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

January 12, 2026 updated by: Kristoffer Rohrberg

uPAR in Blood From Zytiga® (Abiraterone) Treated Patients With Castration Resistant Prostate Cancer - a Predictive Marker of Response?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • University Hospital of Copenhagen, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for this study include patients with CRPC in progression after therapy with a taxane who are candidates for therapy with standard second line therapy abiraterone.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Castration-resistant prostate cancer, Progression after taxane
Treated with abiraterone 1000 mg/day Prednisolone 10 mg/day
Drug: Abiraterone
1000 mg/day
Other Names:
  • Zytiga®
Drug: Prednisolone
10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of baseline uPAR cleavage products on response.
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on overall response rate (ORR) defined as the proportion of patients with radiologic response according to the RECIST criteria or PSA-response.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of baseline plasma concentration of uPAR cleavage products on overall survival (OS).
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on overall survival (OS).
6 months
Impact of baseline plasma concentration of uPAR cleavage products on progression free survival (PFS).
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on progression free survival (PFS).
6 months
Impact of baseline plasma concentration of uPAR cleavage products on pain relief rate.
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on pain relief rate.
6 months
Impact of baseline plasma concentration of uPAR cleavage products on disease control rate (DCR).
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on disease control rate (DCR).
6 months
Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).
Time Frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristoffer Rohrberg

Collaborators

Janssen-Cilag Ltd.

Investigators

  • Study Chair: Kristoffer S Rohrberg, MD, Phd, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 15, 2016

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimated)

April 29, 2014

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uPARCRPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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