UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004072 |
|---|---|
| Receipt number | 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 10:12:48 |
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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
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
n-soga@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
M-CURE
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004646
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