Rezvilutamide versus enzalutamide for low-volume metastatic hormone-sensitive prostate cancer

A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy (ADT) Versus Enzalutamide Combined With ADT for Treating Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

This Phase III trial tests whether rezvilutamide works as well as or better than enzalutamide for men with low-volume metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07241416 on ClinicalTrials.gov

What this trial studies

This Phase III comparison gives eligible men either rezvilutamide tablets or enzalutamide capsules while they continue standard androgen-deprivation therapy (ADT). The study compares disease control and safety between the two oral androgen-receptor inhibitors in patients with low-volume metastatic hormone-sensitive prostate cancer and ECOG performance status 0–1. Participants must have prostate adenocarcinoma without neuroendocrine or small cell features and meet predefined organ function and contraceptive requirements. The trial is sponsored by Jiangsu HengRui Medicine and is being conducted at The First Medical Center of the PLA General Hospital in Beijing.

Who should consider this trial

Good fit: Men aged 18 or older with histologically confirmed low-volume metastatic hormone-sensitive prostate adenocarcinoma, ECOG 0–1, planned to receive and maintain ADT, with adequate organ function and willingness to follow contraception rules are ideal candidates.

Not a fit: Patients who have already received prior ADT for metastatic disease, prior chemotherapy or prior AR-targeted therapies, those with neuroendocrine or small-cell features, or those with poor organ function or performance status are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, rezvilutamide could provide an alternative oral hormone therapy with similar or improved cancer control and a comparable or better side-effect profile than enzalutamide.

How similar studies have performed: Other androgen-receptor inhibitors such as enzalutamide, apalutamide, and darolutamide have shown benefit in hormone-sensitive prostate cancer, so this class approach has proven efficacy while rezvilutamide itself is still being established.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;
2. Age ≥ 18 years;
3. Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;
4. Metastatic hormone sensitive prostate cancer;
5. ECOG PS: 0-1;
6. Planned to receive and maintain ADT during the study period;
7. Adequate hepatic, renal, heart, and hematological functions;
8. Determined by the investigator to be able to comply with the study protocol;
9. Fertile subjects must use effective contraception or abstain from sexual activity and sperm donation until 3 months after last exposure to rezvilutamide or enzalutamide. Subjects must use condoms plus an additional effective contraceptive method during sexual activity with a fertile female partner throughout treatment and for 3 months post-treatment.

Exclusion Criteria:

1. Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;
2. Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;
3. Total PSA has decreased to undetectable levels at baseline;
4. Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;
5. Planned to initiate any other anti-tumor therapies during the study;
6. Known history of hypersensitivity to rezvilutamide, enzalutamide, or any of their components;
7. Unable to swallow, chronic diarrhea or intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
8. History of seizure or certain conditions that may predispose to seizure;
9. Presence of clinically significant cardiovascular diseases within 6 months prior to randomization;
10. Any other malignancy within 5 years prior to randomization (except as specifically allowed by the protocol);
11. Active HBV or HCV infection;
12. History of immunodeficiency (including HIV-positive status, other acquired or congenital immunodeficiency disorders) or organ transplantation;
13. Any concomitant condition that, in the opinion of the investigator, would seriously jeopardize patient safety, confound study findings, or compromise the patient's ability to complete the study (e.g., hypertension inadequately controlled despite medication, severe diabetes, neurologic or psychiatric disorders, etc.) or any other circumstance.

Where this trial is running

Beijing, Beijing Municipality

• The First Medical Center of the Chinese People's Liberation Army (PLA) General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Daomin Hu

Conditions: Metastatic Hormone-sensitive Prostate Cancer