Prostate cancer
Conditions
Interventions
Experimental group:Abiraterone combined with fluzoparib
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years; 2. Understand the research steps and content, and voluntarily sign a written informed consent; 3. Patients must have histologically or cytologically confirmed prostate cancer and have been clinically determined to have oligometastatic hormone-sensitive prostate cancer based on imaging evaluation. Among them, oligometastasis is defined as: bone metastasis or lymph node metastasis outside the pelvis <= 5 and no visceral metastasis, and the time from diagnosis to enrollment time <= 6 months; 4. Patients need to maintain effective continuous luteinizing hormone-releasing hormone analog (LHRHa) therapy throughout the study treatment period; 5. PS<2 points.
Exclusion criteria
Exclusion criteria: 1. There are other malignant tumors, a history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), or other malignant tumors within 5 years before the first dose of this study (Except carcinoma in situ that has been completely remission and malignant tumors with slow progression determined by the investigator); 2. Received local treatment for prostate cancer (such as radical prostatectomy, radiotherapy, and brachytherapy); 3. Previous treatment including PARP inhibitor therapy, chemotherapy and mitoxantrone, cyclophosphamide, hormone deprivation therapy, CPY17 inhibitor, anti-androgen, new endocrine therapy or immunotherapy; 4. Concomitant use of a known strong or moderate CYP3A inhibitor. A washout period of at least 2 weeks prior to initiation of fluzoparib treatment; 5. Concomitant use of a known strong or moderate CYP3A inducer. A washout period of at least 5 weeks for phenobarbital or enzalutamide before initiation of fluzoparib and 3 weeks for other drugs; 6. Habitual drinking of grapefruit juice or excessive tea, coffee and/or caffeinated beverages, which cannot be quit during the test period; 7. During the study period, the use of drugs that may have an effect on P-gp, including but not limited to amiodarone, carvedilol, clarithromycin, dronedarone, itraconazole, lapatinib, lopinavir, ritonavir, propafenone, quinidine, ranolazine, saquinavir, telapravir, tiprunavir, verapamil; 8. The investigator considers it unsuitable to participate in this clinical trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Pathologically significant response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average time from medication to operation;Mean operating time;Bleeding volume;Postoperative urinary continence time;Biochemical progression-free survival; | — |
Countries
China
Contacts
Public ContactZou Qing
Jiangsu Cancer Hospital
Outcome results
None listed