Clinical trial · Observational
A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone
NCT01857908CI-TRIAL-00018325completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. The most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Abiraterone acetate
- description
- All patients will be receiving abiraterone acetate as per standard of care
Primary outcomes (1)
- measure
- PSA
- timeFrame
- Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression
- description
- PSA nadir samples will be assessed and compared to pre-Abiraterone treatment samples post completion of study
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent. Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. If subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel * Be suitable for receiving treatment with abiraterone acetate and prednisone * Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation * Patient consents to comply to treatment with abiraterone acetate as directed by their physician Exclusion Criteria: * Taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone * Patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism
References
Publications (0)
Data not yet available
No reference posted for this study.