prostate cancer
Conditions
Interventions
study group:Darolutamide (Nubeqa), 600mg bid + Goserellin Acetate (Zoladex), 10.8mg q12w
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male 2. Age =18y 3. Eastern Cooperative Oncology Group (ECOG) performance status =2 4. Documented histologically confirmed adenocarcinoma of the prostate 5. Clinical T3-T4(N0 or N1) 6. No previous local therapy for primary prostate disease and no contraindications for radical prostatectomy 7. Previous vasectomy or use acceptable birth control (indicating Barrier contraception containing spermicides) while on study drug and for 3 months following the last dose of study drug 8. Must agree not to donate blood while on study drug and for 3 months following the last dose of study drug 9. Willing and able to comply with study protocol and follow up schedule
Exclusion criteria
Exclusion criteria: 1. Previous orchiectomy or chemo therapy 2. Previous PARP inhibitor use 3. Known allergic reaction to study drug 4. Any psychological or physical condition that could potentially interfere with compliance with the study protocol and follow-up schedule by investigator consideration 5. Any abnormal laboratory tests that could put the subject at risk by investigator consideration 6. Known active hepatitis (type B or C), for the risk of transmission via blood or other body fluids 7. Any immune deficiency including human immunodeficiency virus [HIV] positive 8. Unwilling or not able to comply with study protocol or follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate specific antigen (PSA);tumore pathological features; | — |
Countries
China
Contacts
Public ContactLei Li
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed