Metastatic Castration Resistant Prostate Cancer Clinical Trial
— OPTIMUMOfficial title:
Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker ‐ Drug Exposure ‐ as a Predictor for Drug Response in Patients With mCRPC
| NCT number | NCT02426333 |
| Other study ID # | UMCN AKF-14.07 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | August 1, 2019 |
| Verified date | September 2019 |
| Source | Radboud University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | August 1, 2019 |
| Est. primary completion date | April 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
| Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
| Netherlands | Radboud UMC | Nijmegen |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University | Janssen-Cilag Ltd. |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | abiraterone AUC | 6 months | ||
| Secondary | biomarkers: relation between biomarkers and treatment response | relation between biomarkers and treatment response | 6 months | |
| Secondary | biomarker reduction | To explore the if reduction in biomarkers is related to treatment response after three and six months | 6 months |
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