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Completed

NCT Number: NCT04268628

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

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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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes

São Paulo, 01308901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant'

    Time frame: 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 outcomes

  1. Levels of HSD3B1 (1245C) Germ Variant

    Time frame: Up to 12 months

    Levels of HSD3B1 (1245C) germline variant will be determined to evaluate the response to abiraterone acetate as a predictive factor.

  2. Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase

    Time frame: 12 Weeks

    Levels of metabolite D4A during the abiraterone acetate during treatment phase will be evaluated.

  3. Testosterone Levels in Participants Treated with Abiraterone Acetate

    Time frame: Up to 12 months

    Testosterone levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.

  4. SDHEA Levels in Participants Treated with Abiraterone Acetate

    Time frame: Up to 12 months

    SDHEA levels of participants treated with abiraterone acetate will be evaluated by the molecular analyses.

  5. Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels

    Time frame: 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.

  6. Correlation Between HSD3B1 (1245C) Variant and SDHEA Levels

    Time frame: 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.

  7. Correlation Between HSD3B1 (1245C) Variant and Clinical Response

    Time frame: Up to 12 months

    Correlation between HSD3B1 (1245C) variant and clinical response will be performed by univariate and multivariate analyses.

  8. Correlation Between D4A Levels with Testosterone Dosage

    Time frame: 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.

  9. Correlation Between D4A Levels with SDHEA Dosage

    Time frame: 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.

  10. Correlation Between D4A Levels with Clinical Response

    Time frame: Up to 12 months

    Correlation between D4A levels with clinical response will be performed by univariate and multivariate analyses.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Farmaceutica Ltda.

Industry

Registry information

Official study 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.

Acronym: EXPLORE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 13, 2020
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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