A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;
Age ≥ 18 years;
Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;
Metastatic hormone sensitive prostate cancer;
Disqualifiers
Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;
Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;
Total PSA has decreased to undetectable levels at baseline;
Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;
Trial design
Design model
Parallel
Treatments tested in this trial
Rezvilutamide Tablets
DrugRezvilutamide tablets, oral administration.
Enzalutamide Soft Capsules
DrugEnzalutamide soft capsules, oral administration.
Treatment groups
206 Participants
are divided into 2 treatment groupsGroup A: Rezvilutamide Tablets GroupExperimental treatment 1 intervention
Group B: Enzalutamide Soft Capsules GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months after randomization.Secondary outcomes
1
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.
Time frame
Up to approximately 5 years.2
PSA undetectable rate based on local laboratory.
Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in local laboratory within 6 months after randomization.
Time frame
6 months after randomization.3
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.
Time frame
Up to approximately 5 years.4
Radiographic progression-free survival (rPFS).
Time from randomisation to radiologically confirmed progressive disease or death due to any cause.
Time frame
Up to approximately 5 years.Sponsors and contacts
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Source ClinicalTrials.gov