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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039155
Receipt No. R000044657
Scientific Title Fpllow-up study of multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide (OCUU-CRPC follow-up study).
Date of disclosure of the study information 2020/01/21
Last modified on 2021/10/07

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Basic information
Public title Fpllow-up study of multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide (OCUU-CRPC follow-up study).
Acronym Fpllow-up study of multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide (OCUU-CRPC follow-up study).
Scientific Title Fpllow-up study of multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide (OCUU-CRPC follow-up study).
Scientific Title:Acronym Fpllow-up study of multicenter, prospective, randomised and comparative study of alternative anti-androgen (AA) therapy and early initiating enzalutamide for castration-resistant prostate cancer (CRPC) after combined androgen blockade (CAB) therapy with bicalutamide (OCUU-CRPC follow-up study).
Region
Japan

Condition
Condition Castration-resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To observe the long-term outcomes of patients enrolled in the OCUU-CRPC study comparing first-line treatment for castration-resistant prostate cancer after bicalutamide-based CAB therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival (OS)
Key secondary outcomes time to treatment failure of ENZA therapy (TTF-ENZA)

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 Of the 103 patients who obtained consent in the OCUU-CRPC study and were assigned at each institution.
Key exclusion criteria None
Target sample size 103

Research contact person
Name of lead principal investigator
1st name Taro
Middle name
Last name Iguchi
Organization Osaka City University Graduate School of Medicine
Division name Department of Urology
Zip code 545-8585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
TEL 06-6645-3857
Email taro@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Taro
Middle name
Last name Iguchi
Organization Osaka City University Graduate School of Medicine
Division name Department of Urology
Zip code 545-8585
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, Japan
TEL 06-6645-3857
Homepage URL
Email taro@msic.med.osaka-cu.ac.jp

Sponsor
Institute Department of Urology, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Osaka City University Graduate School of Medicine
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 Ethical Committee of Osaka City University Graduate School of Medicine
Address Abeno Medics 6F, 1-2-7 Asahimachi, Abeno-ku, Osaka, Japan
Tel 06-6645-3456
Email ethics@med.osaka-cu.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 01 Month 21 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 103
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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
2019 Year 02 Month 21 Day
Anticipated trial start date
2019 Year 02 Month 21 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information Observation items, inspection items, methods, etc.
- Prostate cancer treatment drug name, drug use period
- Opioid use and duration
- Blood test data (PSA, ALP, LDH, other blood chemistry test data)
- Imaging results (CT, bone scintigraphy, MRI, PET)

Management information
Registered date
2020 Year 01 Month 14 Day
Last modified on
2021 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044657

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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