Prostate cancer
Conditions
Interventions
Hormone sensitive metastatic prostate cancer:None
Sponsors
Second Hospital of the Air Force Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male, 18 years old and above; 2. Histologically confirmed as prostate adenocarcinoma; 3.CT, MRI and/or bone scans confirm distal lymph node metastasis of prostate cancer (above the bifurcation of the abdominal aorta), bone metastasis, or soft tissue or visceral metastasis as evaluated according to RECIST 1.1; 4. The patient signs the informed consent form; 5. Life expectancy >=12 months; 6.ECOG PS 0-1 7. If the patient has received treatment with other androgen receptor inhibitors within one year, all adverse events need to completely disappear before the first use of darotamide.
Exclusion criteria
Exclusion criteria: 1. Previously received treatment with other novel androgen receptor inhibitors (enzalutamide, apatalutamide, rivelutamide) for metastatic prostate cancer for more than 3 months; 2. Patients diagnosed with castration-resistant prostate cancer (CRPC); 3. Have received external radiotherapy, particle implantation or radionuclide therapy within 2 weeks before enrollment; 4. Known allergy to any test drug or drug type; 5. Organ dysfunction or comorbidities that the researchers judged as unsuitable for darotamide treatment; 6. Have participated in or are currently participating in other clinical research projects; 7. According to the contraindications of the local marketing authorization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prostate-specific antigen;Prostatic magnetic resonance; | — |
Secondary
| Measure | Time frame |
|---|---|
| testosterone;Whole body bone nuclide scan;life quality; | — |
Countries
China
Contacts
Public ContactZhang Geng
Second Hospital of the Air Force Medical University
Outcome results
None listed