MedTrace Logo

Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy

NCT07711314 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-23

No results posted yet for this study

Summary

Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of \< 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.

Conditions

  • Prostate Cancer (Post Prostatectomy)

Interventions

DRUG

Rezvilutamide Tablets

Patients will receive rezvilutamide monotherapy orally at a dose of 240 mg (three 80 mg tablets) once daily. The medication must be swallowed whole and can be taken with or without food. Treatment is initiated between 4 to 12 weeks following radical prostatectomy and continues for 12 consecutive 28-day cycles (totaling 48 weeks). Unlike standard adjuvant regimens or previous metastatic trials that combine novel hormone agents with traditional androgen deprivation therapy (ADT), this study evaluates rezvilutamide strictly as a single-agent therapy. It specifically targets patients with localized prostate cancer who have achieved a postoperative PSA \< 0.1 ng/mL but have a high risk of recurrence (CAPRA-S score ≥ 6). If patients experience ≥ Grade 3 or intolerable toxicity, the dose may be interrupted and subsequently reduced to 160 mg or 80 mg daily.

Sponsors & Collaborators

  • Shengli Oilfield Hospital

    collaborator OTHER

  • The Second Hospital of Anhui Medical University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-05-31
Completion
2030-05-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07711314 on ClinicalTrials.gov