Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)

Exclusion Criteria

• •Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;
• •Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration, or enrolled in any other clinical studies for therapeutic purposes within 28 days prior to enrollment, or received any approved anticancer therapy within 28 days prior to enrollment;
• •Participants received local treatments of primary or metastatic lesions prior to enrollment;
• •Participants received bilateral orchiectomy prior to enrollment;
• •Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution;
• •Participants with a history of brain metastases or epilepsy;
• •Participants with severe cardiovascular disease, including: myocardial infarction or thrombosis in the previous 6 months; known unstable angina; history of documented congestive heart failure (New York Heart Association functional classification III-IV; QT interval \> 480 ms; uncontrolled hypertension defined as resting systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 105 mmHg;
• •Participants with clinically significant digestive tract abnormalities that may affect the process of drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc., or total gastrectomy);
• •Participants with other clinically significant co-morbidities evaluated by the investigator, including uncontrolled lung disease, active central nervous system disease, active or uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, or any other disease that may make the participant inappropriate for enrollment or RT + PLND after NT;
• •Participants with other known active cancers requiring treatment at the time of entry to the study, or had other malignancies within 5 years prior to enrollment;
• •Participants received surgeries other than diagnostic prostate biopsy within 4 weeks before enrollment;
• •Participants with active or known human immunodeficiency virus (HIV) with detectable viral load; active hepatitis B, defined as positive HBV DNA viral load or as defined by relevant guidelines; hepatitis C virus (HCV), except for those have been treated and have an undetectable viral load;
• •Participants with a history of non-compliance to medical regimen or inappropriate for the study, attributed to not meeting the principle of optimal benefit treatment.