None listed
Conditions
Interventions
Drug : - Adding-Docetaxel arm: Adding 6 cycles of Docetaxel 75 mg/m2 to ADT + ARTA.
- Non-Docetaxel arm: ADT + ARTA.
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) A person who voluntarily agrees to participate in this study in writing 2) 18 years of age or older 3) Histologically or cytologically diagnosed prostate cancer (excluding neuroendocrine differentiation or small-cell histological feature) 4) De novo patients identified as metastatic disease in CT, MR, or Bone scan at the time of prostate cancer diagnosis 5) Patients under administration of ADT (LHRHagonist/antagonist orchiectomy) and ARTA (Abiraterone, Apalutamide, or Enzalutamide) prior to registration; however, the administration period of ADT and ARTA prior to registration shall not exceed 12 weeks. 6) ECOG PS 0-2 7) Adequate bone marrow function (absolute neutrophil count =1500/mm3 (=1.5×103/µL), platelet =100,000/mm2 (=100x109/L), and hemoglobin =9.0 g/L), appropriate kidney function (hemolytic creatinine <1.5xnormal), appropriate hepatic function (Total xtransferase 3 upper limit), If there are no abnormalities in other liver function tests, including gamma glutamyl transfertase (GGT), and extensive bone metastasis is accompanied, it is judged to be an increase due to bone metastasis, and up to 6.0 x normal upper limit can be registered.) 8) Radiotherapy for symptom control purposes for bone metastatic lesions is acceptable 9) Subjects who agree to use contraception (maintain abstinence or use male condoms for sexual intercourse) during the treatment period and for 6 months after the last dose 10) A person who understands the contents of a clinical trial, is cooperative in conducting the test, and is deemed to be able to participate until the end of the study
Exclusion criteria
Exclusion criteria: 1) Subjects with only local lymph node metastasis (N1, lymph node metastasis below aortic junction) 2) Subjects who have had any of the following prior treatments - If you started ADT 12 weeks before registration - If ARTA (Abiraterone, Enzalutamide) is started 12 weeks before registration - Patients who received cytotoxic anticancer drugs or immunotherapy for other second generation ARTA (such as darolutamide) or prostate cancer prior to registration 3) In the case of receiving radiation therapy within two weeks of registration 4) If there is an hypersensitivity to the clinical trial drug (Docetaxel) 5) In the case of taking azole-based antifungal drugs (myconazole, ketoconazole, itraconalzole, etc.), cyclosporin, terpenadin, erythromycin, clarithromycin, indinavir, nephazodon, nelpinavir, lithonavir, and tetrachyne, boricholivirin, etc 6) A drug containing polysorbate 80 has a history of severe hypersensitivity (e.g., carbazetaxel, tosilizumab, etc.) 7) A subjects who have medical problem within 6 months before study registratio : stroke, MI, severe/unstable angina pectoris, CHF (NYHA class III or IV) 8) If you have been diagnosed with another malignant tumor in the past two years. However, properly treated skin basal cell cancer or squamous epithelial cell cancer, cervical intraepithelial cancer, and thyroid cancer except for stage 4 can participate in the study. 9) Unregulated hepatitis B (registered HBV DNA level < 2000 IU/mL for chronic hepatitis B or HBV carrier) or those who have suffered from or are currently infected with hepatitis C (registered if HCV-RNA is negative) 10) Human immunodeficiency virus (HIV) infection confirmed 11) Medical conditions that may hinder research participation, such as severe active or uncontrolled infections (bacteria, viruses, and fungal infections) 12) When a subject of a gynecological clinical trial who is sexually active refuses to use a medically appropriate contraceptive method 13) Other serious illnesses or medical conditions 14) A subjects who is deemed inappropriate by other researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical progression-free survival (cPFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Radiologic progression-free survival (rPFS);CRPC-free survival;Time to PSA progression;Time to initiation of subsequent systemic therapy;PSA response rate;Time to first symptomatic skeletal event;Time to initiation of chronic opioid use;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJiyoon Kim
Hanyang University Seoul Hospital
Outcome results
None listed