Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

NCT ID: NCT01981109

Last Updated: 2019-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Castration-Resistant Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dendreon

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Brown, MD

Role: STUDY_DIRECTOR

Dendreon Pharmaceuticals, LLC

Locations

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Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Site Status

Urological Associate of Southern Arizona

Tucson, Arizona, United States

Site Status

Sequoia Urology Center

Atherton, California, United States

Site Status

Prostate Oncology Specialist, Inc.

Marina del Rey, California, United States

Site Status

Sutter Medical Group

Sacramento, California, United States

Site Status

Genesis Research

San Diego, California, United States

Site Status

Urology Associates of San Luis Obispo

Templeton, California, United States

Site Status

The Urology Center of Colorado

Denver, Colorado, United States

Site Status

Advanced Urology, P.C

Parker, Colorado, United States

Site Status

Howard University Hospital

Washington D.C., District of Columbia, United States

Site Status

Urology Center of South Florida

Miami, Florida, United States

Site Status

Idaho Urologic Institute

Meridian, Idaho, United States

Site Status

Comprehensive Urologic Care, SC

Lake Barrington, Illinois, United States

Site Status

Uro Partners/ RMD Clinical Research

Melrose Park, Illinois, United States

Site Status

Associated Urological Specialists, LLC

Palos Heights, Illinois, United States

Site Status

1st Urology, PSC

Jeffersonville, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

Kansas City Urology Care, PA

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Highland Clinic

Shreveport, Louisiana, United States

Site Status

Regional Urology, LLC

Shreveport, Louisiana, United States

Site Status

Mid Atlantic Urology Associates

Greenbelt, Maryland, United States

Site Status

Chesapeake Urology Research Associates

Towson, Maryland, United States

Site Status

Michigan Institute of Urology

Troy, Michigan, United States

Site Status

Metro Urology

Plymouth, Minnesota, United States

Site Status

Metro Urology

Woodbury, Minnesota, United States

Site Status

Saint Louis VAMS

St Louis, Missouri, United States

Site Status

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

Site Status

Urology Center Research Institute

Englewood, New Jersey, United States

Site Status

Delaware Valley Urology, LLC

Mount Laurel, New Jersey, United States

Site Status

National Translational Research Group

East Setauket, New York, United States

Site Status

Integrated Medical Professionals, PLLC

North Hills, New York, United States

Site Status

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, United States

Site Status

Associated Medical Professionals of NY, PLLC

Syracuse, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Durham Veterans Affairs Medical Center

Durham, North Carolina, United States

Site Status

Carolina Urology Partners

Gastonia, North Carolina, United States

Site Status

Central Ohio Urology Group

Gahanna, Ohio, United States

Site Status

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Site Status

Stepherson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status

Portland Veterans Administration Medical Center

Portland, Oregon, United States

Site Status

Oregon Urology Institute

Springfield, Oregon, United States

Site Status

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, United States

Site Status

Urology Health Specialists, LLC

Bryn Mawr, Pennsylvania, United States

Site Status

Lancaster Urology

Lancaster, Pennsylvania, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

The Conrad Pearson Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Urology Asociates

Knoxville, Tennessee, United States

Site Status

Urology Associates, P.C.

Nashville, Tennessee, United States

Site Status

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status

Houston Metro Urology

Houston, Texas, United States

Site Status

UT Memorial Hermann Cancer Center

Houston, Texas, United States

Site Status

Oncology San Antonio Research LLC

San Antonio, Texas, United States

Site Status

Virginia Urology

Richmond, Virginia, United States

Site Status

Urology of Virginia, PLLC

Virginia Beach, Virginia, United States

Site Status

Medical Oncology Associates

Spokane, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P12-1

Identifier Type: -

Identifier Source: org_study_id

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