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

Terminated

• Conditions: Castration-Resistant Prostate Cancer

• Registration Number: NCT01981109
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-11
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2018-08-23
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Results First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 225

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration	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.

Trial Locations

Locations (57)

Alaska Clinical Research Center, LLC; 🇺🇸 Anchorage, Alaska, United States

Urological Associate of Southern Arizona; 🇺🇸 Tucson, Arizona, United States

Sequoia Urology Center; 🇺🇸 Atherton, California, United States

Prostate Oncology Specialist, Inc.; 🇺🇸 Marina Del Rey, California, United States

Sutter Medical Group; 🇺🇸 Sacramento, California, United States

Genesis Research; 🇺🇸 San Diego, California, United States

Urology Associates of San Luis Obispo; 🇺🇸 Templeton, California, United States

The Urology Center of Colorado; 🇺🇸 Denver, Colorado, United States

Advanced Urology, P.C; 🇺🇸 Parker, Colorado, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States

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