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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 391
- Locations
- 1
- Primary Endpoint
- pCR rate (assessed by pathology BICR)
- Status
- Terminated
- Last Updated
- 29 days ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Treatment group : Placebo + ADT
Intervention: Placebo
Treatment group：SHR3680 + ADT
Intervention: SHR3680
Outcomes
Primary Outcomes
pCR rate (assessed by pathology BICR)
Time Frame: 36 months since the first subject will be enrolled.
Defined as the proportion of subjects with no residual tumor detected in prostatectomy specimens by H\&E staining and ancillary immunohistochemistry (if necessary) as assessed by pathology BICR.
MFS (assessed by imaging BICR).
Time Frame: 84 months since the first subject will be enrolled.
Defined as the time from the date of randomization to the date of first occurrence of BICR-confirmed radiographic distant metastasis, accidental pathologic finding of distant metastasis, or death from any cause (whichever occurs first), regardless of whether the subject reveives any other anti-tumor therapy or has missing (or unevaluable) tumor assessments.
Secondary Outcomes
- MFS (investigator-assessed).(84 months since the first subject will be enrolled.)
- PSA response rate.(25 months since the first subject will be enrolled.)
- PSM rate.(31 months since the first subject will be enrolled.)
- Time to BCR.(42 months since the first subject will be enrolled.)