RecruitingPhase 3NCT05009290

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

1,256 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called SHR3680 (a type of androgen receptor blocker) given before surgery in men with high-risk localized prostate cancer, to see if it improves outcomes compared to surgery alone. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of prostate cancer (adenocarcinoma) - Your cancer is classified as high-risk and has not spread to other organs (no distant metastases) - You are scheduled to have radical prostatectomy (complete prostate removal with lymph node dissection) - You have received little or no prior treatment for prostate cancer **You may NOT be eligible if...** - You have received significant prior prostate cancer treatment (other than short-term hormone therapy or androgen blockers for up to 4 weeks) - Your cancer has spread to distant organs - You have had major surgery or another investigational drug within 4 weeks of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR3680

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.

DRUGPlacebo

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.


Locations(1)

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, China

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NCT05009290