A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical Prostatectomy

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,256

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

October 30, 2027

Study Completion Date

October 30, 2031

Conditions
Patients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Interventions
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."

Trial Locations (1)

Unknown

RECRUITING

Fudan University Shanghai Cancer center, Shanghai

All Listed Sponsors
lead

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY