | score on a scale | 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. | EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window. | Posted | Mean | Standard Deviation | score on a scale | 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. | EPIC questionnaires were completed by patients at follow-up visits. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window. | Posted | Mean | Standard Deviation | score on a scale | Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years. |
|
Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CK treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Risk | Patients with CS T1b-T2a and Gleason 2-6 and PSA ≤ 10 | 9 | 112 | 17 | 112 | 103 | 112 |
| EG001 | Intermediate Risk | Patients with 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 | 14 | 147 | 25 | 147 | 142 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrhythmia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac Ischemia/Infarction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiopulmonary Arrest | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Valvular Heart Disease | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| CNS Ischemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ischemic Colitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Obstruction (Small Bowel) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Other Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cervical Spine Stenosis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood Alteration | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Transverse Myelitis | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Plane crash | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aortic Atheroma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Kidney Transplant | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urgency | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Inflammation of the rectal lining |
|
| Hemorrhage/Bleeding - GI | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Rectal bleeding, blood in stool |
|
| GI Pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Pain reported in the abdomen, rectum (proctalgia) |
|
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Frequency/Urgency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Hesitancy, decreased force, difficulty during urination |
|
| Hemorrhage/Bleeding - GU | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Blood in urine (hematuria) |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - GU | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Painful urination (dysuria), pain in genitourinary region |
|
| Pain - Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment | Pain reported in bone, joint, back, shoulder, hip |
|
| Hematospermia | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment | Blood in sperm |
|
| Pain - Reproductive/Sexual | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment | Pain in prostate, testes, pelvis, pain on ejaculation |
|
| Ejaculatory Dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
|
A limitation of this study is that of the 18 sites originally enrolling eligible patients, only 7 opted to participate in the extension of follow-up through 10 years. However, from these 7 sites, 130 patients, out of the 151 total patients who completed 5-year follow-up, consented to continue follow-up beyond 5 years.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Accuray, Inc. | 608-824-3421 | sgodbold@accuray.com |
| Apr 3, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black/African American |
|
| Hispanic/Latino |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable |
|
| T2a = Tumor involves ½ of one side or less |
|
| T2b = Tumor involves >½ of one side but not both sides |
|
| Gleason 7 |
|
| 1 = Restricted in physically strenuous activity |
|
| 2 = Capable of all selfcare but unable to carry out any work activities |
|
| 3 = Capable of only limited selfcare |
|
| Unreported |
|
| Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml |
|
| Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml |
|
| Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml |
|
| Probability of experiencing Late GI Grade 3+ events 5 years post treatment |
|
| Probability of experiencing Late GU Grade 3+ events 5 years post treatment |
|
| Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment |
|
| Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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|
| Units | Counts |
|---|---|
| Participants |
|
|