Tissue Predictors of Abiraterone Benefit
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|ClinicalTrials.gov Identifier: NCT03176381|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : June 2, 2022
|Condition or disease|
|Metastatic Castration-resistant Prostate Cancer|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Development of Tissue Predictors of Abiraterone Benefit in Men With mCRPC|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2023|
- PSA response rates [ Time Frame: 2 YEARS ]PSA response rates between FKBP5(protein)-positive and FKBP5(protein)-negative (including YAP1-positive and NTS-positive) patients; PSA response rates between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
- PSA progression-free survival (pPFS) [ Time Frame: 3 YEARS ]pPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; pPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
- clinical or radiographic progression-free survival (cPFS) [ Time Frame: 3 YEARS ]cPFS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; cPFS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
- overall survival (OS) [ Time Frame: 3 YEARS ]OS between FKBP5-positive and FKBP5-negative (including YAP1-positive and NTS-positive) patients; OS between patients with higher or lower expression of androgen-regulated genes (AKR1C3, FKB5, PCNA).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176381
|Contact: Shimiao Zhufirstname.lastname@example.org|
|Tianjin Medical Unversity Second Hospital||Recruiting|
|Tianjin, China, 300211|
|Contact: Rong Han +86 022 8832 8677 email@example.com|
|Principal Investigator: Yuanjie Niu, MD,PhD|
|Sub-Investigator: Shimiao Zhu, MD,PhD|
|Principal Investigator:||Rong Han||Tianjin Medical University Second Hospital|