UMIN-CTR Clinical Trial

Basic information
Public title	efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Acronym	efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Scientific Title	efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Scientific Title:Acronym	efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of the present study is to evaluate whether neoadjuvant deprivation therapy used by degarelix and estramustine for high risk prostate cancer would be effective for the suppression of PSA recurrence after radical prostatectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Biochemical recurrence after radical prostatectomy
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Degarelix and estramustine would be preoperatively administrated for 3 months.
Interventions/Control_2	LH-RH agonist and estramustine would be preoperatively administrated for 3 months.
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	75 years-old >=
Gender	Male
Key inclusion criteria	Localized prostate cancer evaluated as a high risk,PS; 0-1 Bone marrow suppression was not observed. Liver and renal function was within normal range.
Key exclusion criteria	The patients for whom Dutasteride or another androgen deprivation therapy was administrated.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Kojima
Organization	Fukushima Medical University School of Medicine
Division name	the department of urology
Zip code	960-195
Address	1 Hikarigaoka, Fukushima 960-1295, Japan
TEL	024-547-1316
Email	pessoco@fmu.ac.jp

Public contact
Name of contact person	1st name Masao Middle name Last name Kataoka
Organization	Fukushima Medical University School of Medicine,
Division name	Dept..of urology
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima 960-1295, Japan
TEL	0245471316
Homepage URL
Email	masaoka@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization	We have no conflict of Interest.
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	Fukushima Medical University
Address	1-Hikarigaoka
Tel	024-547-1316
Email	masaoka@fmu.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 09 Month 10 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
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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 21 Day
Date of IRB	2017 Year 05 Month 30 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2023 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 29 Day
Last modified on	2022 Year 09 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033045