OPTIMUM: Optimizing Abiraterone Therapy

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02426333
• Collaborator: Janssen-Cilag Ltd. (Industry)
• Enrollment: 56
• Locations: 3
• Actual Duration (Months): 43
• Patients Per Site: 18.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Castration Resistant Prostate Cancer	Other: Abiraterone Acetate

Study Design

• Study Type: Observational
• Actual Enrollment: 56 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Apr 24, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Abiraterone Acetate abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study	Other: Abiraterone Acetate; Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)

Outcome Measures

Primary Outcome Measures

1. abiraterone AUC [6 months]

Secondary Outcome Measures

1. biomarkers: relation between biomarkers and treatment response [6 months]

   relation between biomarkers and treatment response

2. biomarker reduction [6 months]

   To explore the if reduction in biomarkers is related to treatment response after three and six months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeroen Bosch Ziekenhuis	Den Bosch		Netherlands
2	Canisius Wilhelmina Ziekenhuis	Nijmegen		Netherlands
3	Radboud UMC	Nijmegen		Netherlands

Sponsors and Collaborators

• Radboud University Medical Center
• Janssen-Cilag Ltd.

Investigators

• Principal Investigator: Nielka van Erp, PharmD, PhD, Radboud University Medical Center
• Principal Investigator: Jack Schalken, PhD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT02426333
• Other Study ID Numbers: UMCN AKF-14.07
• First Posted: Apr 24, 2015
• Last Update Posted: Sep 13, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Abiraterone Acetate

Study Results

No Results Posted as of Sep 13, 2019