UMIN-CTR Clinical Trial

Basic information
Public title	Study of the usefulness of neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Acronym	Neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Scientific Title	Study of the usefulness of neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Scientific Title:Acronym	Neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Study of the usefulness of neoadjuvant hormone chemotherapy for high-risk prostate cance
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2Y Desease-Free Survival (PSA =>0.2ng/ml)
Key secondary outcomes	Perioperative complications

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Degaarelix and estramustine would be preoperatively administared for 3 months.
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	80 years-old >
Gender	Male
Key inclusion criteria	1. After receiving sufficient explanation for the participation of this study, those who gained written consent by the with sufficient understanding 2. Men aged 20 or over,and under 80. 3. Patients diagnosed with high risk based on the D'Amico risk group classification.
Key exclusion criteria	1. Patients who receiving hormonal therapy. 2. AST/ALT more than 100 IU/L by screening. 3. Patients who are judged inteligible for entry to this study principal investigator or sub-investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ryoichi Middle name Last name Shiroki
Organization	Fujita Health University Hospital
Division name	urology
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-9257
Email	rshiroki@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Kosuke Middle name Last name Fukaya
Organization	Fujita Health University Hospital
Division name	urology
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-9257
Homepage URL
Email	kofukaya@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University Hospital
Institute
Department

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

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

IRB Contact (For public release)
Organization	Fujita Health University Hospital
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel	0562-93-2865
Email	f-irb@fujita-hu.ac.jp

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	2017 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Date of IRB	2017 Year 09 Month 14 Day
Anticipated trial start date	2017 Year 12 Month 11 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 11 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034649