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Administrative reasons
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The primary purpose of this research is to describe patient characteristics predictive of an imaging study positive for distant metastases in patients with castration-resistant prostate cancer and no known distant metastases.
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease. | Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. |
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Inclusion Criteria:
Exclusion Criteria:
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Men with Castration-Resistant Prostate Cancerand no known M1 disease who are at least 18 years of age at the time of screening are eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Brown, MD | Dendreon Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Clinical Research Center, LLC | Anchorage | Alaska | 99503 | United States | ||
| Urological Associate of Southern Arizona |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sipuleucel-T | A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer |
| 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 | Aug 1, 2014 |
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Whole blood, serum
| Tucson |
| Arizona |
| United States |
| Sequoia Urology Center | Atherton | California | United States |
| Prostate Oncology Specialist, Inc. | Marina del Rey | California | 90292 | United States |
| Sutter Medical Group | Sacramento | California | United States |
| Genesis Research | San Diego | California | 92123 | United States |
| Urology Associates of San Luis Obispo | Templeton | California | 93465 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Advanced Urology, P.C | Parker | Colorado | 80134 | United States |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | United States |
| Urology Center of South Florida | Miami | Florida | United States |
| Idaho Urologic Institute | Meridian | Idaho | 83642 | United States |
| Comprehensive Urologic Care, SC | Lake Barrington | Illinois | 60010 | United States |
| Uro Partners/ RMD Clinical Research | Melrose Park | Illinois | 60160 | United States |
| Associated Urological Specialists, LLC | Palos Heights | Illinois | 60463 | United States |
| 1st Urology, PSC | Jeffersonville | Indiana | 47130 | United States |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | United States |
| Kansas City Urology Care, PA | Overland Park | Kansas | 66211 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Jewish Hospital | Louisville | Kentucky | 40245 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Highland Clinic | Shreveport | Louisiana | 71106 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Mid Atlantic Urology Associates | Greenbelt | Maryland | 20770 | United States |
| Chesapeake Urology Research Associates | Towson | Maryland | 21204 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| Metro Urology | Plymouth | Minnesota | 55441 | United States |
| Metro Urology | Woodbury | Minnesota | 55125 | United States |
| Saint Louis VAMS | St Louis | Missouri | United States |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | United States |
| Urology Center Research Institute | Englewood | New Jersey | 07631 | United States |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | 08054 | United States |
| National Translational Research Group | East Setauket | New York | United States |
| Integrated Medical Professionals, PLLC | North Hills | New York | 11042 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Durham Veterans Affairs Medical Center | Durham | North Carolina | 27710 | United States |
| Carolina Urology Partners | Gastonia | North Carolina | 28054 | United States |
| Central Ohio Urology Group | Gahanna | Ohio | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | United States |
| Stepherson Cancer Center | Oklahoma City | Oklahoma | United States |
| Portland Veterans Administration Medical Center | Portland | Oregon | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Urology Health Specialists, LLC | Bryn Mawr | Pennsylvania | 19010 | United States |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| The Conrad Pearson Clinic | Germantown | Tennessee | United States |
| Tennessee Urology Asociates | Knoxville | Tennessee | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Houston Metro Urology | Houston | Texas | 77027 | United States |
| UT Memorial Hermann Cancer Center | Houston | Texas | United States |
| Oncology San Antonio Research LLC | San Antonio | Texas | 78240 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23642 | United States |
| Medical Oncology Associates | Spokane | Washington | 99208 | United States |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sipuleucel-T | A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Height | Mean | Standard Deviation | Centemeters |
| |||||||||||||||||||
| Weight | Mean | Standard Deviation | Kg |
| |||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 | Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration | The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease. | There were 206 patients at baseline that had a valuable data that were assessed. The results were 151 patients that had non-metastatic (M0) and 55 patients that had metastatic disease (M1) disease. The study terminated early therefore no further statistical analysis was performed. | Posted | Mean | Standard Deviation | years | Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. |
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Adverse Events and Serious Adverse Events were not collected in this trial as investigational treatment was not administered in this study. Patients received commercial Provenge® (sipuleucel-T), therefore all SAEs were reported to the Safety Reporting group following full prescribing directions.
Adverse Events and Serious Adverse Events were not collected in this trial as investigational treatment was not administered in this study. Patients received commercial Provenge® (sipuleucel-T), therefore all SAEs were reported to the Safety Reporting group following full prescribing directions.
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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 | Sipuleucel-T | A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer | 0 | 0 | 0 | 0 | 0 | 0 |
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The study was designed to analyze 1200 patients. Early termination resulted in only 206 patients reporting a definitive diagnosis per imaging scan. Given this much smaller number of patients, the analyses do not provide reliable results.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Vaziri | Dendreon | 206.455.2323 | svaziri@Dendreon.com |
| Jan 15, 2019 |
| Prot_SAP_000.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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