prostate cancer
Conditions
Interventions
Intervention:Darotamine (once daily, 160mg, oral) combined with active surveillance
Comparison:Only active surveillance
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age is over 18 years old; 2. Patients diagnosed with low-risk focal prostate cancer (Gleason score 10), and the proportion of cancer cells in a single needle 10 years; 5. ECOG score>=2; 6. Able to understand the content of the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously received any local or systemic treatment for the prostate, such as anti-androgen therapy or radiotherapy; 2.Patients who have used oral glucocorticoids within one month before screening; 3.Patients who have used 5-a -reductase inhibitors within one month before screening or have used them for more than three months in the past two years; 4.Patients with severe comorbidities, such as cardiovascular diseases, liver or kidney dysfunction, or those with other malignant tumors; 5.Patients allergic to darolutamide and other clinical conditions that are not suitable for drug treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The progression time of pathological or therapeutic prostate cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of negative biopsy results at 1 year;The change in the proportion of positive needle tumors;PSA progress time;The incidence of secondary elevation of serum PSA levels; | — |
Countries
China
Contacts
Public ContactYu Fan
Peking University First Hospital
Outcome results
None listed