UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of PSA decreasing of a pollen extract(Cernilton) for patients with prostate biopsy: multicenter study
Title of the study (Brief title)	Effect of PSA decreasing of a pollen extract(Cernilton)
Region	Japan

Condition
Condition	suspected prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effect of PSA decreasing of a pollen extract(Cernilton)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA decreasing rate cancer detection rate
Key secondary outcomes

Base
Study type	Interventional

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	Maneuver
Interventions/Control_1	prostate biopsy
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	patients with first episode for prostate biopsy patients who PSA lebel is from 4 to 20 ng/ml patients who have no induration on digital rectal examination
Key exclusion criteria	patients who using antimicrobial agent with in 3 months patients who using a pollen extract(Cernilton) within 1 year patients who decide not to join this study
Target sample size	120

Research contact person
Name of lead principal investigator	Shingo Yamamoto
Organization	Hyogo College of Medicine
Division name	Department of Urology
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
TEL	0798-45-6366
Email	shingoy@hyo-med.ac.jp

Public contact
Name of contact person	Yoshikazu Togo
Organization	Hyogo College of Medicine
Division name	Department of Urology
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
TEL	0798-45-6366
Homepage URL
Email	ytogo@hyo-med.ac.jp

Sponsor
Institute	Department of Urology,Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Department of Urology,Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2015 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 01 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	2015 Year 05 Month 15 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020391