Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

NCT ID: NCT06134271

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2026-04-30

Brief Summary

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in hormone-sensitive prostate cancer patients with PSA progression following prior sequence therapy.

Detailed Description

This is a multicenter, prospective, cohort study to observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in patients with hormone-sensitive prostate cancer who have progressed PSA after prior sequencing therapy. Other novel endocrine or systemic regimens were used in these patients (excluding patients treated with pre-order chemotherapy alone or bicalutamide); and received ongoing gonadotropin-releasing hormone analogue (GnRHa) castration therapy (drug castration) or prior bilateral orchiectomy (surgical castration) over the course of the study; Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period.

This study included three cohorts of 160 patients with progressive metastatic hormone-sensitive prostate cancer. 56 patients were included in cohort 1, 56 patients in cohort 2 and 28 patients in cohort 3. Patients in cohort 1 were treated with rezvilutamide, 240 mg/day; Patients in cohort 2 received rezvilutamide at 240 mg/day in combination with abiraterone and hormonal therapy; Patients in cohort 3 maintained promiscuous therapy until disease progression or uncontrolled toxicity. According to PCWG3, the primary endpoint is Time to CRPC. Secondary endpoints included OS, rPFS, time to SEE, liver function assessment, and safety of NCI-TCAE 5.0.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rezvilutamide cohort

Rezvilutamide 240 mg orally once a day. Patients should also receive androgen deprivation therapy, which includes both gonadotropin releasing hormone analogue (GnRHa) castration treatment or bilateral orchiectomy.

Group Type: EXPERIMENTAL

Rezvilutamide

Intervention Type: DRUG

Rezvilutamide 240mg qd

Rezvilutamide plus abiraterone cohort

Rezvilutamide 240 mg orally once a day. Simultaneously, take orally 1000 mg of Abiraterone tablets and 5 mg of prednisone once a day. Patients should also receive androgen deprivation therapy simultaneously, that is, they should also receive gonadotropin releasing hormone analogue (GnRHa) castration treatment or have undergone bilateral orchiectomy.

Group Type: EXPERIMENTAL

Rezvilutamide plus abiraterone

Intervention Type: DRUG

Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd

Continue previous treatment cohort

Continue using the previous treatment regimen for treatment.

Group Type: EXPERIMENTAL

Continue previous treatment

Intervention Type: DRUG

Continue using the previous treatment regimen for treatment.

Interventions

Rezvilutamide

Rezvilutamide 240mg qd

Intervention Type: DRUG

Rezvilutamide plus abiraterone

Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd

Intervention Type: DRUG

Continue previous treatment

Continue using the previous treatment regimen for treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years; male;

2. Patients with pathological detection of prostate cancer and clinical diagnosis of metastatic hormone-sensitive patients with bone scanning, electronic computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET-CT) and other imaging examinations;

3. Patients with mHSPC are allowed to use other novel endocrine or systemic regimens in the pre-order (excluding those treated with chemotherapy alone or bicalutamide), castration with an ongoing gonadotropin-releasing hormone analogue (GnRHa) (drug castration), or prior bilateral orchiectomy (surgical castration); Participants who did not undergo bilateral orchiectomy had to maintain effective pharmacological castration throughout the study period;

4. PSA progression at enrollment: for patients who respond to initial therapy, PSA progression is determined if serum PSA exceeds 25% of the minimum PSA during treatment and > 0.4 ng/mL in absolute terms, and after repeated confirmation 3 weeks after the elevation is found; for patients with persistent PSA elevation after initial treatment, PSA progression is determined when the PSA elevation exceeds 25% of the baseline value and the absolute value is>0.4 ng/mL at 12 weeks of treatment;

5. The Eastern Cooperative Oncology Group（ECOG）PS of 0 or1;

6. The main organ indicators such as blood routine, coagulation function, liver and kidney function, and heart function are normal:

• ANC≥1.5×109/L；
• PLT≥100×109/L
• Hb≥90g/L；
• TBIL≤1.5×ULN；
• ALT and AST≤2.5×ULN；
• BUN（or UREC）和Cr≤1.5×ULN；
• LVEF≥50%； Volunteer to participate in this clinical trial, understand the research procedure, and have signed an informed consent form

Exclusion Criteria

1. Failure to sign an informed consent form;

2. Patients with allergic reactions to the pharmaceutical ingredients or excipients used in the study;

3. Patients with difficulty swallowing or poor digestion and absorption function；

4. Patients with severe liver function impairment (Child Pugh C grade)；

5. Confirmed by imaging, there is a brain tumor lesion; Having a history of epilepsy, or having a disease that can trigger seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization);

6. Active heart disease within the first 6 months of C1D1, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medication;

7. Suffering from any other malignant tumor within the first 5 years of C1D1 (excluding fully remitted in situ cancer and malignant tumors that have been determined by the researchers to progress slowly);

8. Have a history of immunodeficiency (including HIV testing positive, other acquired or congenital immunodeficiency diseases) or a history of organ transplantation;

9. Subjects who are unwilling to take effective contraceptive measures during the entire study treatment period and within 30 days after the last administration;

10. According to the judgment of the investigator, there are concomitant diseases (such as poorly controlled hypertension, serious diabetes, neurological or mental diseases, etc.) or any other conditions that seriously endanger the safety of patients, may confuse the research results, or affect the completion of the study by the subjects;

11. Patients participating in other clinical trial studies; After evaluation by the researcher, any other circumstances deemed unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jianbin Bi

OTHER

Sponsor Role: lead

Responsible Party

Jianbin Bi

Director of Urology Department, the First Hospital of China Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jianbin Bi

Role: STUDY_DIRECTOR

First Hospital of China Medical University

Central Contacts

Jianbin Bi

Role: CONTACT

jianbinbi@cmu.edu.cn

86+ 13998227296

Other Identifiers

FirstHCMU-JBi-RASTOM

Identifier Type: -

Identifier Source: org_study_id