UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028874 |
|---|---|
| Receipt number | R000033045 |
| Scientific Title | efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer |
| Date of disclosure of the study information | 2017/09/10 |
| Last modified on | 2022/09/05 10:03:14 |
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Basic information
Public title
efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Acronym
efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Scientific Title
efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Scientific Title:Acronym
efficacy of neoadjuvant androgen deprivation therapy fof high risk prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate whether neoadjuvant deprivation therapy used by degarelix and estramustine for high risk prostate cancer would be effective for the suppression of PSA recurrence after radical prostatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical recurrence after radical prostatectomy
Key secondary outcomes
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
Degarelix and estramustine would be preoperatively administrated for 3 months.
Interventions/Control_2
LH-RH agonist and estramustine would be preoperatively administrated for 3 months.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
Localized prostate cancer evaluated as a high risk,PS; 0-1
Bone marrow suppression was not observed. Liver and renal function was within normal range.
Key exclusion criteria
The patients for whom Dutasteride or another androgen deprivation therapy was administrated.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kojima |
Organization
Fukushima Medical University School of Medicine
Division name
the department of urology
Zip code
960-195
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
TEL
024-547-1316
pessoco@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Kataoka |
Organization
Fukushima Medical University School of Medicine,
Division name
Dept..of urology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
TEL
0245471316
Homepage URL
masaoka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
We have no conflict of Interest.
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
Fukushima Medical University
Address
1-Hikarigaoka
Tel
024-547-1316
masaoka@fmu.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 | 09 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033045
