NCT05009290

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	SHR3680	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.
DRUG	Placebo	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2021-08-17
• Last updated: 2026-04-03

Locations

1 site across 1 country: China