Prostatic NeoplasmsuPARCRPCNCT02125617
Urokinase Plasminogen Activator Receptor in Abiraterone Treated Patients With Castration Resistant Prostate Cancer
An observational study of Prostatic Neoplasms, run by Kristoffer Rohrberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Abiraterone and Prednisolone
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to 14 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, 2100
About this study
Official title: 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- Abiraterone, Prednisolone
- Keywords
- Castration-resistant prostate cancer, Abiraterone, Biomarker, Urokinase Plasminogen Activator Receptor, Plasma, Predictive markers
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Also called Zytiga®
1000 mg/day
PrednisoloneDrug
10 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Castration-resistant prostate cancer, Progression after taxane | Treated with abiraterone 1000 mg/day Prednisolone 10 mg/day Receives: Drug: Abiraterone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
Impact of baseline plasma concentration of uPAR cleavage products on overall survival (OS).
Impact of baseline plasma concentration of uPAR cleavage products on overall survival (OS).
Measured: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on progression free survival (PFS).
Impact of baseline plasma concentration of uPAR cleavage products on progression free survival (PFS).
Measured: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on pain relief rate.
Impact of baseline plasma concentration of uPAR cleavage products on pain relief rate.
Measured: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on disease control rate (DCR).
Impact of baseline plasma concentration of uPAR cleavage products on disease control rate (DCR).
Measured: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).
Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion15 Jul 2016
- Study completion14 Feb 2017
Why it stopped: Poor recruition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristoffer Rohrberg
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor-investigator, Kristoffer Rohrberg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kristoffer S Rohrberg, MD, Phd, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125617
- Sponsor's protocol ID
- uPARCRPC
- Acronym
- uPARCRPC
- Status last verified
- Nov 2015
- First submitted
- 25 Apr 2014
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- uPAR in Blood From Zytiga® (Abiraterone) Treated Patients With Castration Resistant Prostate Cancer - a Predictive Marker of Response?
- ClinicalTrials.gov ID
- NCT02125617
- Acronym / sponsor ID
- uPARCRPC / uPARCRPC
- Conditions
- Prostatic Neoplasms
- Keywords
- Castration-resistant prostate cancer, Abiraterone, Biomarker, Urokinase Plasminogen Activator Receptor, Plasma, Predictive markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruition
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Kristoffer RohrbergUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Jan 2014
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Castration-resistant prostate cancer, Progression after taxane | – | Drug: Abiraterone, Drug: PrednisoloneTreated with abiraterone 1000 mg/day Prednisolone 10 mg/day |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (16 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbirateroneAlso: Zytiga®1000 mg/day | Drug | Castration-resistant prostate cancer, Progression after taxane |
| Prednisolone10 mg/day | Drug | Castration-resistant prostate cancer, Progression after taxane |
Primary outcome
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.
5 secondary outcomes
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 progression free survival (PFS).
Time frame: 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 disease control rate (DCR).
Time frame: 6 months
Impact of baseline plasma concentration of uPAR cleavage products on serious adverse events (SAE).
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Poor recruition). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristoffer S Rohrberg, MD, Phd study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Kristoffer Rohrberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruition). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of baseline uPAR cleavage products on response. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.