Urokinase Plasminogen Activator Receptor in Abiraterone Treated Patients With Castration Resistant Prostate Cancer

NCT ID: NCT02125617

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-02-14

Brief Summary

The purpose of this study is to investigate cleavage products of the urokinase plasminogenactivator receptor (uPAR) in plasma from patients with castration resistant prostate cancer as a predictive marker of response to abiraterone.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Castration-resistant prostate cancer, Progression after taxane

Treated with abiraterone 1000 mg/day Prednisolone 10 mg/day

Abiraterone

Intervention Type: DRUG

1000 mg/day

Prednisolone

Intervention Type: DRUG

10 mg/day

Interventions

Abiraterone

1000 mg/day

Intervention Type: DRUG

Prednisolone

10 mg/day

Intervention Type: DRUG

Other Intervention Names

Zytiga®

Eligibility Criteria

Inclusion Criteria

• Signed informed consent.
• Age ≥18 years and male
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Received at least one but not more than two cytotoxic chemotherapy regimens for metastatic CRPC. At least one regimen must have contained a taxane such as docetaxel.
• Prostate cancer progression as assessed by the investigator with one of the following:

• PSA progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
• Solid Tumors (RECIST) criteria or bone scans with or without PSA progression.
• Radiographic progression in soft tissue according to Response Evaluation Criteria in
• Ongoing androgen deprivation with serum testosterone <2.0 nM
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• Platelet count ≥100,000/μL
• Serum albumin ≥30 g/dL
• Serum creatinine <1.5 x upper limit of normal (ULN) or a calculated creatinine clearance ≥ 60 mL/min
• Serum potassium ≥3.5 mmol/L

Exclusion Criteria

• Received abiraterone or MDV3100 in the past.
• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
• Abnormal liver functions consisting of any of the following:

• Serum bilirubin ≥1.5 x ULN (except for subjects with documented Gilbert's disease, for whom the upper limit of serum bilirubin is 51 µmol/l)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
• Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of <50% at baseline.
• Known brain metastasis
• History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
• Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of ≤1. Chemotherapy induced alopecia and Grade 2 peripheral neuropathy is allowed.
• Use of other anticancer therapy including cytotoxic, radionucleotide, and immunotherapy; diethylstilbestrol; PC-SPES; spironolactone (ie, ALDACTONE, SPIRONOL); and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer, within 4 weeks of Cycle 1 Day 1
• Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1 Day 1
• Current enrolment in an investigational drug or device study or participation in such a study within 30 days of Day 1
• Condition or situation which, in the investigator's opinion, may put the subjects at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: collaborator

Kristoffer Rohrberg

OTHER

Sponsor Role: lead

Responsible Party

Kristoffer Rohrberg

MD, Phd

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristoffer S Rohrberg, MD, Phd

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

uPARCRPC

Identifier Type: -

Identifier Source: org_study_id