Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis

Outcome Time Frame:

Immediate - no longitudinal data collected

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

RA-2004-040

NCT ID:

NCT01310192

Start Date:

June 2004

Completion Date:

July 2008

Related Keywords:

• Prostate Cancer
• Prostatic Neoplasms