Ignite Creation Date:
2024-05-06 @ 10:07 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03176381
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2017-06-01
Brief Title:
Tissue Predictors of Abiraterone Benefit
Sponsor:
Tianjin Medical University Second Hospital
Organization:
Tianjin Medical University Second Hospital
Study Overview
Official Title:
Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This is an observational prospective study following participants forward in time multi-center study conducted in more than 1 center study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer mCRPC The entire duration of study will be approximately 3 year Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria For this we put our attentions on the HOXB3 an alternative factor of WNT signaling pathway FKBP5 FK506 Binding Protein 5 Androgen-regulated gene NTS neurotensin neuroendocrine differentiation can be induced by NTS and YAP1 yes-associated protein 1 a biomarker for cancer stem cell which are selected from the data of gene-array for various subtypes of CRPC unpublished data Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA
Detailed Description:
It is now accepted that castration-resistant prostate cancer CRPC is not really androgen-independent and continues to rely on androgen signaling Abiraterone is an inhibitor of cytochrome P450 17A1 CYP17A1 that impairs androgen-receptor signaling by depleting adrenal and intratumoral androgens After studies showed improved survival with abiraterone it was approved by the Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer mCRPC
mCRPC is a syndrome other than a disease The mechanisms of mCRPC contain aberrant activation of androgen signaling abnormal transition between epithelial and mesenchymal and induction of neuroendocrine differentiation NED In addition cellular heterogeneity represents an omnipresent feature in human tumors which contain cells with diverse morphology cytogenetic markers growth kinetics immunological characteristics metastatic ability and sensitivity to therapeutics
This is an observational prospective study following participants forward in time multi-center study conducted in more than 1 center study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer mCRPC The entire duration of study will be approximately 3 year Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria For this we put our attentions on the FKBP5 FK506 Binding Protein 5 Androgen-regulated gene NTS neurotensin neuroendocrine differentiation can be induced by NTS and YAP1 yes-associated protein 1 a biomarker for cancer stem cell which are selected from the data of gene-array for various subtypes of CRPC Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA
mCRPC is a syndrome other than a disease The mechanisms of mCRPC contain aberrant activation of androgen signaling abnormal transition between epithelial and mesenchymal and induction of neuroendocrine differentiation NED In addition cellular heterogeneity represents an omnipresent feature in human tumors which contain cells with diverse morphology cytogenetic markers growth kinetics immunological characteristics metastatic ability and sensitivity to therapeutics
This is an observational prospective study following participants forward in time multi-center study conducted in more than 1 center study to identify the predictive factors that will effectively predict the response to abiraterone treatment in metastatic castration-resistant prostate cancer mCRPC The entire duration of study will be approximately 3 year Participants will primarily be evaluated for achieving biochemical or radiological progression after receiving abiraterone treatment based on EAU 2017 practice guideline criteria For this we put our attentions on the FKBP5 FK506 Binding Protein 5 Androgen-regulated gene NTS neurotensin neuroendocrine differentiation can be induced by NTS and YAP1 yes-associated protein 1 a biomarker for cancer stem cell which are selected from the data of gene-array for various subtypes of CRPC Response to abiraterone treatment will also be predicted using other androgen-regulated genes like AKR1C3 and PCNA
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?:
True
Is an FDA AA801 Violation?:
None