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

July 24, 2019 updated by: Dendreon

A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Clinical Research Center, LLC
    • Arizona
      • Tucson, Arizona, United States
        • Urological Associate of Southern Arizona
    • California
      • Atherton, California, United States
        • Sequoia Urology Center
      • Marina Del Rey, California, United States, 90292
        • Prostate Oncology Specialist, Inc.
      • Sacramento, California, United States
        • Sutter Medical Group
      • San Diego, California, United States, 92123
        • Genesis Research
      • Templeton, California, United States, 93465
        • Urology Associates Of San Luis Obispo
    • Colorado
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
      • Parker, Colorado, United States, 80134
        • Advanced Urology, P.C
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
    • Florida
      • Miami, Florida, United States
        • Urology Center of South Florida
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Comprehensive Urologic Care, SC
      • Melrose Park, Illinois, United States, 60160
        • Uro Partners/ RMD Clinical Research
      • Palos Heights, Illinois, United States, 60463
        • Associated Urological Specialists, LLC
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • 1st Urology, PSC
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Urology Care, PA
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, United States, 40245
        • Jewish Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
      • Shreveport, Louisiana, United States, 71106
        • Regional Urology, LLC
      • Shreveport, Louisiana, United States, 71106
        • Highland Clinic
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Mid Atlantic Urology Associates
      • Towson, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Metro Urology
      • Woodbury, Minnesota, United States, 55125
        • Metro Urology
    • Missouri
      • Saint Louis, Missouri, United States
        • Saint Louis VAMS
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Urology Center Research Institute
      • Mount Laurel, New Jersey, United States, 08054
        • Delaware Valley Urology, LLC
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • East Setauket, New York, United States
        • National Translational Research Group
      • North Hills, New York, United States, 11042
        • Integrated Medical Professionals, PLLC
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of NY, PLLC
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Durham Veterans Affairs Medical Center
      • Gastonia, North Carolina, United States, 28054
        • Carolina Urology Partners
    • Ohio
      • Gahanna, Ohio, United States
        • Central Ohio Urology Group
      • Middleburg Heights, Ohio, United States
        • Clinical Research Solutions
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Stepherson Cancer Center
    • Oregon
      • Portland, Oregon, United States
        • Portland Veterans Administration Medical Center
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Institute
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of SE PA
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Urology Health Specialists, LLC
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster Urology
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Germantown, Tennessee, United States
        • The Conrad Pearson Clinic
      • Knoxville, Tennessee, United States
        • Tennessee Urology Asociates
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, P.C.
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • Houston, Texas, United States
        • UT Memorial Hermann Cancer Center
      • San Antonio, Texas, United States, 78240
        • Oncology San Antonio Research LLC
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology
      • Virginia Beach, Virginia, United States, 23642
        • Urology of Virginia, PLLC
    • Washington
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
Time Frame: 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.
Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Investigators

  • Study Director: Bruce Brown, MD, Dendreon Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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