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

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ClinicalTrials.gov Identifier: NCT01981109
Recruitment Status : Recruiting
First Posted : November 11, 2013
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Dendreon

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 Type : Observational
Estimated Enrollment : 2000 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
Study Start Date : January 2012
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Characteristics in patients with Castration-Resistant Prostate Cancer and no known M1. [ Time Frame: Up until 5 years after the last patient is registered ]
    To evaluate characteristics predictive of a baseline imaging study positive for M1 in patients with Castration-Resistant Prostate Cancer and no known M1.


Secondary Outcome Measures :
  1. The sites of distant metastases [ Time Frame: Within the 2 year enrollment period ]
    To characterize the sites of distant metastases by determining the proportion of patients with Castration-Resistant Prostate Cancer and no known M1 who receive a diagnosis of soft tissue and/or bone metastases at the time of the baseline imaging study.

  2. Characteristics in patients with Castration-Resistant Prostate Cancer and no distant metastases at baseline. [ Time Frame: Up until 3 years after the last patient is registered ]
    To evaluate characteristics predictive of a future imaging study positive for M1 in patients with Castration-Resistant Prostate Cancer and no distant metastases at baseline.


Biospecimen Retention:   Samples With DNA
Whole blood, serum


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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).

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


Contacts
Contact: Sally Anne Jones Sallyanne.Jones@dendreon.com
Contact: Evett Oh 949-436-9104 eoh@dendreon.com

  Show 61 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01981109     History of Changes
Other Study ID Numbers: P12-1
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases