An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

Benign Prostatic Hyperplasia Clinical Trial

Official title:

An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01351987
• Other study ID #: 100006
• Status: Active, not recruiting
• Phase: N/A
• First received: May 10, 2011
• Last updated: May 10, 2011
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.

Description:

This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 855
• Est. completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Males, age ? 50 years

• Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)

• IPSS score ? 8 points and prostate volume ? 30 mL

• Total serum PSA ? 4.0 ng/mL and ? 20 ng/mL at screening

• Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.

• Dutasteride combination therapy will be allowed by investigator's prescription

• Ability to understand and willingly provide written informed consent

Exclusion Criteria:

• History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)

• With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study

• Use of finasteride within 6 months of screening visit

• Use of dutasteride within 12 months of screening visit

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan,