Optimizing Abiraterone Therapy (OPTIMUM)

Radboud University Medical Center

Status: Completed

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Other: Abiraterone Acetate

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02426333

UMCN AKF-14.07

Details and patient eligibility

About

The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.

Enrollment: 56 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• Age ≥18 years
• Feasible to collect blood samples from
• Life expectancy of > 6 months
• Measurable disease
• Able and willing to give written informed consent prior to screening and enrollment

Exclusion criteria

• other anticancer therapies
• potent CYP3A4 inducers
• herbal medicine that could interfere with abiraterone exposure

Trial design

56 participants in 1 patient group

Abiraterone Acetate

Description:

abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study

Treatment:

Other: Abiraterone Acetate