UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of genetic polymorphisms for predicting response to treatment and progression of prostate tumor
Title of the study (Brief title)	Polymorphisms for Predicting Progression of Prostate tumor (PoPProP trial)
Region	Japan Asia(except Japan) North America Europe

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Exploratory study of single nucleotide polymorphisms (SNPs) associated with progression of metastatic prostate cancer.
Basic objectives2	Others
Basic objectives -Others	To identify single nucleotide polymorphisms which are associated with progression risk and response to drug therapies in advanced (metastatic) prostate cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Significant association between SNPs and cancer-specific survival
Key secondary outcomes	Significant association between SNPs and 1. Overall survival 2. Time to castration resistant prostate cancer (CRPC) 3. Time to any death from CRPC 4. Time to cancer death from CRPC

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1. Prostate cancer patients 20 years old or older 2. Pathologically diagnosed prostate cancer 3. Clinical stage: TanyNanyM1
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	Tomonori Habuchi
Organization	Akita University Graduate School of Medicine
Division name	Department of Urology
Address	1-1-1 Hondo, Akita
TEL	018-884-6156
Email	tsuchiya@med.akita-u.ac.jp

Public contact
Name of contact person	Norihiko Tsuchiya
Organization	Yamagata University Faculty of Medicine
Division name	Department of Urology
Address	2-2-2 Iida-nishi, Yamagata
TEL	023-628-5368
Homepage URL
Email	ntsuchiya@med.id.yamagata-u.ac.jp

Sponsor
Institute	Department of Urology, Akita University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Akita University Graduate School 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	秋田大学医学部附属病院（秋田県）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 02 Month 14 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 06 Month 01 Day
Date analysis concluded	2019 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective exploratory study

Management information
Registered date	2013 Year 01 Month 15 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007913