UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Title of the study (Brief title)	Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Region	Japan

Condition
Condition	Benign hyperplasia, prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prostate cancer detection under PSA monitoring of dutasteride in patients with once negative biopsy and benign hyperplasia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of prostate cancer
Key secondary outcomes	Flucturation of PSA Change of prostate volume QOL Adverse event

Base
Study type

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Maneuver
Interventions/Control_1	Oral administration of dutasteride for once negative biopsy patients and re-biopsy after begining of dutasteride for a year
Interventions/Control_2
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	PSA level of over than 4ng/ml Men had one negative prostate biopsy Men had a benign prostate hyperplasia including criteria of PV>30ml and IPSS> 8-points.
Key exclusion criteria	Men had a prostatis before a half of year Men had surgery of prostate before enrollment Men took dutasteride, finasteride, prostal which were reduced prostate volume. Men had high grade intraepithelial neoplasia, atypical small acinar proliferation on one prostate biopsy Men are inappropriately decided by a doctor
Target sample size	300

Research contact person
Name of lead principal investigator	Tadashi Matsuda
Organization	Kansai Medical University
Division name	The department of urology and andrology
Address	2-3-1 Shin-machi Hirakata-shi Osaka city in Japan
TEL	072-804-0101
Email

Public contact
Name of contact person	Takaaki Inoue
Organization	Kansai Medical University
Division name	The department of urology and andrology
Address	10-15 Moriguchi-shi Fumizono-tyou Osaka in Japan
TEL	06-6992-1001
Homepage URL
Email	inouetak@hirakata.kmu.ac.jp

Sponsor
Institute	The department of urology and andrology in Kansai Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	The department of urology, Miyazaki University The department of urology, Kyoto University
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	2013 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 23 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 24 Day
Last modified on	2018 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012368