prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years; 2. Histologically confirmed diagnosis of prostate cancer; 3. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) according to the EAU guideline 2020 version; 4. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC; 5. Radiographic or PSA progression at study entry; 6. Qualifying germline HRR mutation, HRR genes include BRCA1/2.
Exclusion criteria
Exclusion criteria: 1. Any previous treatment with PARP inhibitor, including olaparib; 2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy; 3. Other malignancy; 4. Subjects with known brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| radiographic progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;PSA progression free survival;overall survival; | — |
Contacts
Fudan university Shanghai Cancer Center