Rezvilutamide for High-Risk Prostate Cancer After Surgery

Korábbi kezelés

• Factors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
• History of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization).
• Active cardiac disease within 6 months prior to screening, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment.
• Male subjects with female partners of childbearing potential who refuse surgical sterilization or refuse to use effective contraception during the study period.

Más betegség

• Known or suspected hypersensitivity to Rezvilutamide or any of its excipients.
• History of other malignancies within 3 years prior to screening (except for completely remitted carcinoma in situ or malignancies judged by the investigator to be slow-progressing).
• Active HBV or HCV infection (HBV DNA ≥ 10\^4 copies/mL, HCV RNA ≥ 10\^3 copies/mL).
• History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation.
• Any other condition which, in the opinion of the investigator, may interfere with the conduct of the study, compromise protocol compliance, or pose an unacceptable risk to the subject.

Egyéb

• Patients meeting any of the following criteria will be excluded from the study:
• Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features.

• Subjects must meet all of the following criteria to be eligible for entry into this study:
• Age ≥ 18 years.
• Histologically confirmed adenocarcinoma of the prostate following radical prostatectomy.
• Evaluated by the investigator as requiring pharmacological treatment.
• ECOG Performance Status of 0 or 1.
• Preoperative imaging ruled out metastatic disease.
• Must meet at least one of the following postoperative high-risk factors:
• Positive surgical margins;
• Pathological stage pT3-pT4;
• Lymph node metastasis;
• Preoperative PSA ≥ 20 ng/ml.
• Unwilling to receive postoperative radiotherapy.
• PSA \< 0.1 ng/ml during the screening period.
• Capable of understanding and voluntarily signing the Informed Consent Form (ICF).