Rezvilutamide for High-Risk Prostate Cancer After Surgery

What Was Tested

In this not phased trial, researchers set out to test Leuprolide.

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?

It had 1 arm (groups): Rezvilutamide plus ADT (Leuprorelin) (experimental).

The registry classes the interventions as drug.

More on the Plan

\[Study Rationale \& Background\] 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.

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.

Each treatment cycle lasts 28 days.

Who Took Part

Enrollment: 33 planned participants were the target.

It was open to men only aged from 18 years up to 95 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-02-11 with completion listed for 2027-02-11.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 3-year Biochemical Recurrence-Free Survival (BCRFS) Rate (time frame: Up to 36 months post-enrollment).

What This Means in Plain Language

Put simply, this is a not phased trial of Leuprolide in 33 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.