Patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Conditions
Interventions
All patients will receive androgen deprivation therapy ( ADT ) plus enzalutamide.
Radiotherapy to the primary tumor will be administered to all patients.
Intervention based on PSA response at 12 weeks
Sponsors
Toshiki Kijima
Takao Kamai
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with hormone - naive prostate cancer with metastases at diagnosis, confirmed by imaging studies ( CT, MRI, or bone scintigraphy ). 2) Patients with hormone-naive prostate cancer. However, patients who have initiated androgen deprivation therapy ( ADT ) - such as leuprorelin acetate, goserelin, degarelix acetate, or orchiectomy - or first-generation antiandrogens ( e.g., bicalutamide, flutamide ) within 12 weeks prior to enrollment are eligible. 3) Patients with an Eastern Cooperative Oncology Group ( ECOG ) Performance Status of 0 or 1 at the time of consent. 4) Patients aged 18 years or older. 5) Patients who have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have previously received treatment with apalutamide, enzalutamide, darolutamide, or abiraterone. 2) Patients with other active malignancies. However, patients with a history of early-stage cancer that has been cured by definitive surgery and has not recurred for at least one year prior to enrollment are eligible. 3) Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving PSA <= 0.2 ng/mL within 2 years after initiation of enzalutamide | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients achieving PSA <= 0.2 ng / mL at 12 weeks after initiation of enzalutamide 2) PSA progression-free survival (PSA-PFS) 3) Radiographic progression-free survival (rPFS) 4) Objective response rate (ORR) based on imaging 5) Overall survival (OS) 6)Patient-reported outcomes (PROs),including quality of life and treatment-related adverse effects | — |
Contacts
Public ContactKijima Toshik
Dokkyo Medical University
Outcome results
None listed