Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Florida/South Georgia Veterans Health System
• Treatments: Dutasteride; Finasteride

Criteria

Inclusion Criteria:

1. Male with history of treatment with Finasteride for more than six months, and who demonstrate clinical evidence of failure (subjective symptoms of bladder outlet obstruction secondary to BPH-related LUTS; objective evidence: AUASS> 10;Q-max > 5cc/sec and <10c/sec (total voided volume of at least 125cc); post void volumes > 200cc)

2. Prostate volume > 30cc and < 80cc by transrectal ultrasound measurement

3. Total Serum PSA of < 15 ng/ml (corrected for Finasteride therapy)

4. Willingness and ability to give written informed consent and comply with study instructions and procedures.

Exclusion Criteria:

1. Clinical evidence of non-response to therapy with Finasteride for symptomatic BPH.

2. Total serum corrected PSA of greater than 15 ng/ml

3. History or clinical evidence of prostate cancer

4. History of acute urinary retention in three months prior.