A Study of Pharmacodynamic and Genetic Parameters of Abira-DES Study Participants (NCT02217566) - Participants With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Following Unresponsive Treatment With Diethylstilbestrol
NCT ID: NCT04268628
Last Updated: 2022-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2020-03-19
2020-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Participants with mCRPC
Participants with metastatic castration resistant prostate cancer (mCRPC) will be evaluated for genetic polymorphism and pharmacodynamic parameters from serum and plasma samples collected during the Abira-DES study (NCT02217566). Serum and plasma samples were collected after use of diethylstilbestrol (DES) and subsequent abiraterone acetate therapy. Peripheral blood samples were collected prior to initiation of abiraterone acetate therapy, after 12 weeks of therapy, and at the time of disease progression (evaluated by prostate specific antigen \[PSA\] response).
Serum and plasma samples analysis
This is a non-interventional study and no drug will be given as part of this study. Serum and plasma samples will be collected from the participants with metastatic castration-resistant prostate cancer to evaluate genetic polymorphism and pharmacodynamic parameters.
Interventions
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Serum and plasma samples analysis
This is a non-interventional study and no drug will be given as part of this study. Serum and plasma samples will be collected from the participants with metastatic castration-resistant prostate cancer to evaluate genetic polymorphism and pharmacodynamic parameters.
Eligibility Criteria
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Inclusion Criteria
* Abiraterone acetate therapy during the Abira-DES study (NCT0221756), and peripheral blood samples have been collected from at least of the three proposed study timepoints
* Must sign, and/or his/her legally acceptable representatives, where applicable, must sign the ICF allowing the use of clinical data and biological samples in accordance with local requirements. For deceased participants who did not provide consent prior to death, permission to research their information must meet local requirements
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Janssen-Cilag Farmaceutica Ltda.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Farmaceutica Ltda.
Locations
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Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes
São Paulo, , Brazil
Countries
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Other Identifiers
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212082PCR0026
Identifier Type: OTHER
Identifier Source: secondary_id
CR108736
Identifier Type: -
Identifier Source: org_study_id
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