NCT01136226

Evaluate Recovery of Testosterone for Patients Using Eligard

A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Chesapeake Urology Research Associates · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Detailed description

This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Eligard (TM)	Eligard (TM) 22.5 mg administered at baseline and Month 3

Timeline

• Start date: 2003-10-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2010-06-03
• Last updated: 2018-10-24
• Results posted: 2013-07-16