A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Castration-Resistant Prostate Cancer
- Sponsor
- Dendreon
- Enrollment
- 225
- Locations
- 57
- Primary Endpoint
- Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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 ≥
- •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).
Outcomes
Primary Outcomes
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.