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

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

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

Study Overview

• Status: Unknown
• Conditions: Benign Prostatic Hyperplasia

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 855

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Medical University - WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Benign Prostatic Hyperplasia male paitents

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Liang-Ming Lee, Taipei Medical University WanFang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): May 11, 2011
• Last Update Submitted That Met QC Criteria: May 10, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 100006