Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398639
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-28
Brief Title:
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Sponsor:
Adam S Kibel MD
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PRS
Brief Summary:
The goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer This clinical trial is using genetic data to determine a mans risk of cancer together with multiparametric magnetic resonance imaging mpMRI to identify men with higher grade cancer
The main questions it aims to answer are
If genetic data related to prostate cancer used with MRI can identify higher-grade potentially fatal prostate cancer
What age a MRI is useful clinically for prostate cancer screening
If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers
Participants will
Get a prostate specific antigen PSA blood test
Get an mpMRI
Get the results of their genetic data to determine if they are considered high- intermediate- or low-risk for prostate cancer based on the trials genetic testing
Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
The main questions it aims to answer are
If genetic data related to prostate cancer used with MRI can identify higher-grade potentially fatal prostate cancer
What age a MRI is useful clinically for prostate cancer screening
If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers
Participants will
Get a prostate specific antigen PSA blood test
Get an mpMRI
Get the results of their genetic data to determine if they are considered high- intermediate- or low-risk for prostate cancer based on the trials genetic testing
Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
Detailed Description:
Background
Prostate cancer is the most commonly diagnosed cancer among men in the United States
Prostate cancer screening using the marker prostate-specific antigen PSA is controversial
PSA based screening is less effective at least in part because it rests on screening the entire population
Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men
It is critical that studies aiming to translate the development of an early-detection strategy are conducted within a diverse patient population to address prostate cancer mortality disparities
Study Design
Plan to accrue 1500 participants from both established biobanks and primary care offices
Participants will get an initial PSA screening blood test and an mpMRI
Participants will have their polygenic risk score determined from genome-wide association study GWAS data
Participant follow-up will be determined by PRS results as well as if there are abnormal findings on their PSA screening andor mpMRI
Objectives
To evaluate a screening algorithm to detect clinically relevant prostate cancer Gleason score 7 using genetic data PRS to determine risk of cancer and mpMRI to identify men with higher grade cancer
To determine optimal age to begin screening using PRS and mpMRI
To determine if rare variants in DNA repair enzymes could help refine screening
To determine if deep learning methods applied to mpMRI and informed by genetic risk can more accurately predict significant cancers
Prostate cancer screening using prostate specific antigen PSA is controversial On the one hand there is a reduction in prostate cancer mortality associated with screening On the other there is clear evidence that widespread and indiscriminate PSA based screening has led to over diagnosis and over treatment of prostate cancer In part this is due to indiscriminate screening of all men not just those at risk Development and implementation of a screening strategy specifically targeting men at risk for potentially harmful prostate cancer while sparing low risk men the burdens of screening is urgently needed
The investigators believe that integration of genetic testing and multiparametric MRI mpMRI will dramatically improve screening Polygenic risk scores PRS have been developed to determine an individuals risk of prostate cancer and attempts have been made to create risk scores for clinically relevant disease mpMRI has been established as an aid in differentiating clinically relevant from indolent prostate cancer
Our scientific premise is that an integrated approach which leverages the strengths of both genetics and mpMRI will do more than simply risk stratify men into those at risk for and not at risk for prostate cancer the investigators will stratify a population of men into those with and those without clinically relevant prostate cancer The investigators hypothesize that genetic testing to first identify patients at risk of prostate cancer followed by mpMRI to determine who likely has clinically relevant disease represents an optimal strategy
This study will determine if a polygenic risk score can be used in conjunction with mpMRI to identify Gleason score 7 cancer
Prostate cancer is the most commonly diagnosed cancer among men in the United States
Prostate cancer screening using the marker prostate-specific antigen PSA is controversial
PSA based screening is less effective at least in part because it rests on screening the entire population
Polygenic risk scores stratify men based on their prostate cancer genetic predisposition and may improve population level screening programs by focusing on men with higher risk of disease and sparing low risk men
It is critical that studies aiming to translate the development of an early-detection strategy are conducted within a diverse patient population to address prostate cancer mortality disparities
Study Design
Plan to accrue 1500 participants from both established biobanks and primary care offices
Participants will get an initial PSA screening blood test and an mpMRI
Participants will have their polygenic risk score determined from genome-wide association study GWAS data
Participant follow-up will be determined by PRS results as well as if there are abnormal findings on their PSA screening andor mpMRI
Objectives
To evaluate a screening algorithm to detect clinically relevant prostate cancer Gleason score 7 using genetic data PRS to determine risk of cancer and mpMRI to identify men with higher grade cancer
To determine optimal age to begin screening using PRS and mpMRI
To determine if rare variants in DNA repair enzymes could help refine screening
To determine if deep learning methods applied to mpMRI and informed by genetic risk can more accurately predict significant cancers
Prostate cancer screening using prostate specific antigen PSA is controversial On the one hand there is a reduction in prostate cancer mortality associated with screening On the other there is clear evidence that widespread and indiscriminate PSA based screening has led to over diagnosis and over treatment of prostate cancer In part this is due to indiscriminate screening of all men not just those at risk Development and implementation of a screening strategy specifically targeting men at risk for potentially harmful prostate cancer while sparing low risk men the burdens of screening is urgently needed
The investigators believe that integration of genetic testing and multiparametric MRI mpMRI will dramatically improve screening Polygenic risk scores PRS have been developed to determine an individuals risk of prostate cancer and attempts have been made to create risk scores for clinically relevant disease mpMRI has been established as an aid in differentiating clinically relevant from indolent prostate cancer
Our scientific premise is that an integrated approach which leverages the strengths of both genetics and mpMRI will do more than simply risk stratify men into those at risk for and not at risk for prostate cancer the investigators will stratify a population of men into those with and those without clinically relevant prostate cancer The investigators hypothesize that genetic testing to first identify patients at risk of prostate cancer followed by mpMRI to determine who likely has clinically relevant disease represents an optimal strategy
This study will determine if a polygenic risk score can be used in conjunction with mpMRI to identify Gleason score 7 cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA268810 | NIH | None | httpsreporternihgovquickSearchU01CA268810 |