Overview

The study is being conducted to evaluate the efficacy and safety of SHR3680 plus androgen deprivation therapy (ADT) vs. placebo plus ADT in patients with high-risk localized or locally advanced prostate cancer using pathologic complete response (pCR) rate and metastasis-free survival (MFS).

Eligibility

Inclusion Criteria:

1. Age of ≥ 18 years old;
2. ECOG PS score of 0 or 1;
3. Pathologically diagnosed as prostate adenocarcinoma;
4. High-risk patients
5. No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
6. Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);

Exclusion Criteria:

1. Subjects who received any prior treatment for prostate cancer, except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks;
2. Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
3. Subjects who are planning bilateral orchidectomy during the treatment period of the study;
4. Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
5. Subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization);
6. Subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;