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
- Conditions
- Metastatic Castration-resistant Prostate Cancer
- Interventions
- Other: Serum and plasma samples analysis
- Registration Number
- NCT04268628
- Lead Sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
- Must have a confirmed diagnosis of prostate adenocarcinoma without neuroendocrine or small cell differentiation and was a participant in the Abira-DES study (NCT0221756), which includes: diethylstilbestrol pretreatment for castration-resistant prostate cancer with evidence of disease progression or grade 3/4 toxicity with diethylstilbestrol; metastatic disease confirmed by bone examination or metastatic lesions by computed tomography or magnetic resonance
- 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
- Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with mCRPC Serum and plasma samples analysis 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant' Up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase 12 Weeks Levels of metabolite D4A during the abiraterone acetate during treatment phase will be evaluated.
Correlation Between D4A Levels with Clinical Response Up to 12 months Correlation between D4A levels with clinical response will be performed by univariate and multivariate analyses.
Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels Up to 12 months 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.
Correlation Between D4A Levels with Testosterone Dosage Up to 12 months Testosterone ultrasensitive dosages will be performed on participant serum samples. Testosterone dosage will be performed by liquid chromatography coupled with tandem mass spectrometry.
Testosterone Levels in Participants Treated with Abiraterone Acetate Up to 12 months Testosterone levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.
Correlation Between HSD3B1 (1245C) Variant and Clinical Response Up to 12 months Correlation between HSD3B1 (1245C) variant and clinical response will be performed by univariate and multivariate analyses.
Correlation Between D4A Levels with SDHEA Dosage Up to 12 months SDHEA ultrasensitive dosages will be performed on participant serum samples. Dosage will be performed by liquid chromatography coupled with tandem mass spectrometry.
Levels of HSD3B1 (1245C) Germ Variant Up to 12 months Levels of HSD3B1 (1245C) germline variant will be determined to evaluate the response to abiraterone acetate as a predictive factor.
Correlation Between HSD3B1 (1245C) Variant and SDHEA Levels Up to 12 months 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.
SDHEA Levels in Participants Treated with Abiraterone Acetate Up to 12 months SDHEA levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.
Trial Locations
- Locations (1)
Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes
🇧🇷São Paulo, Brazil