None listed
Conditions
Interventions
Drug : If apalutamide is used in metastatic hormone-sensitive prostate cancer and written consent is given to participate in this clinical trial, a screening test will be performed. If the screening t
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Prostate cancer confirmed by histological examination 2) Distant metastasis confirmed by CT, bone scan, or MR 3) Adequate blood function (absolute neutrophil count =2×109/L, platelet count =100×109/L, hemoglobin =8 g/dL) 4) Adequate renal function (serum creatinine =ULN or creatinine clearance =60 mL/min) 5) Adequate liver function (aspartate aminotransferase and alanine aminotransferase 2.5×ULN)
Exclusion criteria
Exclusion criteria: 1) Subjects under 19 years of age and 80 years of age or older 2) Prostate cancer other than adenocarcinoma (neuroendocrine carcinoma, prostate small cell carcinoma, or ductal carcinoma) 3) Hypersensitivity to drugs used in the study 4) Other uncontrolled systemic diseases including active infection, active autoimmune disease, and uncontrolled cardiovascular disease (hypertension, diabetes, myocardial infarction, cerebral infarction, etc.) 5) Difficulty cooperating with treatment and follow-up observation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| skin rash occurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade 3 or higher skin rash; time until skin rash occurs;PSA value change;rash duration;rash recurrence;dose interruption rate;dose reduction rate;discontinuation rate;skin rash occurrence | — |
Countries
Korea, Republic of
Contacts
Public ContactSe Young Choi
Chung-Ang University
Outcome results
None listed