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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004072
Receipt No. R000004646
Scientific Title Early induction of docetaxel for castration resistance prostate cancer
Date of disclosure of the study information 2010/08/19
Last modified on 2014/03/19

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Basic information
Public title Early induction of docetaxel for castration resistance prostate cancer
Acronym PC-DOC
Scientific Title Early induction of docetaxel for castration resistance prostate cancer
Scientific Title:Acronym PC-DOC
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of the early induction of docetaxel for castration resistance prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response of PSA level
Key secondary outcomes 1)safeness
2)progression free survival
3) overall survival

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 early induction with docetaxel in the stage of the PSA biochemical failure with combined androgen blockade
Interventions/Control_2 the cases who reject to receive the early induction of docetaxel who entry in the control group with standard second hormonal therapy
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)Diagnosed prostate cancer under pathological examination
2)high risk (PSA over 20 or over Gleason score 8 or over T3staged), not permitted local radiotherapy or operation
3)initial hormonal therapy with combined androgen blockage adapted and PSA biochemical failure is decided without the PSA nadir lower than 0.2ng/dl , serum testosterone lower than 50 ng/ml)
4)age under 80
5)performance status 0 or 1
6)normal range of labo data
7)consensus for informed consent
8)the cases who reject to receive docetaxel will entry in the control group

Key exclusion criteria 1)active infection
2)fever over 38 cent degree
3)allergy with docetaxel or steroid
4)physician deny the entry
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouhei Nishikawa
Organization Department of Reparative and Regenerative Medicine, Institute of Medical Life Science, Mie University Graduate School of Medicine,
Division name Nephro-Urologic Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email kouheini@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouhei Nishikawa
Organization Mie University Graduate School of Medicine,
Division name Nephro-Urologic Surgery
Zip code
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Homepage URL
Email n-soga@clin.medic.mie-u.ac.jp

Sponsor
Institute M-CURE
Institute
Department

Funding Source
Organization Mie university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor M-CURE
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 三重大学(三重県),山田赤十字病院(三重県),三重県立総合医療センター(三重県),三重中央医療センター(三重県),済生会松阪総合病院(三重県),愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 19 Day
Last modified on
2014 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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