Clinical trial NCT01981109: Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Official title: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Castration-Resistant Prostate Cancer
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 225
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
timeFrame: Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Tucson
country: United States
facility: Urological Associate of Southern Arizona
state: Arizona
city: Atherton
country: United States
facility: Sequoia Urology Center
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialist, Inc.
state: California
city: Sacramento
country: United States
facility: Sutter Medical Group
state: California
city: San Diego
country: United States
facility: Genesis Research
state: California
city: Templeton
country: United States
facility: Urology Associates of San Luis Obispo
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Parker
country: United States
facility: Advanced Urology, P.C
state: Colorado
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Urology Center of South Florida
state: Florida
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care, SC
state: Illinois
city: Melrose Park
country: United States
facility: Uro Partners/ RMD Clinical Research
state: Illinois
city: Palos Heights
country: United States
facility: Associated Urological Specialists, LLC
state: Illinois
city: Jeffersonville
country: United States
facility: 1st Urology, PSC
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Urology Care, PA
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Greenbelt
country: United States
facility: Mid Atlantic Urology Associates
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Plymouth
country: United States
facility: Metro Urology
state: Minnesota
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis VAMS
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Englewood
country: United States
facility: Urology Center Research Institute
state: New Jersey
city: Mount Laurel
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: East Setauket
country: United States
facility: National Translational Research Group
state: New York
city: North Hills
country: United States
facility: Integrated Medical Professionals, PLLC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Durham
country: United States
facility: Durham Veterans Affairs Medical Center
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Oklahoma City
country: United States
facility: Stepherson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Portland Veterans Administration Medical Center
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Urology Health Specialists, LLC
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Urology Asociates
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: Houston
country: United States
facility: UT Memorial Hermann Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Oncology San Antonio Research LLC
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
Study officials:
affiliation: Dendreon Pharmaceuticals, LLC
name: Bruce Brown, MD
role: STUDY_DIRECTOR
References: