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 (EXPLORE)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Metastatic Castration-resistant Prostate Cancer

Treatments: Other: Serum and plasma samples analysis

Study type: Observational

Funder types: Industry

Identifiers

NCT04268628

212082PCR0026 (Other Identifier)

CR108736

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)

Trial design

42 participants in 1 patient group

Participants with mCRPC

Description:

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).

Treatment:

Other: Serum and plasma samples analysis