Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-23
Brief Title:
Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With OlaparibAbiraterone
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With OlaparibAbiraterone Observational Study Assessing Real World Clinical Endpoints and Demographic Characteristics in Patients With Castration-resistant Prostate Cancer Treated With OlaparibAbiraterone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
PROCeed-BR
Brief Summary:
PROCeed is an observational study assessing real world clinical endpoints and demographic characteristics in patients with castration-resistant prostate cancer treated with OlaparibAbiraterone
Detailed Description:
PROCeed is an observational longitudinal study with prospective data from Brazilian participating sites so as to generate real-world data 10 Brazilian oncology sites are estimated to participate in the study Each site will have participating investigators in charge and a proper technical team who will be in charge of data from each service For this study a convenience sample will be adopted with an expected 2-year recruitment of 80 patients The protocol was created in Germany and other countries could use it with the potential for data from other countries to be pooled for analysis
Recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment at months 3 and 6 recruitment will be evaluated for proper site selection if 20 patients have only been enrolled in a particular subgroup after 1 year the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup
The study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion LPI Data will be collected from the medical record through an electronic case report form eCRF Participating physicians will be responsible for ensuring that all necessary data are collected and entered in the eCRF Data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the Academic Research Organization ARO
The target sample size of 80 patients in Brazil is based in a 24-month recruitment period In order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent a minimum enrolment of 50 40 patients of the total sample size will be imposed for this subgroup Estimation is determined based on the primary objective of the TTD event-free rate the main measure of interest is at 6 months for patients previously exposed to NHA and 12 months for patients naïve to NHA Assuming a 6- month TTD event-free rate is of approximately 50 for patients previously exposed to new hormonal agent with a sample size of 40 patients in this subgroup the precision would be - 155
Recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment at months 3 and 6 recruitment will be evaluated for proper site selection if 20 patients have only been enrolled in a particular subgroup after 1 year the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup
The study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion LPI Data will be collected from the medical record through an electronic case report form eCRF Participating physicians will be responsible for ensuring that all necessary data are collected and entered in the eCRF Data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the Academic Research Organization ARO
The target sample size of 80 patients in Brazil is based in a 24-month recruitment period In order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent a minimum enrolment of 50 40 patients of the total sample size will be imposed for this subgroup Estimation is determined based on the primary objective of the TTD event-free rate the main measure of interest is at 6 months for patients previously exposed to NHA and 12 months for patients naïve to NHA Assuming a 6- month TTD event-free rate is of approximately 50 for patients previously exposed to new hormonal agent with a sample size of 40 patients in this subgroup the precision would be - 155
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None