- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02588001
Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide (JCASTRE-Zero)
May 24, 2022 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kagawa-prefecture
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Kita-gun, Kagawa-prefecture, Japan, 761-0793
- Kagawa University Faculty of Medicine
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Miyazaki-prefecture
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Miyazaki-city, Miyazaki-prefecture, Japan, 889-1692
- University of Miyazaki Faculty of Medicine
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Tokyo
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Meguro-ku, Tokyo, Japan, 152-8902
- Tokyo Medical Center
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Minato-ku, Tokyo, Japan, 105-8461
- The Jikei university school of medicin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enzalutamide Group
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA-progression-free survival (PSA-PFS)
Time Frame: 6 years
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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.
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6 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 6 years
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OS is defined as time from date of initial dose until date of death from any cause.
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6 years
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Progression-free survival (PFS)
Time Frame: 6 years
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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.
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6 years
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Metastasis free survival (MFS)
Time Frame: 6 years
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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.
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6 years
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Time-to-PSA-progression (TTPP)
Time Frame: 6 years
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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).
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6 years
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PSA response rate
Time Frame: At week 2, and every 12 weeks for up to 6 years after initial dose
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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.
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At week 2, and every 12 weeks for up to 6 years after initial dose
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Time to first use of chemotherapy (TFC)
Time Frame: 6 years
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TFC is defined as time from date of initial dose until the date of first additional chemotherapy started for prostate cancer.
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6 years
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QOL assessment using Japanese version of the FACT-P scales
Time Frame: Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years
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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.
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Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years
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Medication adherence (dosage)
Time Frame: 6 years
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Medication adherence is assessed in dosage of enzalutamide.
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6 years
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Medication adherence (duration)
Time Frame: 6 years
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Medication adherence is assessed in duration of enzalutamide.
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6 years
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Medication adherence (ratio)
Time Frame: 6 years
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Medication adherence is assessed in dosage rate of enzalutamide which is classfied into 3 categories: 1) >=80%, 2) >= 50% to < 80%, and 3) < 50%.
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6 years
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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
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6 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mikio Sugimoto, MD, Ph.D., Kagawa University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
October 23, 2015
First Submitted That Met QC Criteria
October 26, 2015
First Posted (Estimate)
October 27, 2015
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIGU1506
- UMIN000018964 (Registry Identifier: UMIN-CTR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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