JCASTRE-Zero: Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enzalutamide Group
|
Drug: Enzalutamide
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.
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Outcome Measures
Primary Outcome Measures
- PSA-progression-free survival (PSA-PFS) [6 years]
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) [6 years]
OS is defined as time from date of initial dose until date of death from any cause.
- Progression-free survival (PFS) [6 years]
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) [6 years]
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) [6 years]
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 [At week 2, and every 12 weeks for up to 6 years after initial dose]
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) [6 years]
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 [Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years]
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) [6 years]
Medication adherence is assessed in dosage of enzalutamide.
- Medication adherence (duration) [6 years]
Medication adherence is assessed in duration of enzalutamide.
- Medication adherence (ratio) [6 years]
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 [6 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with histologically or cytologically confirmed prostate cancer
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Patients with history of radical prostatectomy or radiation therapy for radical treatment
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Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration
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Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less
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Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed
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Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy
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Patients with serum PSA 1 micrograms/L (1 ng/mL) or more
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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)
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Patients with asymptomatic prostate cancer
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Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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Patients with life expectancy of at least 12 months
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Patients who have signed written informed consent to participate in this study
Exclusion Criteria:
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Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate
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Patients with history of steroid usage as treatment for prostate cancer
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Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide
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Patients with history of malignant tumor other than prostate cancer within past 3 years
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Patients with history of seizure or predisposing disease of seizure
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Patients with severe liver dysfunction
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Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
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Patients who considered to be inappropriate for the study participation by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kagawa University Faculty of Medicine | Kita-gun | Kagawa-prefecture | Japan | 761-0793 |
| 2 | University of Miyazaki Faculty of Medicine | Miyazaki-city | Miyazaki-prefecture | Japan | 889-1692 |
| 3 | Tokyo Medical Center | Meguro-ku | Tokyo | Japan | 152-8902 |
| 4 | The Jikei university school of medicin | Minato-ku | Tokyo | Japan | 105-8461 |
Sponsors and Collaborators
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Kagawa University
Investigators
- Principal Investigator: Mikio Sugimoto, MD, Ph.D., Kagawa University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TRIGU1506
- UMIN000018964