A Phase 2 interventional study of Rezvilutamide and Rezvilutamide plus abiraterone in Metastatic Hormone-Sensitive Prostate Cancer, sponsored by Jianbin Bi. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Jianbin Bi · Phase 2, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 160 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Jianbin Bi is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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The main organ indicators such as blood routine, coagulation function, liver and kidney function, and heart function are normal:
Exclusion Criteria:
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 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 using the previous treatment regimen for treatment.
Drug: Continue previous treatment
Rezvilutamide 240mg qd
Rezvilutamide 240mg qd plus abiraterone 1000mg + prednisone 5 mg qd
Continue using the previous treatment regimen for treatment.
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).
Time frame: From the first day of patient enrollment until the time reach CRPC, the duration of the assessment should not exceed 24 months.
Overall survival (OS)
Overall survival is defined as the time from the first day of enrollment to the patient's death due to any cause.
Time frame: 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)
The radiographic progression free survival is defined as the time from the first day of patient enrollment to imaging progression or death. Imaging progress includes progress under bone scanning, where at least 2 new lesions are discovered under bone scanning, or measurable soft tissue lesions are detected under computed tomography (CT) or magnetic resonance imaging (MRI) (based on the definition of the Solid Tumor Response Evaluation Standard (RECIST) version 1.1). According to RECIST 1.1 guidelines, progression requires a 20% increase in the sum of all target lesion diameters, and an absolute minimum sum increase of 5 millimeters (mm) compared to the sum of the lowest values.
Time frame: 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)
Symptomatic Skeletal Event (SSE) is defined as the occurrence of the following events, including fractures, spinal cord compression, bone specific radiotherapy or surgery, and death from any cause, whichever occurs first.radiotherapy or surgery for bones, death for all cause, whichever occurs first.
Time frame: 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
Liver function will be assessed once every 2 weeks in the first three cycles, once every 4 weeks in the continues treatment.
Time frame: From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months
Safety profile
Any adverse events were recorded starting from the first administration of riviramide or the combination of riviramide and abiolone until the end of the safety follow-up period.Among them, liver function assessment is conducted in the first 3 cycles, once every 2 weeks; Subsequent treatment should be conducted once every 4 weeks.
Time frame: From the first day of patient enrollment to the end of treatment, the evaluation duration should not exceed 24 months
No study locations are listed for this record.
Plan to share: No
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