patients with prostate cancer (no treatment)
Conditions
Interventions
investigational material(s)
Generic name etc : TAP-144-SR(6M)
INN of investigational material : leuprolide acetate
Therapeutic category code : 249 Other hormone preparations (including antihormone pre
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese patient confirmed prostate cancer histopathologically. 2. Patient has prostate cancer in the clinical stages of T1b-T4, N-any and M-any by TNM classification. 3. Patient has been judged eligible to receive hormone therapy for prostate cancer. 4. Patient has ECOG performance status of grades 0, 1, or 2 at screening. 5. Patient has no treatment for prostate cancer. 6. Patient meets the criteria of renal, bone-marrow and hepatic functions on the laboratory test results at screening: 7. Patient exceeds lower limit of standard level for serum testosterone at screening. 8. Patient with a serum PSA level at screening >= 4.0ng/dL. 9. Patient has been judged not to have any clinical problem based on the findings on physical examination and ECG at screening. 10. Patient's life expectancy is at least 12 months. 11. Patient agrees to stay in hospital for 16 days from the day before the initial administration.
Exclusion criteria
Exclusion criteria: 1. Patient has active multiple primary cancers. 2. Patient has taken spironolactone and adrenal corticosteroid within 4 weeks prior to initiating study treatment. 3. Patient has central nervous system metastasis which requires treatment or which is symptomatic. 4. Patient already has or may have renal disorder caused by spinal cord compression or ureteric obstruction. 5. Patient has a history of serious drug allergic reaction/hypersensitivity. 6. Patient has a history of, or has been diagnosed with thromboembolism including myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism, or cardiac failure. 7. Patient has a serious disease that may affect the life expectancy, or has a history of, or has been diagnosed with disease that is considered difficult to be appropriately controlled and to be followed up according to the study protocol.
Outcome results
None listed