Clinical Trials List
Protocol Number9785-CL-0232
NCT Number(ClinicalTrials.gov Identfier)NCT02294461
2014-01-01 - 2024-03-11
Phase III
Terminated9
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naive Subjects with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
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Trial Applicant
COVANCE TAIWAN SERVICES LIMITED
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Sponsor
Astellas Pharma Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Yen-Hwa Chang Division of Urology
- 沈書慧 Division of Urology
- Yi-Hsiu Huang Division of Urology
- 朱力行 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 林萬鈺 Division of Urology
- Shian-Shiang Wang Division of Urology
- Jian-Ri Li Division of Urology
- 熊小澐 Division of Urology
- Cheng-Kuang Yang Division of Urology
- 洪啟峰 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- CHUNG-HSIN CHEN Division of Urology
- YEN-HENG LIN Division of Urology
- - - Division of Urology
- Chia-Chi Lin Division of Urology
- - - Division of Urology
- 戴槐青 Division of Urology
- CHING-CHU LU Division of Urology
- SHUO-MENG WANG Division of Urology
- Yu-Chieh Tsai Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yung-Chang Lin Division of Urology
- PO-HUNG LIN Division of Urology
- Kai-Jie Yu Division of Urology
- 張英勛 Division of Urology
- Rita cheng Division of Urology
- 林柏宏 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 吳勝堂 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wen-Chi Chen Division of Urology
- Chi-Rei Yang Division of Urology
- Chi-Ping Huang Division of Urology
- Chin-Chung Yeh Division of Urology
- Chao-Hsiang Chang Division of Urology
- Kuo-Liang Chen Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wen-Horng Yang Division of Urology
- 蔡宗欣 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yung-Chin Lee Division of Urology
- 黃俊農 Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Prostate Cancer
Objectives
To assess the effect of enzalutamide on time to Prostate
Specific Antigen (PSA) progression as compared to placebo
in chemotherapy naive subjects with progressive metastatic
prostate cancer who have failed androgen deprivation therapy.
Test Drug
enzalutamide
Active Ingredient
enzalutamide
Dosage Form
capsule
Dosage
40
Endpoints
To assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naive subjects with progressive metastatic prostate cancer who have failed androgen deprivation therapy.
Inclution Criteria
Inclusion Criteria
Subject is eligible for the study if all of the following apply:
1. Age 18 or older and willing and able to provide written informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH analogue (agonist or antagonist) or
bilateral orchiectomy (i.e., surgical or medical castration);
4. Subjects who have not had a bilateral orchiectomy, must have a plan to maintain effective
GnRH-analogue therapy for the duration of the study;
5. Serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the Screening visit;
6. Subjects receiving bisphosphonate and other approved bone targeting agents must have
been on stable doses for at least 4 weeks before Day 1 visit;
7. Progressive disease at study entry defined as one or more of the following three criteria
that occurred while the subject was on androgen deprivation therapy as defined in
inclusion criterion #3:
PSA progression defined by a minimum of two rising PSA levels with an interval of
≥ 1 week between each determination. Subjects who received an anti-androgen must
have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since
last bicalutamide or nilutamide). The PSA value at the Screening visit should be
≥ 2 µg/L (2 ng/mL);
Soft tissue disease progression defined by the Response Evaluation Criteria in Solid
Tumors, version 1.1 (RECIST 1.1);
Bone disease progression defined by Prostate Cancer Clinical Trials Working Group
2 (PCWG2) with two or more new lesions on bone scan;
8. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue
disease by CT/MRI. Subjects whose disease spread is limited to regional pelvic lymph
nodes are not eligible;
9. No prior cytotoxic chemotherapy for prostate cancer;
10. Asymptomatic or mildly symptomatic from prostate cancer (i.e., the score on the Brief
Pain Inventory – Short Form (Appendix 3) Question #3 must be < 4) at the Screening
visit and Day 1 visit;
11. Eastern Cooperative Oncology Group (ECOG) performance status 0–1 at the Screening
visit and Day 1 visit;
