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

NCT02125617 | Terminated DMC

• 1 other identifier: uPARCRPC
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Castration-resistant prostate cancer; Abiraterone; Biomarker; Urokinase Plasminogen Activator Receptor; Plasma; Predictive markers

Outcome Measures

Primary Outcomes (1)

• Impact of baseline uPAR cleavage products on response.

  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 Outcomes (5)

• 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).

  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).

  6 months

• Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).

  6 months

Study Arms (1)

Castration-resistant prostate cancer, Progression after taxane

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

Drug: Abiraterone; Drug: Prednisolone

Interventions

Abiraterone DRUG

1000 mg/day

Also known as: Zytiga®

Castration-resistant prostate cancer, Progression after taxane

Prednisolone DRUG

10 mg/day

Castration-resistant prostate cancer, Progression after taxane

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristoffer Rohrberg: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Abiraterone Acetate; Prednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes

Study Officials

• Kristoffer S Rohrberg, MD, Phd

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Phd

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: April 29, 2014
• Study Start: January 1, 2014
• Primary Completion: July 15, 2016
• Study Completion: February 14, 2017
• Last Updated: January 14, 2026

Record last verified: 2015-11

Locations

DK (1)