A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy (NCT05009290) | Clinical Trial Compass
TerminatedPhase 3
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy
Stopped: Due to the adjustment of the sponsor's development plan, after discussion with leading PI, sponsor has decided to terminate this study.
China391 participantsStarted 2021-11-01
Plain-language 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).
Who can participate
Age range18 Years
SexMALE
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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;
What they're measuring
1
pCR rate (assessed by pathology BICR)
Timeframe: 36 months since the first subject will be enrolled.
2
MFS (assessed by imaging BICR).
Timeframe: 84 months since the first subject will be enrolled.
. 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;