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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

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Official title:

Exploratory Evaluation of Genetic Polymorphism and Pharmacodynamic Parameters in Samples of Abira-DES Study Subjects (NCT02217566) - Subjects With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Following Unresponsive Treatment With Diethylstilbestrol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268628
• Other study ID #: CR108736
• Secondary ID: 212082PCR0026
• Status: Completed
• Start date: March 19, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: December 2021
• Source: Janssen-Cilag Farmaceutica Ltda.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Farmaceutica Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	12 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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