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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01351987
First received: May 10, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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


Condition
Benign Prostatic Hyperplasia

Study Type: Observational
Study Design: Observational Model: Case-Only
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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 855
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Benign Prostatic Hyperplasia male paitents

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351987

Locations
Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Liang-Ming Lee Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Liang-Ming Lee, Superintendent Office, Wanfang Hospital
ClinicalTrials.gov Identifier: NCT01351987     History of Changes
Other Study ID Numbers: 100006
Study First Received: May 10, 2011
Last Updated: May 10, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Adrenergic alpha-Antagonists
Dutasteride
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014