Rezvilutamide for High-Risk Prostate Cancer After Surgery

NCT07444983 | Not Yet Recruiting DMC

• 1 other identifier: 2025KY291
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 3-year Biochemical Recurrence-Free Survival (BCRFS) Rate.

  Up to 36 months post-enrollment.

Study Arms (1)

Rezvilutamide plus ADT (Leuprorelin)

EXPERIMENTAL

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

Interventions

Rezvilutamide and Leuprorelin DRUG

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.

Rezvilutamide plus ADT (Leuprorelin)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Department of Urology, Fujian Union Hospital, Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mengqiang Li

  Department of Urology, Fujian Union Hospital, Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiabing Zheng

CONTACT

+8613799422519; xhyykjk@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): July 11, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)