Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02573636
Status:
RECRUITING
Last Update Posted:
2020-10-20
First Post:
2015-10-05
Brief Title:
The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy
Sponsor:
Sir Mortimer B Davis - Jewish General Hospital
Organization:
Sir Mortimer B Davis - Jewish General Hospital
Study Overview
Official Title:
The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients With Biochemical Failure Status Post Salvage or Radical Radiation Therapy
Status:
RECRUITING
Status Verified Date:
2020-10
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:
None
Brief Summary:
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure
Detailed Description:
The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure
Patients in this study will be treated with standard hormonal treatment Patients will remain on treatment regardless of rising PSA PSA other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy this would be at the discretion of the treating oncologist
The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together and to determine the association of these markers with overall survival
Patients in this study will be treated with standard hormonal treatment Patients will remain on treatment regardless of rising PSA PSA other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy this would be at the discretion of the treating oncologist
The primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together and to determine the association of these markers with overall survival
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