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

NCT04268628 | Completed

• 2 other identifiers: CR108736212082PCR0026
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Levels of HSD3B1 (1245C) Germ Variant

  Up to 12 months

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

  12 Weeks

• Testosterone Levels in Participants Treated with Abiraterone Acetate

  Up to 12 months

• SDHEA Levels in Participants Treated with Abiraterone Acetate

  Up to 12 months

• Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels

  Up to 12 months

Study Arms (1)

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).

Other: Serum and plasma samples analysis

Interventions

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.

Participants with mCRPC

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

Study Sites (1)

Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes

São Paulo, 01308901, Brazil

Location

Study Officials

• Janssen-Cilag Farmaceutica Ltda. Clinical Trial

  Janssen-Cilag Farmaceutica Ltda.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: March 19, 2020
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

BR (1)