Carboplatin in patients with metastatic castrate resistant prostate cancer harboring somatic or germline homologous recombination repair (HRR) gene mutations: A phase II single-arm trial - CiPHeR

ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•Histological diagnosis of prostate cancer
•Serum testosterone < 50 ng/dL within 28 days before screening
•Documented current evidence of metastatic castration-resistant prostate cancer
•Prior treatment with docetaxel and at least one of the novel anti-androgen agent (abiraterone and
•enzalutamide)
•Mutation (germline or somatic) in the HRR pathway in either blood or biopsy sample, respectively
•Written informed consent to participate
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
•Adequate organ functions

•Patients with symptomatic brain metastases. A scan to confirm the absence of brain metastases isnot required.
•Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
•Patients unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria:
•A bone scan referred to as a superscan showing an intense
•symmetric activity in the bones
•No soft tissue lesion (measurable or non-measurable) that can
•be assessed by RECIST
•Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
•Patients with a known hypersensitivity to carboplatin

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