Last updated on November 2019

A Safety and Efficacy Study of SHR3680 in Metastatic Castration-Resistant Prostate Cancer Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hormone Refractory Prostate Cancer | Metastatic Prostate Carcinoma
  • Age: Between 18 - 80 Years
  • Gender: Male

Inclusion Criteria:

  • ECOG performance scale 0 - 1.
  • Life expectancy of more than 6 months.
  • Histologically or cytologic confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy
  • Evidence of prostate cancer progression by radiographic or PSA criteria
  • Radiological evidence of distant metastatic lesions
  • Serum testosterone level < 1.7 nmol/L (50 ng/dL) at the screening visit
  • Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 10e9/L, neutrophil > 1.5 10e9/L, Hb >90 g/L,total bilirubin and creatinine within upper limit of normal(ULN), and serum transaminase1.5the ULN).
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

  • Treatment with androgen receptor antagonists, 5-alpha reductase inhibitors, estrogens, or chemotherapy within 4 weeks of enrollment or plans to initiate treatment with any of these drugs during the study
  • Prior treatment with enzalutamide, abiraterone, or ketoconazole for prostate cancer
  • History of seizure or any conditions that may predispose to seizure
  • Concurrent or planned treatment with corticosteroids, medications known to have seizure potential, or herbal products known to decrease PSA levels
  • Planned to initiate any other anti-tumor therapies during the study
  • Less than 4 weeks from the last clinical trial
  • Evidence of brain metastasis or primary tumors
  • Clinically significant cardiovascular diseases
  • Abuse of alcohol or drugs
  • Severe concurrent disease, infection, or bone metastasis that, in the judgment of the investigator, would make the patient inappropriate for enrollment

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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