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.
Brief Title
Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Completion Date
Completion Date Type
Actual
Conditions
Castration-Resistant Prostate Cancer
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 ≥ 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).
* 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).
Inclusion 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.
* 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.
Gender
Male
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01981109
Org Class
Industry
Org Full Name
Dendreon
Org Study Id
P12-1
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients With Castration-Resistant Prostate Cancer
Primary Outcomes
Outcome Description
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.
Outcome Measure
Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration
Outcome Time Frame
Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404