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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
Sponsor:
Collaborators:
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Beijing Chao Yang Hospital
The Second Hospital of Hebei Medical University
Affiliated Hospital of Hebei University
Information provided by (Responsible Party):
Tianjin Medical University Second Hospital

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1, a biomarker for cancer stem cell), which are selected from the data of gene-array for various subtypes of CRPC (unpublished data).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.

Condition or disease
Metastatic Castration-resistant Prostate Cancer

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Abiraterone




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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
mRNA panel with AKR1C3, FKB5 and PCNA would be tested in the tissue specimen.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male only
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants having indication and planning to receiving abiraterone treatment.
Criteria

Inclusion Criteria:

  1. Participants who have given consent form;
  2. Patients with a confirmed diagnosis of mCRPC according to EAU 2017 guideline;
  3. Serum testosterone must reach castration level: <50 ng per deciliter;
  4. Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.

Exclusion Criteria:

  1. Participants who are allergic to contrast medium;
  2. Patients were excluded if they planned to receive additional concurrent anticancer therapies;
  3. Patients doesn't sign an informed consent form.

Information from the National Library of Medicine

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


Contacts
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Contact: Shimiao Zhu +8613752436539 zhushimiao@tijmu.edu.cn

Locations
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China
Tianjin Medical Unversity Second Hospital Recruiting
Tianjin, China, 300211
Contact: Rong Han    +86 022 8832 8677    miyansuo@126.com   
Principal Investigator: Yuanjie Niu, MD,PhD         
Sub-Investigator: Shimiao Zhu, MD,PhD         
Sponsors and Collaborators
Tianjin Medical University Second Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Beijing Chao Yang Hospital
The Second Hospital of Hebei Medical University
Affiliated Hospital of Hebei University
Investigators
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Principal Investigator: Rong Han Tianjin Medical University Second Hospital
Publications:

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Responsible Party: Tianjin Medical University Second Hospital
ClinicalTrials.gov Identifier: NCT03176381    
Other Study ID Numbers: mCRPC-PA
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD can be got by contacting researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tianjin Medical University Second Hospital:
Prostatic Neoplasms
Abiraterone Acetate
FK506 binding protein 5
Neurotensin
yes-associated protein 1
AKR1C3 protein
Proliferating Cell Nuclear Antigen
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases