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The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.
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 |
|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Experimental | 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberKnife Stereotactic Radiosurgery | Radiation | 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction |
|
| 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 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 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. |
| 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. 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Meier, MD | Swedish Cancer Center | Study Chair |
| Irving Kaplan, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Martin Sanda, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Scripps Cancer Center - CyberKnife of Southern California at Vista |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30191864 | Derived | 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. |
| Label | URL |
|---|---|
| Accuray Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CyberKnife Stereotactic Radiosurgery | Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction |
| 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 | May 13, 2013 |
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| 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. |
| 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. |
| La Jolla |
| California |
| 92037 |
| United States |
| The CyberKnife at Newport Diagnostic Center | Newport Beach | California | 92660 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | United States |
| Coastal CyberKnife and Radiation Oncology | Ft. Pierce | Florida | 34982 | United States |
| Jupiter Medical Center & CyberKnife Center of Palm Beach | Jupiter | Florida | 33458 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Lake Saint Louis Oncology | St Louis | Missouri | 63367 | United States |
| Saint Louis University | St Louis | Missouri | 63367 | United States |
| St. Mary's Regional Medical Center | Reno | Nevada | 89503 | United States |
| Capital Health | Trenton | New Jersey | 08618 | United States |
| Hematology Oncology Associates of Central New York | Syracuse | New York | 15057 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| Swedish Cancer Center | Seattle | Washington | 98122 | United States |
| Southwest Washington Medical Center | Vancouver | Washington | 98664 | United States |
| Southwest Washington Regional Cancer Center | Vancouver | Washington | 98664 | United States |
| ThedaCare Appleton Medical Center | Appleton | Wisconsin | 54911 | United States |
|
| 10-yr Follow up | optional extension per protocol amendment |
|
| COMPLETED | Completed required 5-year follow up |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CyberKnife Stereotactic Radiosurgery | 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of CK treatment | Mean | Full Range | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Clinical Stage (Tumor) | Clinical T category of prostate cancer, estimated by investigator at the time of patient screening. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Total Gleason Score | The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 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 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 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. | 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. Kaplan Meier estimates for 5-yr and 10-yr are reported. | 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 completed by patients for milestone follow-up visits, with 306/310 patients completing a baseline questionnaire. All questions needed to be completed in order to calculate the score. 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: 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, with 300/310 patients completing a baseline questionnaire. 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, with 300/310 patients completing a baseline questionnaire. 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, with 300/310 patients completing a baseline questionnaire. 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, with 300/310 patients completing a baseline questionnaire. 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-CyberKnife treatment.
All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CyberKnife Stereotactic Radiosurgery | Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction | 21 | 310 | 34 | 310 | 302 | 310 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| car accident | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Conduction abnormality/ atrioventricular heart block | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiopulmonary arrest | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Valvular heart disease | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Disease progression NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/skin other - cancer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| GI - other - cancer | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Liver dysfunction/failure | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hepatobiliary/pancreas - other - cancer | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hepatobiliary/pancreas - other cirrhosis | Hepatobiliary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - heart endocarditis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| infection with unknown ANC | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Potassium serum -low | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/soft tissue - fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - other | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory - cancer | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary obstruction | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/GU - other - cancer | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Other malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| vessel-injury artery - aorta | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| GI - other, diverticulosis | Gastrointestinal 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 |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| GI Hemorrhage/Bleeding | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | rectal bleeding, blood in stool |
|
| GI Pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Abdominal pain, stomach pain, rectal pain |
|
| GU Pain | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Pain with urination (dysuria) |
|
| 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 |
| |
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| GU Hemorrhage/Bleeding | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Blood in urine (hematuria), GU hemorrhage |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Ejaculatory Dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Sexual/Reproductive Pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment | Groin/pelvic pain, pain with ejaculation |
|
A limitation of this study is that of the 21 sites originally enrolling eligible patients, only 14 opted to continue beyond year 5. While 189 patients were followed through year 5, only 135 of these consented to continued follow-up. We also note that several patients were due for their 10-year follow-up during Coronavirus Disease (COVID) lockdowns, hampering study activities such as monitoring visits as well as patient compliance with protocol-required visit windows.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Accuray, Inc. | 608-824-3421 | sgodbold@accuray.com |
| Feb 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
| Black/African American |
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| Hispanic/Latino |
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| Native Hawaiian or Other Pacific Islander |
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| White |
|
| Unknown |
|
| T2a = Tumor involves ½ of one side or less |
|
| T2b = Tumor involves >½ of one side but not both sides |
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|
|
| 2 = Capable of all selfcare but unable to carry out any work activities |
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| 3 = Capable of only limited selfcare |
|
| Unreported |
|
| 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 GU Grade 3+ events 5 years post treatment |
|
| Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment |
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| Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment |
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