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This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezvilutamide Tablets Group | Experimental |
| |
| Enzalutamide Soft Capsules Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezvilutamide Tablets | Drug | Rezvilutamide tablets, oral administration. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Specific Antigen (PSA) undetectable rate based on central laboratory. | Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in central laboratory testing within 6 months after randomization. | 6 months after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate based on local laboratory. | Defined as the proportion of subjects who achieved a ≥50% or ≥90% reduction in PSA levels from baseline among those who had not initiated ADT treatment prior to randomization. | Up to approximately 5 years. |
| PSA undetectable rate based on local laboratory. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daomin Hu | Contact | +86-0518-82342973 | hudaomin@aidiyan.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Medical Center of the Chinese People's Liberation Army (PLA) General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Enzalutamide Soft Capsules |
| Drug |
Enzalutamide soft capsules, oral administration. |
|
Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in local laboratory within 6 months after randomization. |
| 6 months after randomization. |
| 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 and PCWG3. | Up to approximately 5 years. |
| Radiographic progression-free survival (rPFS). | Time from randomisation to radiologically confirmed progressive disease or death due to any cause. | Up to approximately 5 years. |
| Time to PSA progression based on local laboratory. | Time from randomisation to the first time of PSA progression according to the criterion of PCGW3. | Up to approximately 5 years. |
| Time to castration-resistant prostate cancer (CRPC). | Defined as the time from randomization to the first occurrence of castration-resistant event. | Up to approximately 5 years. |
| Overall survival (OS). | Defined as the time from randomization to death due to any cause. | Up to approximately 5 years. |
| Adverse events (AEs). | An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to approximately 5 years. |