Clinical trial NCT04869488: A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer
Official title: An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Castration Resistant Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fluzopali in combination with apatinib mesylate or fluzopali monotherapy with or without homologous recombinant repair-related gene mutations in metastatic castration-resistant prostate in subjects
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Comprehensive response rate
timeFrame: up to 2 years
Secondary outcomes:
measure: Radiological progression-free survival (rPFS)
timeFrame: up to 2 years
measure: Objective response rate (ORR)
timeFrame: At the time point of every 8 weeks，up to 2 years
measure: PSA response rate
timeFrame: At the time point of every 4 weeks，up to 2 years
measure: Time to PSA progression (PSA-TTP)
timeFrame: At the time point of every 4 weeks，up to 2 years
measure: Overall Survival (OS)
timeFrame: At the time point of every 2 months，up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: