Prostate Caner
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged =18 years; 2.Histologically or cytologically confirmed prostate adenocarcinoma, clinically identified as local according to imaging evaluation, and classified as high-risk or above according to NCCN guidelines; 3.Effective and continuous luteinizing hormone releasing hormone analogue (LHRHa) treatment throughout the study; 4.Radical prostatectomy as the main treatment for prostate cancer; 5.Able to understand and willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Other malignancies, a history of myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML), or other malignancies within 5 years prior to the first administration of this study (except for cancer in situ with complete remission and malignancies with slow progression determined by the researchers); 2. Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy and brachytherapy); 3. Previous treated with PARP inhibitor therapy, chemotherapy, mitoxantrone, cyclophosphamide, hormone deprivation therapycpy17 inhibitors, antiandrogens, new endocrine therapy or immunotherapy (excluding previous antiandrogens or abiraterone treatment for no more than one month); 4. Previous treated with strong or moderate intensity CYP3A inhibitors. The washout period was at least 2 weeks before the treatment; 5. Previous treated with strong or moderate intensity CYP3A inducers. The washout period of phenobarbital or enzalutamide was at least 5 weeks, and 3 weeks for other drugs; 6. Habitual drinking grapefruit juice or excessive tea, coffee and/or caffeinated beverages, could not be given up during the trial period; 7. Drugs that may affect P-gp could not be discontinued during the study; 8. Not suitable to participate in this clinical trial judged by researcher for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical progression free survival;Metastasis free survival; | — |
Countries
China
Contacts
Fudan university Shanghai Cancer Cente