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Trial registered on ANZCTR


Registration number
ACTRN12612000853842
Ethics application status
Approved
Date submitted
11/08/2012
Date registered
14/08/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Randomized Controlled Trial Assessing the Efficacy of Withdrawing Alpha-blocker Following Initial Combination Therapy with 5-Alpha Reductase Inhibitor for Benign Prostatic Hyperplasia
Scientific title
A Prospective Randomized Controlled Trial Assessing the Efficacy of Withdrawing Alpha-blocker Following Initial Combination Therapy with 5-Alpha Reductase Inhibitor for Benign Prostatic Hyperplasia
Secondary ID [1] 281010 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostate Hyperplasia 287144 0
Condition category
Condition code
Renal and Urogenital 287465 287465 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tablet dutasteride 0.5mg daily, oral, 3 months
Intervention code [1] 285467 0
Treatment: Drugs
Comparator / control treatment
Tablet Dutasteride 0.5mg daily Orally and Alpha blocker tablet alfuzosin 10mg daily taken orally simultaneously for 3 months
Control group
Active

Outcomes
Primary outcome [1] 287732 0
International Prostate Symptoms Score
Timepoint [1] 287732 0
Basline and 3 months
Secondary outcome [1] 298729 0
Maximal urinary Flow Rate via uroflowmeter equipment
Timepoint [1] 298729 0
baseline and 3 months

Eligibility
Key inclusion criteria
patients with moderate or severe BPH based on IPSS score who were newly diagnosed and started on combination therapy or who were previously diagnosed and were already on combination therapy for a duration of not more than one year. All patients on combination therapy had a prostate size of more than 40g as assessed by digital rectal examination
Minimum age
40 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
All patients had a baseline PSA taken routinely and patients with a value higher than 4ng/ml underwent biopsy to screen for possible malignancy. Patients with PSA value less than 1.5ng/ml, prostate cancer and patients with recurrent urinary tract infections were excluded from our study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients recruited had undergone combination therapy with alpha-blocker and 5ARI (dutasteride) for a total period of one year. At the end of the combination therapy, all patient’s IPSS score and uroflowmetry (Qmax) were measured and taken as baseline values. Patients were then randomly assigned to continue combination therapy for a further 12 weeks (DT64) or discontinue alpha-blocker (DT52+/-12) using closed envelope method. There was no placebo involved in this study. Therefore, both investigator and subjects were not blinded in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization via computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 4482 0
Malaysia
State/province [1] 4482 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 285795 0
University
Name [1] 285795 0
Universiti Kebangsaan Malaysia Medical Centre
Country [1] 285795 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia Medical Centre
Address
Universiti Kebangsaan Malaysia Medical Centre,
Bandar Tun Razak,
56000 Cheras
Kuala Lumpur
Malaysia
Country
Malaysia
Secondary sponsor category [1] 284619 0
None
Name [1] 284619 0
Address [1] 284619 0
Country [1] 284619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287808 0
Universiti Kebangsaan Malaysia Research and Ethics Committee
Ethics committee address [1] 287808 0
Jalan Yaacob Latif, Bandar Tun Razak,
56000 Cheras,
Kuala Lumpur,
Malaysia
Ethics committee country [1] 287808 0
Malaysia
Date submitted for ethics approval [1] 287808 0
Approval date [1] 287808 0
15/06/2010
Ethics approval number [1] 287808 0
FF-197-2010

Summary
Brief summary
Combination therapy of alpha-blocker and 5-alpha-reductase inhibitor (5ARI) is effective for the treatment of benign prostate hyperplasia (BPH) but it is costly. This study aimed to assess the efficacy of withdrawing alpha-blocker following initial combination therapy with 5ARI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34564 0
Address 34564 0
Country 34564 0
Phone 34564 0
Fax 34564 0
Email 34564 0
Contact person for public queries
Name 17811 0
Christopher C.K. Ho
Address 17811 0
Department of Surgery,
Universiti Kebangsaan Malaysia Medical Centre,
Bandar Tun Razak,
56000 Cheras,
Kuala Lumpur,
Malaysia
Country 17811 0
Malaysia
Phone 17811 0
+60126826599
Fax 17811 0
+60391456684
Email 17811 0
[email protected]
Contact person for scientific queries
Name 8739 0
Christopher C.K. Ho
Address 8739 0
Department of Surgery,
Universiti Kebangsaan Malaysia Medical Centre,
Bandar Tun Razak,
56000 Cheras,
Kuala Lumpur,
Malaysia
Country 8739 0
Malaysia
Phone 8739 0
+60126826599
Fax 8739 0
+60391456684
Email 8739 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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