The primary purpose of this study is to evaluate the influence of HSD3B1 (1245C) germline variant and potential pharmacodynamic markers on abiraterone activity in participants with metastatic castration-resistant prostate cancer after unresponsive use of diethylstilbestrol.
Study Type
OBSERVATIONAL
Enrollment
42
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.
Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes
São Paulo, Brazil
Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant'
Percentage of participants with and without HSD3B1 (1245C) germline variant will be determined to evaluate the influence of HSD3B1 (1245C) germline variant on the response to abiraterone as a predictive fact.
Time frame: Up to 12 months
Levels of HSD3B1 (1245C) Germ Variant
Levels of HSD3B1 (1245C) germline variant will be determined to evaluate the response to abiraterone acetate as a predictive factor.
Time frame: Up to 12 months
Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase
Levels of metabolite D4A during the abiraterone acetate during treatment phase will be evaluated.
Time frame: 12 Weeks
Testosterone Levels in Participants Treated with Abiraterone Acetate
Testosterone levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.
Time frame: Up to 12 months
SDHEA Levels in Participants Treated with Abiraterone Acetate
SDHEA levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.
Time frame: Up to 12 months
Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels
Correlation between HSD3B1 (1245C) variant and testosterone levels will be reported. The genotyping of the HSD3B1 (1245 A\> C) germline variant will be performed by Sanger sequencing.
Time frame: Up to 12 months
Correlation Between HSD3B1 (1245C) Variant and SDHEA Levels
Correlation between HSD3B1 (1245C) variant and SDHEA levels will be reported. The genotyping of the HSD3B1 (1245 A\> C) germline variant will be performed by Sanger sequencing.
Time frame: Up to 12 months
Correlation Between HSD3B1 (1245C) Variant and Clinical Response
Correlation between HSD3B1 (1245C) variant and clinical response will be performed by univariate and multivariate analyses.
Time frame: Up to 12 months
Correlation Between D4A Levels with Testosterone Dosage
Testosterone ultrasensitive dosages will be performed on participant serum samples. Testosterone dosage will be performed by liquid chromatography coupled with tandem mass spectrometry.
Time frame: Up to 12 months
Correlation Between D4A Levels with SDHEA Dosage
SDHEA ultrasensitive dosages will be performed on participant serum samples. Dosage will be performed by liquid chromatography coupled with tandem mass spectrometry.
Time frame: Up to 12 months
Correlation Between D4A Levels with Clinical Response
Correlation between D4A levels with clinical response will be performed by univariate and multivariate analyses.
Time frame: Up to 12 months
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