Evaluating SHR3680 for Prostate Cancer Patients Before Surgery

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of SHR3680 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Patients With High-Risk Localized or Locally Advanced Prostate Cancer Undergoing Radical Prostatectomy

This study is testing if a new drug called SHR3680, used with standard hormone therapy, can help men with high-risk prostate cancer do better before their surgery compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1256 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05009290 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR3680 in combination with androgen deprivation therapy (ADT) compared to a placebo plus ADT in patients diagnosed with high-risk localized or locally advanced prostate cancer. The study focuses on measuring the pathologic complete response (pCR) rate and metastasis-free survival (MFS) in participants who are candidates for radical prostatectomy. Eligible patients will be closely monitored throughout the trial to determine the effectiveness of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with high-risk localized or locally advanced prostate cancer who are planning to undergo radical prostatectomy.

Not a fit: Patients with distant metastasis or those who have received prior treatments for prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk prostate cancer by enhancing response rates before surgery.

How similar studies have performed: Other studies have shown promise in using similar approaches for treating high-risk prostate cancer, indicating potential for success.

Eligibility criteria

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;

Where this trial is running

Shanghai, Shanghai

• Fudan University Shanghai Cancer center — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Chunlei Jin, M.D.

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