12. Estimated life expectancy of ≥ 6 months;
13. Able to swallow the study drug and comply with study requirements.
Subject is eligible for the study if all of the following apply:
1. Age 18 or older and willing and able to provide written informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH analogue (agonist or antagonist) or
bilateral orchiectomy (i.e., surgical or medical castration);
4. Subjects who have not had a bilateral orchiectomy, must have a plan to maintain effective
GnRH-analogue therapy for the duration of the study;
5. Serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the Screening visit;
6. Subjects receiving bisphosphonate and other approved bone targeting agents must have
been on stable doses for at least 4 weeks before Day 1 visit;
7. Progressive disease at study entry defined as one or more of the following three criteria
that occurred while the subject was on androgen deprivation therapy as defined in
inclusion criterion #3:
PSA progression defined by a minimum of two rising PSA levels with an interval of
≥ 1 week between each determination. Subjects who received an anti-androgen must
have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since
last bicalutamide or nilutamide). The PSA value at the Screening visit should be
≥ 2 µg/L (2 ng/mL);
Soft tissue disease progression defined by the Response Evaluation Criteria in Solid
Tumors, version 1.1 (RECIST 1.1);
Bone disease progression defined by Prostate Cancer Clinical Trials Working Group
2 (PCWG2) with two or more new lesions on bone scan;
8. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue
disease by CT/MRI. Subjects whose disease spread is limited to regional pelvic lymph
nodes are not eligible;
9. No prior cytotoxic chemotherapy for prostate cancer;
10. Asymptomatic or mildly symptomatic from prostate cancer (i.e., the score on the Brief
Pain Inventory – Short Form (Appendix 3) Question #3 must be < 4) at the Screening
visit and Day 1 visit;
11. Eastern Cooperative Oncology Group (ECOG) performance status 0–1 at the Screening
visit and Day 1 visit;
12. Estimated life expectancy of ≥ 6 months;
13. Able to swallow the study drug and comply with study requirements.
Exclusion Criteria
Exclusion Criteria
Subject will be excluded from participation if any of the following apply:
1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
investigator or sub-investigator, would make the subject inappropriate for enrollment;
2. Known or suspected brain metastasis or leptomeningeal disease;
3. History of another malignancy within the previous 5 years other than curatively treated
non melanomatous skin cancer;
4. Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin <
5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: subjects may not have received any
growth factors within 7 days or blood transfusions within 28 days before Screening visit);
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the
upper limit of normal (ULN), or total bilirubin > 1.5 times the ULN at the Screening
visit;
6. Creatinine > 177 µmol/L (2 mg/dL) at the Screening visit;
7. Albumin < 30 g/L (3.0 g/dL) at the Screening visit;
8. History of seizure including febrile seizure or any condition that may predispose to
seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of
consciousness requiring hospitalization). Also, current or prior treatment with antiepileptic medications for the treatment of seizures or history of loss of consciousness or
transient ischemic attack within 12 months before Day 1 visit;
9. Clinically significant cardiovascular disease including:
Myocardial infarction within 6 months before the Screening visit;
Uncontrolled angina within 3 months before the Screening visit;
Congestive heart failure (New York Heart Association (NYHA) class 3 or 4), or
subjects with history of congestive heart failure (NYHA class 3 or 4) in the past,
unless a screening echocardiogram or multi-gated acquisition scan performed within
3 months before the Screening visit results in a left ventricular ejection fraction that is
≥ 45%;
History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia,
ventricular fibrillation, torsades de pointes);
History of Mobitz II second degree or third degree heart block without a permanent
pacemaker in place;
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury
(mmHg) at the Screening visit;
Bradycardia as indicated by a heart rate of < 50 beats per minute on ECG at the
Screening visit;
Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or
diastolic blood pressure > 105 mmHg at the Screening visit;
10. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer
disease within last 3 months before the Screening visit);
11. Major surgery within 4 weeks before Day 1 Visit;
12. Use of opiate analgesics for pain from prostate cancer within 4 weeks before Day 1 visit;
13. Radiation therapy for treatment of the primary tumor within 3 weeks before Day 1 visit;
14. History of radiation or radionuclide therapy for treatment of metastasis;
15. Treatment with flutamide within 4 weeks before Day 1 visit;
16. Treatment with bicalutamide or nilutamide within 6 weeks before Day 1 visit;
17. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogens, cyproterone
within 4 weeks before Day 1 visit;
18. Treatment with systemic biologic therapy for prostate cancer (other than approved bone
targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity
within 4 weeks before Day 1 visit;
19. History of prostate cancer progression on ketoconazole;
20. Prior use of an investigational agent that blocks androgen synthesis (e.g., abiraterone
acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS
641988), or prior use of marketed abiraterone acetate;
21. Prior use of enzalutamide;
22. Use of an investigational agent within 4 weeks before Day 1 visit;
23. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are
known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater
than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks before
Day 1 visit;
24. Subject who is not willing to use appropriate contraception;
25. Any condition or reason that, in the opinion of the Investigator or Sub-investigator,
interferes with the ability of the subject to participate in the trial, which places the subject
at undue risk, or complicates the interpretation of safety data.
