A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer

An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer

Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.

Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Age ≥18 years old;
3. Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
4. It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Has a life expectancy of ≥ 12 weeks.

Exclusion Criteria:

1. Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
2. Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
3. Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
4. The subject has cancerous meningitis, or untreated central nervous system metastasis;
5. Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
6. Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number> upper limit of normal );
7. According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.