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Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide (JCASTRE-Zero)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Enzalutamide
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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.

Sites / Locations

  • Kagawa University Faculty of Medicine
  • University of Miyazaki Faculty of Medicine
  • Tokyo Medical Center
  • The Jikei university school of medicin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzalutamide Group

Arm Description

Outcomes

Primary Outcome Measures

PSA-progression-free survival (PSA-PFS)
Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first.

Secondary Outcome Measures

Overall survival (OS)
OS is defined as time from date of initial dose until date of death from any cause.
Progression-free survival (PFS)
PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first.
Metastasis free survival (MFS)
MFS is defined as time from date of initial dose until the date of first metastasis which confirmed by computed tomography (CT) and bone scintigraphy.
Time-to-PSA-progression (TTPP)
TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose).
PSA response rate
PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline, compared to PSA levels at week 2, every 12 weeks for up to 5 years after initial dose.
Time to first use of chemotherapy (TFC)
TFC is defined as time from date of initial dose until the date of first additional chemotherapy started for prostate cancer.
QOL assessment using Japanese version of the FACT-P scales
Quality of life (QOL) is assessed on both total scores and each domain scores using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales at baseline, week 2, week 60, withdrawal of treatment and at the end of treatment for up to 5 years.
Medication adherence (dosage)
Medication adherence is assessed in dosage of enzalutamide.
Medication adherence (duration)
Medication adherence is assessed in duration of enzalutamide.
Medication adherence (ratio)
Medication adherence is assessed in dosage rate of enzalutamide which is classfied into 3 categories: 1) >=80%, 2) >= 50% to < 80%, and 3) < 50%.
Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Full Information

First Posted
October 23, 2015
Last Updated
May 24, 2022
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kagawa University
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1. Study Identification

Unique Protocol Identification Number
NCT02588001
Brief Title
Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide
Acronym
JCASTRE-Zero
Official Title
Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Kagawa University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one 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. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. The end of the study is defined as follow-up assessment date at 3 years after the last participant enrollment. Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free survival (PFS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Intervention Description
All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one 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. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment.
Primary Outcome Measure Information:
Title
PSA-progression-free survival (PSA-PFS)
Description
Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first.
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS is defined as time from date of initial dose until date of death from any cause.
Time Frame
6 years
Title
Progression-free survival (PFS)
Description
PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first.
Time Frame
6 years
Title
Metastasis free survival (MFS)
Description
MFS is defined as time from date of initial dose until the date of first metastasis which confirmed by computed tomography (CT) and bone scintigraphy.
Time Frame
6 years
Title
Time-to-PSA-progression (TTPP)
Description
TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of >= 25% and >= 2 ng/ml above the nadir after initial dose).
Time Frame
6 years
Title
PSA response rate
Description
PSA response rate is defined as ratio of patients who have an decrease in PSA of >= 50% above baseline, compared to PSA levels at week 2, every 12 weeks for up to 5 years after initial dose.
Time Frame
At week 2, and every 12 weeks for up to 6 years after initial dose
Title
Time to first use of chemotherapy (TFC)
Description
TFC is defined as time from date of initial dose until the date of first additional chemotherapy started for prostate cancer.
Time Frame
6 years
Title
QOL assessment using Japanese version of the FACT-P scales
Description
Quality of life (QOL) is assessed on both total scores and each domain scores using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales at baseline, week 2, week 60, withdrawal of treatment and at the end of treatment for up to 5 years.
Time Frame
Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years
Title
Medication adherence (dosage)
Description
Medication adherence is assessed in dosage of enzalutamide.
Time Frame
6 years
Title
Medication adherence (duration)
Description
Medication adherence is assessed in duration of enzalutamide.
Time Frame
6 years
Title
Medication adherence (ratio)
Description
Medication adherence is assessed in dosage rate of enzalutamide which is classfied into 3 categories: 1) >=80%, 2) >= 50% to < 80%, and 3) < 50%.
Time Frame
6 years
Title
Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
6 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically or cytologically confirmed prostate cancer Patients with history of radical prostatectomy or radiation therapy for radical treatment Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy Patients with serum PSA 1 micrograms/L (1 ng/mL) or more 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) Patients with asymptomatic prostate cancer Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients with life expectancy of at least 12 months Patients who have signed written informed consent to participate in this study Exclusion Criteria: Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate Patients with history of steroid usage as treatment for prostate cancer Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide Patients with history of malignant tumor other than prostate cancer within past 3 years Patients with history of seizure or predisposing disease of seizure Patients with severe liver dysfunction Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study Patients who considered to be inappropriate for the study participation by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikio Sugimoto, MD, Ph.D.
Organizational Affiliation
Kagawa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kagawa University Faculty of Medicine
City
Kita-gun
State/Province
Kagawa-prefecture
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
University of Miyazaki Faculty of Medicine
City
Miyazaki-city
State/Province
Miyazaki-prefecture
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
The Jikei university school of medicin
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8461
Country
Japan

12. IPD Sharing Statement

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Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide

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