A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer

Conditions
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Prostate Cancer, Hormone-Dependent Prostate Cancer

Intervention / Treatment
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* Drug: SHR3680
* Drug: Bicalutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≧18 year, male; ECOG performance scale 0 to 1; Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ; Adequate hepatic, renal, heart, and hematological functions; Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1; Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens; Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ; Evidence of brain metastasis or primary tumors; Planned to initiate any other anti-tumor therapies during the study; Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases; History of seizure or certain conditions that may predispose to seizure; Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR3680<br>Participants will receive SHR3680 orally | Drug: SHR3680<br>* Tablet. Specifications of 80 mg; orally, once a day<br>|
| Active Comparator: bicalutamide<br>Participants will receive bicalutamide orally | Drug: Bicalutamide<br>* Tablet. Specifications of 50 mg; orally, once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rPFS | Time from randomisation to radiologically confirmed progressive disease or death due to any cause | Approximately 70 months | 
| OS | Time from randomisation to death due to any cause | Approximately 70 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to prostate specific antigen (PSA) progression | Time from randomisation to the first time of PSA progression according to the criterion of PCGW3 | Approximately 70 months | 
| Time to skeletal-related events | Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery | Approximately 70 months | 
| Objective response rate (ORR) | The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria | Approximately 70 months | 
| Time to initiation of a new antineoplastic therapy | Time from randomisation to the initiation of antineoplastic subsequent to the study treatment | Approximately 70 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone sensitive prostate cancer, SHR3680, Anti-androgen receptor