UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030346 |
|---|---|
| Receipt number | R000034649 |
| Scientific Title | Study of the usefulness of neoadjuvant chemo-hormone therapy for high-risk prostate cancer |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2022/01/27 13:51:43 |
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Basic information
Public title
Study of the usefulness of neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Acronym
Neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Scientific Title
Study of the usefulness of neoadjuvant chemo-hormone therapy for high-risk prostate cancer
Scientific Title:Acronym
Neoadjuvant chemo-hormone 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
Study of the usefulness of neoadjuvant hormone chemotherapy for high-risk prostate cance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2Y Desease-Free Survival (PSA =>0.2ng/ml)
Key secondary outcomes
Perioperative complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Degaarelix and estramustine would be preoperatively administared for 3 months.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. After receiving sufficient explanation for the participation of this study, those who gained written consent by the with sufficient understanding
2. Men aged 20 or over,and under 80.
3. Patients diagnosed with high risk based on the D'Amico risk group classification.
Key exclusion criteria
1. Patients who receiving hormonal therapy.
2. AST/ALT more than 100 IU/L by screening.
3. Patients who are judged inteligible for entry to this study principal investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Shiroki |
Organization
Fujita Health University Hospital
Division name
urology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9257
rshiroki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Fukaya |
Organization
Fujita Health University Hospital
Division name
urology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9257
Homepage URL
kofukaya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
NONE
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
Fujita Health University Hospital
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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 | 12 | Month | 11 | 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
20
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 11 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034649
