UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034906 |
|---|---|
| Receipt number | R000039646 |
| Scientific Title | Investigation of neoadjuvant chemohormonal therapy before robot-assisted radical prostatectomy for the patients with high-risk prostate cancer. |
| Date of disclosure of the study information | 2018/11/16 |
| Last modified on | 2019/06/06 16:16:59 |
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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
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
morizane@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039646
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