Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652607
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer and Analysis of Baseline Characteristics Between Patients With or Without PSA Value of 02 ngdl
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSA-DEEP02
Brief Summary:
Prostate cancer remains the most common malignancy in men in Europe Over the last two decades the treatment landscape for both localized and metastatic prostate cancer has been revolutionized For patients with metastatic castration-sensitive prostate cancer mCSPC the primary treatment objectives are to delay progression to metastatic castration-resistant prostate cancer mCRPC and to improve overall survival OS Although patients with PC may initially respond to androgen deprivation therapy ADT progression to castration resistance occurs in 10-20 of patients within 5 years
Primary ADT has been the standard of care for over 50 years However recent advancements have shifted treatment from ADT monotherapy for all mHSPCmCRPC patients to more intensive approaches which include combinations of ADT with new androgen receptor pathway inhibitors ARPIs chemotherapy or both tailored to tumor characteristics such as metastatic burden
In clinical practice a reduction in prostatic specific antigen PSA levels from baseline is commonly used to monitor disease control particularly in the castration sensitive phase both early and metastatic For patients with mCSPC a decrease in PSA levels signifies that the treatment is effective Moreover the depth time and duration of this PSA reduction are linked to better clinical outcomes including OS Although more patients achieved an optimal PSA response with intensified ADT with ARPI or docetaxel those with a suboptimal response have a significantly worse survival rate Several key studies have demonstrated that achieving undetectable PSA 02 ngmL is associated with better OS irrespective of subgroups
This study aims to evaluate patient survival based on PSA response and to describe baseline characteristics among patients with or without PSA response Specifically patients will be divided into two groups based on the achievement of PSA values 02 ngdl and overall survival OS and progression free survival PFS for each group will be evaluated Clinical and laboratory information at baseline will be compared between the two groups Baseline characteristics considered are histology Gleason score stage of disease presence of genetic alterations PSA values sites and number of metastases de novo or metachronous disease highlow risk disease highlow volume disease
Primary ADT has been the standard of care for over 50 years However recent advancements have shifted treatment from ADT monotherapy for all mHSPCmCRPC patients to more intensive approaches which include combinations of ADT with new androgen receptor pathway inhibitors ARPIs chemotherapy or both tailored to tumor characteristics such as metastatic burden
In clinical practice a reduction in prostatic specific antigen PSA levels from baseline is commonly used to monitor disease control particularly in the castration sensitive phase both early and metastatic For patients with mCSPC a decrease in PSA levels signifies that the treatment is effective Moreover the depth time and duration of this PSA reduction are linked to better clinical outcomes including OS Although more patients achieved an optimal PSA response with intensified ADT with ARPI or docetaxel those with a suboptimal response have a significantly worse survival rate Several key studies have demonstrated that achieving undetectable PSA 02 ngmL is associated with better OS irrespective of subgroups
This study aims to evaluate patient survival based on PSA response and to describe baseline characteristics among patients with or without PSA response Specifically patients will be divided into two groups based on the achievement of PSA values 02 ngdl and overall survival OS and progression free survival PFS for each group will be evaluated Clinical and laboratory information at baseline will be compared between the two groups Baseline characteristics considered are histology Gleason score stage of disease presence of genetic alterations PSA values sites and number of metastases de novo or metachronous disease highlow risk disease highlow volume disease
Detailed Description:
None
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