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| ID | Type | Description | Link |
|---|---|---|---|
| 212082PCR0026 | Other Identifier | Janssen-Cilag Farmaceutica Ltda. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum and plasma samples analysis | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase |
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Inclusion Criteria:
Exclusion Criteria:
- Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)
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The population of this study comprised of participants with metastatic castration-resistant prostate cancer with disease progression following the use of diethylstilbestrol (DES) who participated in the Abira-DES study (NCT02217566) in which they were treated with abiraterone acetate.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes | São Paulo | 01308901 | Brazil |
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Levels of metabolite D4A during the abiraterone acetate during treatment phase will be evaluated. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 12 months |