UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018964 |
|---|---|
| Receipt number | R000021928 |
| Scientific Title | Japanese research for patients with non-metastatic castration resistant prostate cancer - enzalutamide |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2019/03/14 09:47:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
micsugi@med.kagawa-u.ac.jp
Public contact
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
micsugi@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021928
