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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE13807 | Other Identifier | Case Comprehensive Cancer Center |
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Prematurely terminated at institution request
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk).
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.
Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).
After completion of study therapy, patients are followed for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyberKnife® stereotactic radiosurgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 | This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment. | Within 90 days of completing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0 | Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions. | Within 5 years of completing treatment |
| Biochemical Disease-free Survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Disease confirmed by biopsy within 1 year of study entry
Gleason score 2-7(3+4)
Clinical stage T1a or T2b, N0 or NX, M0 or MX
T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)
M-stage determined by physical exam, CT scan, and/or MRI
PSA ≤ 10 ng/mL within the past 60 days
At risk for recurrence, as defined by 1 of the following risk groups:
Low-risk, defined by the following combination:
Low- to-Intermediate-risk, defined by either of the following combinations:
Prostate volume must be ≤ 100 cc
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Lee E. Ponsky, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CyberKnife® Stereotactic Radiosurgery | questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). implanted fiducial-based imaging: Undergo fiducial placement imaging stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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| ID | Title | Description |
|---|---|---|
| BG000 | CyberKnife® Stereotactic Radiosurgery | questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). implanted fiducial-based imaging: Undergo fiducial placement imaging stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | Number of Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 | This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment. | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Within 90 days of completing treatment |
|
The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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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 | questionnaire administration: Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms). implanted fiducial-based imaging: Undergo fiducial placement imaging stereotactic radiosurgery: Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. |
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The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Ponsky | Case Comprehensive Cancer Center | 216-844-4831 | lee.ponsky@uhhospitals.org |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| implanted fiducial-based imaging | Procedure | Undergo fiducial placement imaging |
|
| stereotactic radiosurgery | Radiation | Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days. |
|
PSA |
| Assessed at months 3,6,12,18,24 and every 6 months through 5 years |
| Disease-free Survival (Phoenix and ASTRO Definitions) | Assessed yearly for 5 years |
| Disease-specific Survival | Assessed yearly for 5 years |
| Overall Survival | Assessed yearly for 5 years |
| Rate of Local Failure | Assessed at months 3,6,12,18,24 and every 12 months through 5 years |
| Rate of Distant Failure | Assessed at months 3,6,12,18,24 and every 12 months through 5 years |
| Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices | Survey at 1,6,12 months and yearly up to 5 years |
| University Suburban Health Center | Cleveland | Ohio | 44121 | United States |
| UHHS Chagrin Highlands Medical Center | Cleveland | Ohio | 44122 | United States |
| UH-Westlake | Westlake | Ohio | 44145 | United States |
| years |
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
|
| Secondary | Number of Late Grade 3-5 Toxicities as Assessed by NCI CTCAE v3.0 | Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions. | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Within 5 years of completing treatment |
|
|
| Secondary | Biochemical Disease-free Survival | PSA | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed at months 3,6,12,18,24 and every 6 months through 5 years |
|
|
| Secondary | Disease-free Survival (Phoenix and ASTRO Definitions) | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed yearly for 5 years |
|
|
| Secondary | Disease-specific Survival | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed yearly for 5 years |
|
|
| Secondary | Overall Survival | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed yearly for 5 years |
|
|
| Secondary | Rate of Local Failure | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed at months 3,6,12,18,24 and every 12 months through 5 years |
|
|
| Secondary | Rate of Distant Failure | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Assessed at months 3,6,12,18,24 and every 12 months through 5 years |
|
|
| Secondary | Quality of Life as Measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices | The study was terminated prematurely by the IRB due to compliance issues. As per the IRB determination, data are not accessible to the study team for reporting. | Posted | Survey at 1,6,12 months and yearly up to 5 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |