Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer (PREDICT)
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|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
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|Condition or disease|
|Castration-Resistant Prostate Cancer|
|Study Type :||Observational|
|Actual Enrollment :||225 participants|
|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|
- 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
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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|
- 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.
- 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).
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
|Study Director:||Bruce Brown, MD||Dendreon Pharmaceuticals, LLC|
Documents provided by Dendreon:
|Other Study ID Numbers:||
|First Posted:||November 11, 2013 Key Record Dates|
|Results First Posted:||August 28, 2019|
|Last Update Posted:||August 28, 2019|
|Last Verified:||July 2019|
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases