A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Treatments: Drug: Placebo; Drug: SHR3680

Study type: Interventional

Funder types: Industry

Identifiers

NCT05009290

SHR3680-III-302

Details and patient eligibility

About

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).

Enrollment: 1,256 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,256 participants in 2 patient groups, including a placebo group

Treatment group：SHR3680 + ADT

Experimental group

Treatment:

Drug: SHR3680

Treatment group : Placebo + ADT

Placebo Comparator group

Treatment:

Drug: Placebo