Castration-Resistant Prostate Cancer Clinical Trial
— PREDICTOfficial title:
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
| NCT number | NCT01981109 |
| Other study ID # | P12-1 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2012 |
| Est. completion date | July 2017 |
| Verified date | July 2019 |
| Source | Dendreon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 225 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Written informed consent obtained prior to the initiation of study procedures. - Men = 18 years of age. - Histologically documented prostatic adenocarcinoma. - History of Castration-Resistant Prostate Cancer. Exclusion Criteria: - Known M1 disease. - Undergone imaging study for metastatic prostate cancer = 3 months. - ECOG performance status = 3. - Known malignant pleural effusions or ascites. - Current or prior treatment with investigational therapy for M0 Castration-Resistant Prostate Cancer (Taxotere (docetaxel), Provenge® (sipuleucel-T), Zytiga (abiraterone acetate), Xtandi (enzalutamide), Jevtana (cabazitaxel), or Xofigo (radium Ra 223 dichloride). |
| Country | Name | City | State |
|---|---|---|---|
| United States | Alaska Clinical Research Center, LLC | Anchorage | Alaska |
| United States | Sequoia Urology Center | Atherton | California |
| United States | Urologic Consultants of SE PA | Bala-Cynwyd | Pennsylvania |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Urology Health Specialists, LLC | Bryn Mawr | Pennsylvania |
| United States | Urology Clinics of North Texas | Dallas | Texas |
| United States | The Urology Center of Colorado | Denver | Colorado |
| United States | Durham Veterans Affairs Medical Center | Durham | North Carolina |
| United States | National Translational Research Group | East Setauket | New York |
| United States | Urology Center Research Institute | Englewood | New Jersey |
| United States | Central Ohio Urology Group | Gahanna | Ohio |
| United States | Carolina Urology Partners | Gastonia | North Carolina |
| United States | The Conrad Pearson Clinic | Germantown | Tennessee |
| United States | Mid Atlantic Urology Associates | Greenbelt | Maryland |
| United States | Houston Metro Urology | Houston | Texas |
| United States | UT Memorial Hermann Cancer Center | Houston | Texas |
| United States | 1st Urology, PSC | Jeffersonville | Indiana |
| United States | Tennessee Urology Asociates | Knoxville | Tennessee |
| United States | Comprehensive Urologic Care, SC | Lake Barrington | Illinois |
| United States | Lancaster Urology | Lancaster | Pennsylvania |
| United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | Prostate Oncology Specialist, Inc. | Marina Del Rey | California |
| United States | Uro Partners/ RMD Clinical Research | Melrose Park | Illinois |
| United States | Idaho Urologic Institute | Meridian | Idaho |
| United States | Urology Center of South Florida | Miami | Florida |
| United States | Clinical Research Solutions | Middleburg Heights | Ohio |
| United States | Delaware Valley Urology, LLC | Mount Laurel | New Jersey |
| United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
| United States | Urology Associates, P.C. | Nashville | Tennessee |
| United States | Tulane University | New Orleans | Louisiana |
| United States | Integrated Medical Professionals, PLLC | North Hills | New York |
| United States | Stepherson Cancer Center | Oklahoma City | Oklahoma |
| United States | Kansas City Urology Care, PA | Overland Park | Kansas |
| United States | Associated Urological Specialists, LLC | Palos Heights | Illinois |
| United States | Advanced Urology, P.C | Parker | Colorado |
| United States | Metro Urology | Plymouth | Minnesota |
| United States | Portland Veterans Administration Medical Center | Portland | Oregon |
| United States | Premier Medical Group of the Hudson Valley | Poughkeepsie | New York |
| United States | Virginia Urology | Richmond | Virginia |
| United States | Sutter Medical Group | Sacramento | California |
| United States | Saint Louis VAMS | Saint Louis | Missouri |
| United States | Oncology San Antonio Research LLC | San Antonio | Texas |
| United States | Genesis Research | San Diego | California |
| United States | Highland Clinic | Shreveport | Louisiana |
| United States | Regional Urology, LLC | Shreveport | Louisiana |
| United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
| United States | Medical Oncology Associates | Spokane | Washington |
| United States | Oregon Urology Institute | Springfield | Oregon |
| United States | Associated Medical Professionals of NY, PLLC | Syracuse | New York |
| United States | Urology Associates of San Luis Obispo | Templeton | California |
| United States | Chesapeake Urology Research Associates | Towson | Maryland |
| United States | Michigan Institute of Urology | Troy | Michigan |
| United States | Urological Associate of Southern Arizona | Tucson | Arizona |
| United States | Urology of Virginia, PLLC | Virginia Beach | Virginia |
| United States | Howard University Hospital | Washington | District of Columbia |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | Metro Urology | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Dendreon |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. |
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