A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC

Stopped early · Phase 3

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

Key facts

Study ID

NCT02438007

Run by

LTN PHARMACEUTICALS, INC.

People needed

953

Starts

2015-06-01

Expected to finish

2016-11-01

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Progressive metastatic (M1) disease on androgen deprivation therapy
• Detectable AR-V7 from circulating tumors (CTCs)
• ECOG performance status 0 or 1

You may not qualify if…

• Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)
• Prior treatment with chemotherapy for CRPC

Where it is running

• University Of Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCLA Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Prostate Oncology Specialists, Inc. — Marina del Rey, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• Urology Speciality Group — Torrance, California, United States
• University of Colorado Cancer Center Anschultz Cancer Pavilion — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Boca Raton Community Hospital, Inc. — Boca Raton, Florida, United States
• University of Florida Health Cancer Center — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• First Urology — Jeffersonville, Indiana, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• University of Maryland Greenenbaum Cancer Center — Baltimore, Maryland, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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