UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061776 |
|---|---|
| Receipt number | R000069089 |
| Scientific Title | Genomic Correlates of Clinical Outcome in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Enzalutamide |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/03 01:59:50 |
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Basic information
Public title
A Prospective Multicenter Study of Exploring Genomic Correlates of Clinical Outcome in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Enzalutamide
Acronym
Menz study
Scientific Title
Genomic Correlates of Clinical Outcome in Patients with Metastatic Castration-Sensitive Prostate Cancer Receiving Enzalutamide
Scientific Title:Acronym
Menz study
Region
| Japan |
Condition
Condition
Metastatic Castration-Sensitive Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aimed to characterize somatic mutation profiles and their association with clinical outcomes in patients with metastatic castration-sensitive prostate cancer treated with enzalutamide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the prevalence of somatic mutations in patients with metastatic castration-sensitive prostate cancer.
Key secondary outcomes
Key secondary endpoints included the identification of genomic alterations associated with castration-resistant progression.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Age 20 or older
Histologically confirmed prostate adenocarcinoma without neuroendocrine or small-cell differentiation
Patients with metastatic castration-sensitive prostate cancer who were treated with enzalutamide
Hormonal therapy (androgen deprivation therapy or combined androgen blockade) administered within 6 months before enrollment was permitted if the disease was clinically stable at the time of study entry
Patients who had received neoadjuvant or adjuvant hormonal therapy for less than 36 months were eligible provided that a longer than 12-month washout period had elapsed before enrollment
Key exclusion criteria
Prior treatment with abiraterone, apalutamide, darolutamide, or docetaxel in the metastatic castration-sensitive setting
Known allergy to enzalutamide
Contraindications to hormonal therapy
Absence of available formalin-fixed paraffin-embedded tumor specimens
Insufficient DNA quality for genomic analysis
Any condition deemed inappropriate for study participation by the treating physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hatano |
Organization
The University of Osaka Graduate School of Medicine
Division name
Urology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita, Osaka, Japan
TEL
0668793531
koj.hatan@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hatano |
Organization
The University of Osaka Graduate School of Medicine
Division name
Urology
Zip code
565-0871
Address
Yamadaoka 2-2, Suita, Osaka, Japan
TEL
0668793531
Homepage URL
koj.hatan@gmail.com
Sponsor or person
Institute
The University of Osaka Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital
Address
2-2 Yamadaoka, Suita, Japan
Tel
0662108289
mirai@hp-mctr.med.osaka-u.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
| 2026 | Year | 06 | Month | 03 | 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
76
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
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069089
