Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706663
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-01-12
Brief Title:
Precision-Based Genomics in Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multi-Center Natural History Study of Precision-Based Genomics in Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09-26
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:
None
Brief Summary:
Background
Prostate cancer is the most common cancer and the second leading cause of death in males in the United States Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is
Objective
To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment
Eligibility
Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study andor have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time
Design
Participants will be screened with a review of their medical records Their gene test results will be reviewed if available They will be asked questions over the phone or in person
Participants do not need to visit the NIH for this study But if they visit NIH for another study their data and test results will be collected They may give blood and urine samples They may give leftover tumor samples These samples will be used to study their genes
Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail They will be asked questions about their health Data from their medical records will be collected
Participants will have testosterone and prostate-specific antigen PSA tests
Participants may be invited to NIH to give blood samples for research
Participants on this study will be followed for life
Prostate cancer is the most common cancer and the second leading cause of death in males in the United States Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is
Objective
To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment
Eligibility
Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study andor have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time
Design
Participants will be screened with a review of their medical records Their gene test results will be reviewed if available They will be asked questions over the phone or in person
Participants do not need to visit the NIH for this study But if they visit NIH for another study their data and test results will be collected They may give blood and urine samples They may give leftover tumor samples These samples will be used to study their genes
Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail They will be asked questions about their health Data from their medical records will be collected
Participants will have testosterone and prostate-specific antigen PSA tests
Participants may be invited to NIH to give blood samples for research
Participants on this study will be followed for life
Detailed Description:
Background
Prostate cancer is the most common cancer and the second leading cause of death in males in the United States with an estimated 191930 new cases and 33330 deaths in 2020
There has been progress in identifying established risk factors for the development of prostate cancer including genetic predisposition The study of the molecular genetics of prostate cancer has identified pathogenic variants such as BRCA1 and BRCA2 associated with hereditary breast and ovarian cancer syndrome HOXB13 associated with hereditary prostate cancer and DNA mismatch repair MMR gene variants MLH1 MSH2 MSH6 PMS2 and EPCAM associated with Lynch syndrome
While our understanding of molecular genetics continues to grow there remains a need to identify additional germline and somatic mutations and alterations that may increase an individual s risk to develop prostate cancer and potentially the aggressiveness of the disease In studying the following alterations in prostate cancer in both localized and advanced stages potential expanded molecular findings may lead to actionable therapeutic targets and biomarker development A better understanding of molecular genetics in a longitudinal study of subjects with prostate cancer may be helpful for the design of future treatment studies and to develop a better understanding of the natural history of the disease
Objectives
To longitudinally evaluate subjects with prostate cancer with known germline andor somatic variants in PIK3 andor AKT PALB2 BRIP1 RAD50 RAD51 RAD54 RB1 SPOP WntB-catenin pathway CDK12 and MMR genes MLH1 MSH2 MSH6 PMS2 and EPCAM to better understand the natural history of the disease
To longitudinally evaluate subjects with tumor mutational burden-high TMB-H prostate cancer greater than or equal to 10 mutationsmegabase mutMb or blood TMB bTMB greater than or equal to16 mutMb
Eligibility
Subjects with histologically confirmed prostate cancer
Must have known germline andor somatic variants in PIK3 andor AKT PALB2 BRIP1 RAD50 RAD51 RAD54 RB1 SPOP WntB-catenin pathway CDK12 and MMR genes MLH1 MSH2 MSH6 PMS2 and EPCAM andor TMB-high or be deemed an exceptional responder NOTE any platform for genomics testing is acceptable research or CLIA-certified
Age greater than or equal to 18 years old
Design
This will be a long-term multi-center study to comprehensively study participants with prostate cancer
Participants will provide clinical information including medical history clinical tests imaging studies and reports surgical pathology reports genetic test results
Since long-term follow-up of individuals with prostate cancer is a major feature of the study local sites intend to maintain active contact with study subjects for as long as possible Participants will be followed throughout the course of their illnesses with particular attention to patterns of disease recurrence and progression response to therapies and duration of responses
Prostate cancer is the most common cancer and the second leading cause of death in males in the United States with an estimated 191930 new cases and 33330 deaths in 2020
There has been progress in identifying established risk factors for the development of prostate cancer including genetic predisposition The study of the molecular genetics of prostate cancer has identified pathogenic variants such as BRCA1 and BRCA2 associated with hereditary breast and ovarian cancer syndrome HOXB13 associated with hereditary prostate cancer and DNA mismatch repair MMR gene variants MLH1 MSH2 MSH6 PMS2 and EPCAM associated with Lynch syndrome
While our understanding of molecular genetics continues to grow there remains a need to identify additional germline and somatic mutations and alterations that may increase an individual s risk to develop prostate cancer and potentially the aggressiveness of the disease In studying the following alterations in prostate cancer in both localized and advanced stages potential expanded molecular findings may lead to actionable therapeutic targets and biomarker development A better understanding of molecular genetics in a longitudinal study of subjects with prostate cancer may be helpful for the design of future treatment studies and to develop a better understanding of the natural history of the disease
Objectives
To longitudinally evaluate subjects with prostate cancer with known germline andor somatic variants in PIK3 andor AKT PALB2 BRIP1 RAD50 RAD51 RAD54 RB1 SPOP WntB-catenin pathway CDK12 and MMR genes MLH1 MSH2 MSH6 PMS2 and EPCAM to better understand the natural history of the disease
To longitudinally evaluate subjects with tumor mutational burden-high TMB-H prostate cancer greater than or equal to 10 mutationsmegabase mutMb or blood TMB bTMB greater than or equal to16 mutMb
Eligibility
Subjects with histologically confirmed prostate cancer
Must have known germline andor somatic variants in PIK3 andor AKT PALB2 BRIP1 RAD50 RAD51 RAD54 RB1 SPOP WntB-catenin pathway CDK12 and MMR genes MLH1 MSH2 MSH6 PMS2 and EPCAM andor TMB-high or be deemed an exceptional responder NOTE any platform for genomics testing is acceptable research or CLIA-certified
Age greater than or equal to 18 years old
Design
This will be a long-term multi-center study to comprehensively study participants with prostate cancer
Participants will provide clinical information including medical history clinical tests imaging studies and reports surgical pathology reports genetic test results
Since long-term follow-up of individuals with prostate cancer is a major feature of the study local sites intend to maintain active contact with study subjects for as long as possible Participants will be followed throughout the course of their illnesses with particular attention to patterns of disease recurrence and progression response to therapies and duration of responses
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 |
|---|---|---|---|
| 000048-C | None | None | None |