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Rezvilutamide for High-Risk Prostate Cancer After Surgery

NCT07444983 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Rezvilutamide works to treat high-risk prostate cancer in patients who have recently undergone surgery (radical prostatectomy). It will also learn about the safety of Rezvilutamide. The main questions it aims to answer are:

Does Rezvilutamide, when used as an add-on treatment after surgery, lower the risk of the cancer returning (biochemical recurrence) within 3 years? What is the 36-month metastasis-free survival (MFS) rate for patients receiving this treatment? What is the safety profile of Rezvilutamide combined with ADT, specifically regarding the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs), and rare adverse events? What are the exploratory findings regarding the status of immune cells after using Rezvilutamide?

Researchers will evaluate the combination of Rezvilutamide and hormone therapy (ADT) to see if it helps keep patients cancer-free.

Participants will:

Take Rezvilutamide: 240 mg once daily, taken orally before or after breakfast. Each cycle is 28 days, for up to 24 cycles. Treatment continues unless biochemical recurrence, disease progression, intolerable toxicity occurs, or the participant withdraws consent, as determined by the investigator.

Receive Androgen Deprivation Therapy (ADT): Leuprorelin 3.75mg via subcutaneous injection, once every 28 days for a total of 12 cycles.

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

DRUG

Rezvilutamide and Leuprorelin

Combination Phase (Cycles 1-12): Rezvilutamide 240 mg orally once daily, combined with Leuprorelin 3.75 mg via subcutaneous injection every 28 days. Maintenance Phase (Cycles 13-24): Rezvilutamide 240 mg orally once daily as monotherapy. Duration: Each cycle is 28 days. The total treatment duration is up to 24 cycles (approximately 2 years). This study specifically focuses on the adjuvant intensive endocrine therapy for high-risk patients following radical prostatectomy.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • Mengqiang Li · Department of Urology, Fujian Union Hospital, Fujian Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-11
Primary Completion
2027-02-11
Completion
2029-07-11

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07444983 on ClinicalTrials.gov