Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
- Conditions
- Castration-Resistant Prostate Cancer
- Registration Number
- NCT01981109
- Lead Sponsor
- Dendreon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 225
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (57)
Prostate Oncology Specialist, Inc.
🇺🇸Marina Del Rey, California, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Sutter Medical Group
🇺🇸Sacramento, California, United States
Urological Associate of Southern Arizona
🇺🇸Tucson, Arizona, United States
Sequoia Urology Center
🇺🇸Atherton, California, United States
Advanced Urology, P.C
🇺🇸Parker, Colorado, United States
Urology Associates of San Luis Obispo
🇺🇸Templeton, California, United States
Howard University Hospital
🇺🇸Washington, District of Columbia, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Associated Urological Specialists, LLC
🇺🇸Palos Heights, Illinois, United States
Comprehensive Urologic Care, SC
🇺🇸Lake Barrington, Illinois, United States
Uro Partners/ RMD Clinical Research
🇺🇸Melrose Park, Illinois, United States
1st Urology, PSC
🇺🇸Jeffersonville, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Kansas City Urology Care, PA
🇺🇸Overland Park, Kansas, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Highland Clinic
🇺🇸Shreveport, Louisiana, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Metro Urology
🇺🇸Woodbury, Minnesota, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Regional Urology, LLC
🇺🇸Shreveport, Louisiana, United States
Mid Atlantic Urology Associates
🇺🇸Greenbelt, Maryland, United States
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, United States
Saint Louis VAMS
🇺🇸Saint Louis, Missouri, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Urology Center Research Institute
🇺🇸Englewood, New Jersey, United States
Delaware Valley Urology, LLC
🇺🇸Mount Laurel, New Jersey, United States
National Translational Research Group
🇺🇸East Setauket, New York, United States
Integrated Medical Professionals, PLLC
🇺🇸North Hills, New York, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Associated Medical Professionals of NY, PLLC
🇺🇸Syracuse, New York, United States
Tennessee Urology Asociates
🇺🇸Knoxville, Tennessee, United States
Carolina Urology Partners
🇺🇸Gastonia, North Carolina, United States
The Conrad Pearson Clinic
🇺🇸Germantown, Tennessee, United States
Central Ohio Urology Group
🇺🇸Gahanna, Ohio, United States
Urologic Consultants of SE PA
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Clinical Research Solutions
🇺🇸Middleburg Heights, Ohio, United States
Urology Health Specialists, LLC
🇺🇸Bryn Mawr, Pennsylvania, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Lancaster Urology
🇺🇸Lancaster, Pennsylvania, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Oncology San Antonio Research LLC
🇺🇸San Antonio, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Medical Oncology Associates
🇺🇸Spokane, Washington, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
Genesis Research
🇺🇸San Diego, California, United States
Urology Center of South Florida
🇺🇸Miami, Florida, United States
Durham Veterans Affairs Medical Center
🇺🇸Durham, North Carolina, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
UT Memorial Hermann Cancer Center
🇺🇸Houston, Texas, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Stepherson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Portland Veterans Administration Medical Center
🇺🇸Portland, Oregon, United States
Urology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States