Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01350180
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2011-04-26
Brief Title:
Assessing DNA Changes in High Risk Prostate Cancer to Determine Prognosis
Sponsor:
Dr Tamim Niazi
Organization:
Sir Mortimer B Davis - Jewish General Hospital
Study Overview
Official Title:
A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
One of the biggest problems facing prostate cancer patients and their treating physicians is who needs to be treated and when Common clinical and pathological parameters are useful PSA Gleason score etc but do not clearly predict who will benefit from treatment and who will fail Genetic markers for tumor aggressivity would be of greater value The finding that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is important TMPRSS2 is controlled by androgen testosterone and ERG is part of a family of proteins which have a role in controlling cell growth cell specialization and producing tumors As a consequence of this gene fusion production of the ERG protein increases in the presence of testosterone and could be key to the development of prostate cancer resistance to treatment and poor outcome The PTEN gene is known to have a role as a tumor suppressor Its deletion is a contributing factor in the development of prostate cancers and poor outcome The coexistence of the two markers could be associated with a higher risk of recurrence
To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who despite radiation therapy and androgen suppression develop biochemical failure their PSA levels rise once again Patients participating in the PCS IV study high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached
Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital Statistical analysis will be carried out to see whether either or both markers are present whether they are associated with certain clinical and pathological high risk factors and whether they can be used to predict which patients will fail treatment
To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who despite radiation therapy and androgen suppression develop biochemical failure their PSA levels rise once again Patients participating in the PCS IV study high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached
Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital Statistical analysis will be carried out to see whether either or both markers are present whether they are associated with certain clinical and pathological high risk factors and whether they can be used to predict which patients will fail treatment
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