UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000044657