An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
1 other identifier
observational
855
1 country
1
Brief Summary
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 11, 2011
May 1, 2011
May 10, 2011
May 10, 2011
Conditions
Keywords
Eligibility Criteria
Benign Prostatic Hyperplasia male paitents
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liang-Ming Lee
Taipei Medical University WanFang Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
December 1, 2010
Study Completion
December 1, 2013
Last Updated
May 11, 2011
Record last verified: 2011-05