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

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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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021928


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name