Subject will be excluded from participation if any of the following apply:
1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
investigator or sub-investigator, would make the subject inappropriate for enrollment;
2. Known or suspected brain metastasis or leptomeningeal disease;
3. History of another malignancy within the previous 5 years other than curatively treated
non melanomatous skin cancer;
4. Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin <
5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: subjects may not have received any
growth factors within 7 days or blood transfusions within 28 days before Screening visit);
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the
upper limit of normal (ULN), or total bilirubin > 1.5 times the ULN at the Screening
visit;
6. Creatinine > 177 µmol/L (2 mg/dL) at the Screening visit;
7. Albumin < 30 g/L (3.0 g/dL) at the Screening visit;
8. History of seizure including febrile seizure or any condition that may predispose to
seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of
consciousness requiring hospitalization). Also, current or prior treatment with antiepileptic medications for the treatment of seizures or history of loss of consciousness or
transient ischemic attack within 12 months before Day 1 visit;
9. Clinically significant cardiovascular disease including:
Myocardial infarction within 6 months before the Screening visit;
Uncontrolled angina within 3 months before the Screening visit;
Congestive heart failure (New York Heart Association (NYHA) class 3 or 4), or
subjects with history of congestive heart failure (NYHA class 3 or 4) in the past,
unless a screening echocardiogram or multi-gated acquisition scan performed within
3 months before the Screening visit results in a left ventricular ejection fraction that is
≥ 45%;
History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia,
ventricular fibrillation, torsades de pointes);
History of Mobitz II second degree or third degree heart block without a permanent
pacemaker in place;
Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury
(mmHg) at the Screening visit;
Bradycardia as indicated by a heart rate of < 50 beats per minute on ECG at the
Screening visit;
Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or
diastolic blood pressure > 105 mmHg at the Screening visit;
10. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer
disease within last 3 months before the Screening visit);
11. Major surgery within 4 weeks before Day 1 Visit;
12. Use of opiate analgesics for pain from prostate cancer within 4 weeks before Day 1 visit;
13. Radiation therapy for treatment of the primary tumor within 3 weeks before Day 1 visit;
14. History of radiation or radionuclide therapy for treatment of metastasis;
15. Treatment with flutamide within 4 weeks before Day 1 visit;
16. Treatment with bicalutamide or nilutamide within 6 weeks before Day 1 visit;
17. Treatment with 5α-reductase inhibitors (finasteride, dutasteride), estrogens, cyproterone
within 4 weeks before Day 1 visit;
18. Treatment with systemic biologic therapy for prostate cancer (other than approved bone
targeted agents and GnRH-analogue therapy) or other agents with anti-tumor activity
within 4 weeks before Day 1 visit;
19. History of prostate cancer progression on ketoconazole;
20. Prior use of an investigational agent that blocks androgen synthesis (e.g., abiraterone
acetate, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS
641988), or prior use of marketed abiraterone acetate;
21. Prior use of enzalutamide;
22. Use of an investigational agent within 4 weeks before Day 1 visit;
23. Use of herbal products that may have hormonal anti-prostate cancer activity and/or are
known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater
than the equivalent of 10 mg of prednisone/prednisolone per day within 4 weeks before
Day 1 visit;
24. Subject who is not willing to use appropriate contraception;
25. Any condition or reason that, in the opinion of the Investigator or Sub-investigator,
interferes with the ability of the subject to participate in the trial, which places the subject
at undue risk, or complicates the interpretation of safety data.
The Estimated Number of Participants
-
Taiwan
110 participants
-
Global
400 participants
