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

Phase 3

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Enzalutamide; Drug: Galeterone

• Registration Number: NCT02438007
• Lead Sponsor: LTN PHARMACEUTICALS, INC.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Study Start: 2015-06
• Primary Completion: 2016-07
• Study Completion: 2016-11
• Status Verified: 2017-09
• Disposition First Submitted: 2017-09-21
• Disposition First Submitted QC: 2017-09-21
• Disposition First Posted: 2017-09-28
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 953

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enzalutamide	Enzalutamide	-
Galeterone	Galeterone	-

Primary Outcome Measures

Name	Time	Method
Radiographic Progression-free survival	≥ 8 months

Secondary Outcome Measures

Name	Time	Method
Time to Initiation of Cytotoxic Chemotherapy	≥ 8 months
Overall Survival	≥ 8 months

Trial Locations

Locations (115)

Pinnacle Oncology Hematology; 🇺🇸 Scottsdale, Arizona, United States

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

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