UMIN-CTR Clinical Trial

Basic information
Public title	Japanese research for patients with non-metastatic castration resistant prostate cancer - enzalutamide
Acronym	JCASTRE-Zero
Scientific Title	Japanese research for patients with non-metastatic castration resistant prostate cancer - enzalutamide
Scientific Title:Acronym	JCASTRE-Zero
Region	Japan

Condition
Condition	Non-metastatic castration resistant prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Prostate specific antigen-progression-free survival (PSA-PFS)
Key secondary outcomes	1) Overall survival (OS) 2) Progression-free survival (PFS) 3) Metastasis free survival (MFS) 4) Time to prostate-specific antigen (PSA) progression (TTPP) 5) PSA response rate 6) Time to first use of chemotherapy (TFC) 7) Quality of life assessment using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales 8) Medication adherence 9) Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

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	All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within 1 week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria.
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) Patients with histologically or cytologically confirmed prostate cancer 2) Patients with history of radical prostatectomy or radiation therapy for radical treatment 3) Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration 4) Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less 5) Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed 6) Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy 7) Patients with serum PSA 1 micrograms/L (1 ng/mL) or more 8) Patients with no confirmed remote metastasis after diagnosis of prostate cancer (excluding lymph nodes metastasis with a minor axis of less than 15 mm which considered to be nonmeasurable in the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1) 9) Patients with asymptomatic prostate cancer 10) Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1 11) Patients with life expectancy of at least 12 months 12) Patients who have signed written informed consent to participate in this study
Key exclusion criteria	1) Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)), or treatment with enzalutamide or abiraterone acetate 2) Patients with history of steroid usage as treatment for prostate cancer 3) Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide 4) Patients with history of malignant tumor other than prostate cancer within past 3 years 5) Patients with history of seizure or predisposing disease of seizure 6) Patients with severe liver dysfunction 7) Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study 8) Patients who considered to be inappropriate for the study participation by the investigator.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Mikio Middle name Last name Sugimoto
Organization	Kagawa University Faculty of Medicine
Division name	Department of Urology
Zip code	7610793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	087-898-5111
Email	micsugi@med.kagawa-u.ac.jp

Public contact
1st name of contact person	1st name Mikio Middle name Last name Sugimoto
Organization	Kagawa University
Division name	Department of Urology
Zip code	7610793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL	087-898-5111
Homepage URL
Email	micsugi@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University Faculty of Medicine
Institute
Department

Funding Source
Organization	Astellas Phrma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa University
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel	0878985111
Email	micsugi@med.kagawa-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	2015 Year 10 Month 01 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	No longer recruiting
Date of protocol fixation	2015 Year 08 Month 17 Day
Date of IRB	2015 Year 08 Month 17 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 10 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021928