Trials / Unknown
UnknownNCT03520478
A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 654 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.
Detailed description
This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR3680 | Tablet. Specifications of 80 mg; orally, once a day |
| DRUG | Bicalutamide | Tablet. Specifications of 50 mg; orally, once a day |
Timeline
- Start date
- 2018-05-30
- Primary completion
- 2023-04-30
- Completion
- 2025-04-30
- First posted
- 2018-05-09
- Last updated
- 2021-03-02
Locations
67 sites across 4 countries: Bulgaria, China, Czechia, Poland
Source: ClinicalTrials.gov record NCT03520478. Inclusion in this directory is not an endorsement.