A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
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
Jiangsu HengRui Medicine Co., Ltd.
1,256 participants
Nov 1, 2021
INTERVENTIONAL
Conditions
Summary
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 Criteria6
- Age of ≥ 18 years old;
- ECOG PS score of 0 or 1;
- Pathologically diagnosed as prostate adenocarcinoma;
- High-risk patients
- No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations;
- Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy);
Exclusion Criteria6
- 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;
- Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization;
- Subjects who are planning bilateral orchidectomy during the treatment period of the study;
- Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption;
- 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);
- 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;
Interventions
Treatment group: SHR3680 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy). Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.
Treatment group ：Placebo 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy). Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05009290