Castration-resistant prostate cancer
Conditions
Interventions
Experimental group:Darolutamide
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male aged over 18 years; 2. Histologically or cytologically confirmed adenocarcinoma CRPC, defined as disease progression in spite of ADT, may be manifested by confirmed elevated serum PSA levels (As defined by PCWG3: consistently elevated PSA levels were observed with baseline PSA >=1.0 ng/mL at least once a week apart); 3. According to the imaging evaluation results obtained within 3 months prior to the initial administration of darotamine, there was no evidence of metastasis; 4. Prior to enrollment in this study, the investigator had decided to start darotamine therapy according to routine treatment practice; 5. Signed informed consent; 6. Life expectancy >=3 months.
Exclusion criteria
Exclusion criteria: 1. Participate in intervention trials using interventions other than routine clinical practice; 2. Contraindications specified in the local marketing authorization; 3. Previous treatment with darotamine (referring to those who started earlier than 3 days before enrollment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metastasis-Free Survival;Time to Symptomatic Skeletal Event;Time to Prostate-specific Antigen (PSA) Progression;Survival Rate;Duration of Darolutamide Therapy; | — |
Countries
China
Contacts
Public ContactHuang Jian
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed