Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

NCT06134271 | Not Yet Recruiting Phase 2

• 1 other identifier: FirstHCMU-JBi-RASTOM
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Keywords

prostate cancer; rezvilutamide; abiraterone

Outcome Measures

Primary Outcomes (1)

• Time to castration-resistant prostate cancer (CRPC)

  The time reach CRPC is defined as the occurrence of the following events, whichever occurs first, serum PSA progression: PSA value\>2 ng/ml, interval of 1 week, consecutive 2 times, increase\>50% from baseline, serum testosterone at castrated level (\<50 ng/dL or 1.7 nmol/L) or soft tissue, visceral imaging progression or bone injury (following the recommendations of Prostate Cancer Clinical Trial Working Group 3 \[PCWG3\]); Imaging progression of soft tissue/visceral lesions based on magnetic resonance imaging (MRI)/computed tomography (CT) performed by researchers on the chest, abdomen, and pelvis (based on RECIST 1.1).

  From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months.

Secondary Outcomes (5)

• Overall survival (OS)

  From the first day of patient enrollment to all-cause mortality, the duration of the assessment should not exceed 24 months.

• Radiographic Progression-free survival (rPFS)

  From the first day of patient enrollment to the time reach radiographic progression, the duration of the assessment should not exceed 24 months.

• Time to first Symptomatic Skeletal Event (SSE)

  From the first day of patient enrollment to the occurrence of the SSE, the duration of the assessment should not exceed 24 months.

• Liver function assessment

  From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months

• Safety profile

  From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months

Study Arms (3)

Rezvilutamide cohort

EXPERIMENTAL

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.

Drug: Rezvilutamide

Rezvilutamide plus abiraterone cohort

EXPERIMENTAL

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.

Drug: Rezvilutamide plus abiraterone

Continue previous treatment cohort

EXPERIMENTAL

Continue using the previous treatment regimen for treatment.

Drug: Continue previous treatment

Interventions

Rezvilutamide DRUG

Rezvilutamide 240mg qd

Rezvilutamide cohort

Rezvilutamide plus abiraterone DRUG

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

Rezvilutamide plus abiraterone cohort

Continue previous treatment DRUG

Continue using the previous treatment regimen for treatment.

Continue previous treatment cohort

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years; male;
• 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;
• 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;
• 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;
• The Eastern Cooperative Oncology Group（ECOG）PS of 0 or1;
• 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

You may not qualify if:

• Failure to sign an informed consent form;
• Patients with allergic reactions to the pharmaceutical ingredients or excipients used in the study;
• Patients with difficulty swallowing or poor digestion and absorption function；
• Patients with severe liver function impairment (Child Pugh C grade)；
• 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);
• 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;
• 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);
• Have a history of immunodeficiency (including HIV testing positive, other acquired or congenital immunodeficiency diseases) or a history of organ transplantation;
• Subjects who are unwilling to take effective contraceptive measures during the entire study treatment period and within 30 days after the last administration;
• 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;
• Patients participating in other clinical trial studies; After evaluation by the researcher, any other circumstances deemed unsuitable for participation in this study.

Sponsors & Collaborators

• Jianbin Bi: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jianbin Bi

  First Hospital of China Medical University

  STUDY DIRECTOR

Central Study Contacts

Jianbin Bi

CONTACT

86+ 13998227296; jianbinbi@cmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Urology Department, the First Hospital of China Medical University

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 18, 2023
• Study Start: November 15, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share