UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040914 |
|---|---|
| Receipt number | R000046714 |
| Scientific Title | Prospective study on the clinical efficacy of Darolutamide in non-metastatic castration-resistant prostate cancer |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2023/06/29 21:34:54 |
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Basic information
Public title
Prospective study on the clinical efficacy of Darolutamide in non-metastatic castration-resistant prostate cancer
Acronym
Prospective study on the clinical efficacy of Darolutamide in non-metastatic castration-resistant prostate cancer
Scientific Title
Prospective study on the clinical efficacy of Darolutamide in non-metastatic castration-resistant prostate cancer
Scientific Title:Acronym
Prospective study on the clinical efficacy of Darolutamide in non-metastatic castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
non-metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We performed prospective study to verify the therapeutic effects and adverse events of darolutamide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will verify the time to treatment failure from the starting of dalorutamide administration.
Key secondary outcomes
(1)Overall survival, (2)Usefulness of sex hormone level as prognostic and efficacy predictors, (3)Usefulness of novel PSA-related markers as prognostic and efficacy predictors, (4) Searching for prognostic and efficacy predictors from pre-treatment patient background, (5) Searching for prognostic factors and efficacy predictive factors from PSA dynamics after dalorutamide administration, (6) Investigation on adverse event occurrence after dalorutamide administration
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
Darolutamide
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
| Not applicable |
Gender
Male
Key inclusion criteria
1 male, age >= 20 years old
2 hitologically proven prostate cancer
3 castrated state
4 castration resistant prostate cancer
5 ECOG PS 0 -2
6 Patients with no distant metastases on imaging
7 obtain by written consent
8 No history of chemotherapy treatment
9 Patients who have written consent for participation in this study
Key exclusion criteria
1 Epileptic state patients
2 Brain damage, apoplexy, brain metastatis, active epidural metastatis of cranium
3 Hypersensitivity to darolutamide or its component
4 Severe liver dysfunction
5 Severe kidney function
6 Cases with distant metastases at the first visit
7 Impropriate state judged by charged doctor
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
CRPC-TRG: castration resistant prostate cancer treatment research group
Division name
Department of Urology, Gunma University Graduate School of Medicine
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8303
miya.yoshi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
CRPC-TRG: castration resistant prostate cancer treatment research group
Division name
Department of Urology, Gunma University Graduate School of Medicine
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8303
Homepage URL
miya.yoshi@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of gunma university hosipital
Address
3-39-22 showa-machi,maebashi, gunma
Tel
027-220-8740
gunmaciru-office@umin.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
| 2020 | Year | 07 | Month | 31 | 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
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is still enrolling cases (June 29, 2023).
Management information
Registered date
| 2020 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046714
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| Registered date | File name |
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