NCT03236688

Detection of ARv7 in the Plasma of Men With Advanced Metastatic Castrate Resistant Prostate Cancer (MCRP)

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Exosome Diagnostics, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide)

Detailed description

Primary Objective -Demonstrate detection of ARv7 splice variant transcripts from exosomes in the circulation of MCRPC patients pre and post treatment with selective Androgen pathway inhibitors (i.e. abiraterone and enzalutamide) Secondary and Exploratory Objectives * Correlate ARv7 status with PSA response (\>/=50% decline in PSA level from baseline, maintained for \>/=4 weeks) at any time after the initiation of therapy. * Comparison of median progression free survival (PFS) and overall survival (OS). * Determine additional molecular lesions in exoRNA and cfDNA in MCRPC patients post-treatment with androgen pathway inhibitors. * Correlate other AR-variants (non ARv7) with clinical outcomes including PSA response.

Conditions

• Metastatic Castrate Resistant Prostate Cancer

Timeline

• Start date: 2016-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2017-08-02
• Last updated: 2022-10-06

Locations

1 site across 1 country: United States