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
Who is this study for? Patients with Prostate Cancer
What treatments are being studied? SHR3680
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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);
Locations
Other Locations
China
Fudan University Shanghai Cancer center
RECRUITING
Shanghai
Contact Information
Primary
Chunlei Jin, M.D.
chunlei.jin@hengrui.com
+86-18036618079
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2031-10-30
Participants
Target number of participants: 1256
Treatments
Experimental: Treatment group：SHR3680 + ADT
Placebo_comparator: Treatment group : Placebo + ADT
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.