Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134271
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-10-29
Brief Title:
Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer
Sponsor:
Jianbin Bi
Organization:
First Hospital of China Medical University
Study Overview
Official Title:
A Multicenter Prospective Cohort Study on the Treatment of Metastatic Hormone-sensitive Prostate Cancer Patients Who Have Progressed After Pre-treatment With Rezvilutamide Combined With Abiraterone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RASTOM
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 mgday Patients in cohort 2 received rezvilutamide at 240 mgday 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 50
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 mgday Patients in cohort 2 received rezvilutamide at 240 mgday 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 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None