UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Title of the study (Brief title)	Switch from dutasteride to tadalafil in patent with benign prostatic hyperplasia
Region	Japan

Condition
Condition	benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is a randomized, open-label, multinational, 12-week study to evaluating switching effect from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change from Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS)
Key secondary outcomes	Change from Baseline to 12 Week Endpoint in IPSS Irritative Subscore, IPSS Voiding (Obstructive) Subscore, IPSS Quality of Life (QoL) Index, Uroflowmetry Parameter: Peak Flow Rate (Qmax), Number of Participants With Adverse Events International Index of Erectile Function (IIEF), Blood Pressure,ostvoid Residual Volume (PVR), Prostate Specific Antigen (PSA),testosterone, oxygen stress

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tadalafil 5mg one a day, for 12 weeks
Interventions/Control_2	No treatment, observation for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male
Key inclusion criteria	Males, 20 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms who were taking dutasteride Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1. Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Key exclusion criteria	Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1. History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1. Clinical evidence of prostate cancer at Visit 1. Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1. History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
Target sample size	200

Research contact person
Name of lead principal investigator	Chikara Ohyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Address	5 Zaifu-chou, Hirosaki, Japan
TEL	+81172395091
Email	shingorilla2@gmail.com

Public contact
Name of contact person	Shingo Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Address	5 Zaifu-chou, Hirosaki, Japan
TEL	+81172395091
Homepage URL
Email	shingorilla2@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
Anticipated trial start date	2016 Year 01 Month 20 Day
Last follow-up date	2018 Year 12 Month 29 Day
Date of closure to data entry	2018 Year 12 Month 29 Day
Date trial data considered complete	2018 Year 12 Month 29 Day
Date analysis concluded	2018 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 27 Day
Last modified on	2018 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023411