Other Clinical Trial - A Trial of SHR3680 in Prostate Cancer Patients Who

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

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

Official title:
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

Clinical Trial 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).

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05009290
Study type	Interventional
Source	Jiangsu HengRui Medicine Co., Ltd.
Contact	Chunlei Jin, M.D.
Phone	+86-18036618079
Email	chunlei.jin@hengrui.com
Status	Recruiting
Phase	Phase 3
Start date	November 1, 2021
Completion date	October 30, 2031

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms