Rezvilutamide for High-Risk Prostate Cancer After Surgery

March 2, 2026 updated by: Fujian Medical University Union Hospital

An Exploratory Clinical Study of Rezvilutamide as Adjuvant Therapy for High-Risk Patients After Radical Prostatectomy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

[Study Rationale & Background] High-risk prostate cancer is typically defined by factors including clinical stage (e.g., cT3-4), a Gleason score of 8 or higher, and Prostate-Specific Antigen (PSA) levels greater than 20 ng/mL. Patients meeting these criteria face a significant risk of recurrence after radical prostatectomy (RP). While adjuvant radiotherapy is a standard option, many patients cannot tolerate or choose not to undergo radiation. This study explores an intensive endocrine therapy approach using Rezvilutamide, a potent new-generation oral androgen receptor (AR) inhibitor, combined with standard Androgen Deprivation Therapy (ADT).

[Study Design & Intervention] This is an exploratory, prospective, single-arm clinical study. After enrollment, participants will receive a combination therapy of standard-dose Rezvilutamide (240 mg once daily, orally) and ADT (Leuprorelin 3.75 mg subcutaneous injection, once every 4 weeks). Each treatment cycle lasts 28 days. After completing 12 cycles of the combination therapy, participants will proceed to monotherapy with standard-dose Rezvilutamide for maintenance. The total duration of treatment will be up to 24 cycles. The primary objective is to evaluate the 3-year biochemical recurrence-free survival (BCRFS) rate.

[Safety & Exploratory Objectives] Secondary objectives focus on the 36-month metastasis-free survival (MFS) rate and a comprehensive safety profile. This includes monitoring the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Adverse Events of Special Interest (AESIs). Additionally, the study includes an exploratory analysis of immune cell status to characterize the biological impact of Rezvilutamide on the patient's immune environment during treatment.

[Quality of Life] Patient-reported outcomes and quality of life will be monitored throughout the study using standardized assessment tools, including the FACT-P, EPIC-26, and BPI-SF scales, to ensure a holistic evaluation of the treatment's impact on physical and emotional well-being.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Department of Urology, Fujian Union Hospital, Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Subjects must meet all of the following criteria to be eligible for entry into this study:

Age ≥ 18 years.

Histologically confirmed adenocarcinoma of the prostate following radical prostatectomy.

Evaluated by the investigator as requiring pharmacological treatment.

ECOG Performance Status of 0 or 1.

Preoperative imaging ruled out metastatic disease.

Must meet at least one of the following postoperative high-risk factors:

Positive surgical margins;

Pathological stage pT3-pT4;

Lymph node metastasis;

Preoperative PSA ≥ 20 ng/ml.

Unwilling to receive postoperative radiotherapy.

PSA < 0.1 ng/ml during the screening period.

Capable of understanding and voluntarily signing the Informed Consent Form (ICF).

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features.

Known or suspected hypersensitivity to Rezvilutamide or any of its excipients.

Factors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.

History of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization).

Active cardiac disease within 6 months prior to screening, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment.

History of other malignancies within 3 years prior to screening (except for completely remitted carcinoma in situ or malignancies judged by the investigator to be slow-progressing).

Active HBV or HCV infection (HBV DNA ≥ 10^4 copies/mL, HCV RNA ≥ 10^3 copies/mL).

History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation.

Male subjects with female partners of childbearing potential who refuse surgical sterilization or refuse to use effective contraception during the study period.

Any other condition which, in the opinion of the investigator, may interfere with the conduct of the study, compromise protocol compliance, or pose an unacceptable risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rezvilutamide plus ADT (Leuprorelin)
Participants will receive Rezvilutamide (240 mg daily) plus ADT (Leuprorelin 3.75mg every 28 days) for 12 cycles, followed by Rezvilutamide monotherapy (240 mg daily) for up to 12 additional cycles. The total treatment duration is up to 24 cycles.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-year Biochemical Recurrence-Free Survival (BCRFS) Rate.
Time Frame: Up to 36 months post-enrollment.
Up to 36 months post-enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Investigators

  • Principal Investigator: Mengqiang Li, Department of Urology, Fujian Union Hospital, Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 11, 2026

Primary Completion (Estimated)

February 11, 2027

Study Completion (Estimated)

July 11, 2029

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KY291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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