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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Not Yet Recruiting PHASE2 INTERVENTIONAL NCT06134271

Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in hormone-sensitive prostate cancer patients with PSA progression following prior sequence therapy.

Detailed Description

This is a multicenter, prospective, cohort study to observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in patients with hormone-sensitive prostate cancer who have progressed PSA after prior sequencing therapy. Other novel endocrine or systemic regimens were used in these patients (excluding patients treated with pre-order chemotherapy alone or bicalutamide); and received ongoing gonadotropin-releasing hormone analogue (GnRHa) castration therapy (drug castration) or prior bilateral orchiectomy (surgical castration) over the course of the study; Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period. This study included three cohorts of 160 patients with progressive metastatic hormone-sensitive prostate cancer. 56 patients were included in cohort 1, 56 patients in cohort 2 and 28 patients in cohort 3. Patients in cohort 1 were treated with rezvilutamide, 240 mg/day; Patients in cohort 2 received rezvilutamide at 240 mg/day in combination with abiraterone and hormonal therapy; Patients in cohort 3 maintained promiscuous therapy until disease progression or uncontrolled toxicity. According to PCWG3, the primary endpoint is Time to CRPC. Secondary endpoints included OS, rPFS, time to SEE, liver function assessment, and safety of NCI-TCAE 5.0.

Interventions

Name: Rezvilutamide
Type: DRUG
Description: Rezvilutamide 240mg qd
Name: Rezvilutamide plus abiraterone
Type: DRUG
Description: Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd
Name: Continue previous treatment
Type: DRUG
Description: Continue using the previous treatment regimen for treatment.

Primary Outcomes

Measure: Time to castration-resistant prostate cancer (CRPC)
TimeFrame: From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months.
Description: The time reach CRPC is defined as the occurrence of the following events, whichever occurs first, serum PSA progression: PSA value\>2 ng/ml, interval of 1 week, consecutive 2 times, increase\>50% from baseline, serum testosterone at castrated level (\<50 ng/dL or 1.7 nmol/L) or soft tissue, visceral imaging progression or bone injury (following the recommendations of Prostate Cancer Clinical Trial Working Group 3 \[PCWG3\]); Imaging progression of soft tissue/visceral lesions based on magnetic resonance imaging (MRI)/computed tomography (CT) performed by researchers on the chest, abdomen, and pelvis (based on RECIST 1.1).

Trial Information

NCT ID

NCT06134271

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Jianbin Bi

Last Updated

December 15, 2025