UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer.
Acronym	Neoadjuvant chemohormonal therapy for high-risk prostate cancer.
Scientific Title	Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer.
Scientific Title:Acronym	Neoadjuvant chemohormonal 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	Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological outcome
Key secondary outcomes	PSA recurrence rate after prostatectomy

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Male
Key inclusion criteria	1) age <=75 years. 2) Prostate cancer patients who will be received RARP 3)Performance Status(PS:ECOG) 0-1. 4)Total bilirubin level less than 1.5 times the upper limit of normal. AST/ALT(GOT/GPT) level less than 2.5 times the upper limit of normal. Serum creatinine level less than 1.5 times the upper limit of normal. Hgb level more than 8.0g/dL, WBC level more than 3000/ul, Plt level more than 100,000/ul. 5)High risk patients with the total score more than 6 point according to our scoring system. In addition, also in the cases of less than six sum total score, we incorporate the following patients. The patients who have the lymph node metastasis up to three pieces in the regional lymphnode in a pelvis, or the patients who have bone metastasis up to three pieces.
Key exclusion criteria	1)Patient with the treatment history of docetaxel. 2)Patient with deep vein thrombosis. 3)Patient who has the past history of heart failure or myocardial infarction. 4)Patient with the past history of interstitial pneumonia. 5)An infectible patient. 6)Patient with diabetes with difficult control. 7)Patient who received medication of other investigational drugs within three months before the start of this study. 8)Patient who already received radiotherapy for prostate cancer. 9)Patient who is under treatment of other neoplasm except for the prostate cancer now. 10)Patient who is using the medicine with a possibility that blood concentration may rise by combined use. 11)Patient who wants to make a child in the future. 12)In addition, those whom the research responsibility doctor judged to be unsuitable as a research candidate. 13)Prostate cancer patient who is having hormone therapy already done for six months or more. 14)Patient who has four or more lymph node metastases in a pelvis. 15)Patient who has four or more distant metastases.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takenaka Atsushi
Organization	Tottori University Hospital
Division name	Urology
Zip code
Address	36-1,Nishi-cho,Yonago,Tottori
TEL	0859-38-6607
Email	atake@tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Morizane Shuichi
Organization	Tottori University Hospital
Division name	Urology
Zip code
Address	36-1,Nishi-cho,Yonago,Tottori
TEL	0859-38-6607
Homepage URL
Email	morizane@tottori-u.ac.jp

Sponsor
Institute	Tottori University Hospital
Institute
Department

Funding Source
Organization	Tottori University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 11 Month 16 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	Terminated
Date of protocol fixation	2018 Year 11 Month 15 Day
Date of IRB	2016 Year 08 Month 26 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 15 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039646