UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study of selective estrogen modulators (SERMs) combined with maximum androgen blockade for metastatic prostate cancer
Title of the study (Brief title)	SERMs for metastatic PCA
Region	Japan

Condition
Condition	Bone metastatic prostate cancer
Classification by specialty	Urology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to evaluate the efficacy of selective estrogen modulators (SERMs) combined with maximum androgen blockade for the treatment with metastatic prostate cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA-relapse-free survival
Key secondary outcomes	VAS, and QOL

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	androgen deprivation therapy
Interventions/Control_2	raloxifene
Interventions/Control_3	toremifene
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	Not applicable
Gender	Male
Key inclusion criteria	prostate cancer diagnosed by prostate biopsy, Over 20 years old male with bone metastasis confirmed CT scan or bone scintigraphy, written informed consent
Key exclusion criteria	Liver dysfunction, thrombosis, using bisphosphonate, warfarin, phenobarbital, rifampicin, or ampicillin. Urinary tract infection, mental disease, the patients decided not applicable for this study by physician
Target sample size	15

Research contact person
Name of lead principal investigator	Tetsuya Fujimura
Organization	the University of Tokyo
Division name	Department of Urology
Address	7-3-1, Hongo, Bunkyo-ku
TEL	03-3815-5411
Email	fujimurat-uro@h.u-tokyo.ac.jp

Public contact
Name of contact person	Tetsuya Fujimura
Organization	the University of Tokyo
Division name	Department of Urology
Address	7-3-1, Hongo, Bunkyo-ku
TEL	0338155411
Homepage URL	http://www.h.u-tokyo.ac.jp/urology/
Email	fujimurat-uro@h.u-tokyo.ac.jp

Sponsor
Institute	the University of Tokyo
Institute
Department

Funding Source
Organization	the University of Tokyo
Organization
Division
Category of Funding Organization	Other
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	2011 Year 09 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 09 Month 14 Day
Anticipated trial start date	2010 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 09 Month 23 Day
Last modified on	2017 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007596