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

NCT01981109 | Terminated Results

• 1 other identifier: P12-1
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 58

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.

Conditions

Castration-Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dendreon: lead

Study Sites (58)

Alaska Clinical Research Center, LLC

Anchorage, Alaska, 99503, United States

Location

Urological Associate of Southern Arizona

Tucson, Arizona, United States

Location

Sequoia Urology Center

Atherton, California, United States

Location

Prostate Oncology Specialist, Inc.

Marina del Rey, California, 90292, United States

Location

Sutter Medical Group

Sacramento, California, United States

Location

Genesis Research

San Diego, California, 92123, United States

Location

Urology Associates of San Luis Obispo

Templeton, California, 93465, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Advanced Urology, P.C

Parker, Colorado, 80134, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Urology Center of South Florida

Miami, Florida, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

Comprehensive Urologic Care, SC

Lake Barrington, Illinois, 60010, United States

Location

Uro Partners/ RMD Clinical Research

Melrose Park, Illinois, 60160, United States

Location

Associated Urological Specialists, LLC

Palos Heights, Illinois, 60463, United States

Location

1st Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States

Location

Kansas City Urology Care, PA

Overland Park, Kansas, 66211, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Jewish Hospital

Louisville, Kentucky, 40245, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Highland Clinic

Shreveport, Louisiana, 71106, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Mid Atlantic Urology Associates

Greenbelt, Maryland, 20770, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

Metro Urology

Plymouth, Minnesota, 55441, United States

Location

Metro Urology

Woodbury, Minnesota, 55125, United States

Location

Saint Louis VAMS

St Louis, Missouri, United States

Location

Southeast Nebraska Cancer Center

Lincoln, Nebraska, 68510, United States

Location

Urology Center Research Institute

Englewood, New Jersey, 07631, United States

Location

Delaware Valley Urology, LLC

Mount Laurel, New Jersey, 08054, United States

Location

National Translational Research Group

East Setauket, New York, United States

Location

Integrated Medical Professionals, PLLC

North Hills, New York, 11042, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Associated Medical Professionals of NY, PLLC

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Durham Veterans Affairs Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Urology Partners

Gastonia, North Carolina, 28054, United States

Location

Central Ohio Urology Group

Gahanna, Ohio, United States

Location

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Location

Stepherson Cancer Center

Oklahoma City, Oklahoma, United States

Location

Portland Veterans Administration Medical Center

Portland, Oregon, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Urology Health Specialists, LLC

Bryn Mawr, Pennsylvania, 19010, United States

Location

Lancaster Urology

Lancaster, Pennsylvania, 17604, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

The Conrad Pearson Clinic

Germantown, Tennessee, United States

Location

Tennessee Urology Asociates

Knoxville, Tennessee, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

UT Memorial Hermann Cancer Center

Houston, Texas, United States

Location

Oncology San Antonio Research LLC

San Antonio, Texas, 78240, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23642, United States

Location

Medical Oncology Associates

Spokane, Washington, 99208, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

Limitations and Caveats

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.

Results Point of Contact

• Title: Shabnam Vaziri
• Organization: Dendreon

svaziri@Dendreon.com

206.455.2323

Study Officials

• Bruce Brown, MD

  Dendreon Pharmaceuticals, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-07

Locations

US (58)