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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01981109
Recruitment Status : Terminated (Administrative reasons)
First Posted : November 11, 2013
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Description
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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.

Condition or disease
Castration-Resistant Prostate Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Actual Study Start Date : January 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood, serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981109


Locations
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Sponsors and Collaborators
Dendreon
Investigators
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Study Director: Bruce Brown, MD Dendreon Pharmaceuticals, LLC
  Study Documents (Full-Text)

Documents provided by Dendreon:
Study Protocol and Statistical Analysis Plan  [PDF] August 1, 2014

More Information
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Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01981109    
Other Study ID Numbers: P12-1
First Posted: November 11, 2013    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases