NCT02146937

A Phase 2 Study of Bicalutamide Plus Finasteride in Men With MRI Detectable Prostate Nodules Undergoing Active Surveillance

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single site, single arm Phase II study to evaluate the combination of bicalutamide plus finasteride in men with MRI detectable significant prostate nodules followed on active surveillance.

Detailed description

This research is being done to determine the negative re-biopsy rate as determined by MRI/TRUS fusion guided biopsy targeting the dominant nodule site defined by pre-treatment MRI following three months (90 days) of combination bicalutamide plus finasteride.

Conditions

• Detectable Prostate Nodules

Interventions

Type	Name	Description
DRUG	Bicalutamide plus Finasteride- Combination therapy	3-month (90-day) course of bicalutamide 50 mg by mouth daily and finasteride 5 mg by mouth daily

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-05-26
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States