Clinical trial 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
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant'
timeFrame: Up to 12 months
Secondary outcomes:
measure: Levels of HSD3B1 (1245C) Germ Variant
timeFrame: Up to 12 months
measure: Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase
timeFrame: 12 Weeks
measure: Testosterone Levels in Participants Treated with Abiraterone Acetate
timeFrame: Up to 12 months
measure: SDHEA Levels in Participants Treated with Abiraterone Acetate
timeFrame: Up to 12 months
measure: Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels
timeFrame: Up to 12 months
measure: Correlation Between HSD3B1 (1245C) Variant and SDHEA Levels
timeFrame: Up to 12 months
measure: Correlation Between HSD3B1 (1245C) Variant and Clinical Response
timeFrame: Up to 12 months
measure: Correlation Between D4A Levels with Testosterone Dosage
timeFrame: Up to 12 months
measure: Correlation Between D4A Levels with SDHEA Dosage
timeFrame: Up to 12 months
measure: Correlation Between D4A Levels with Clinical Response
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References: