Condition category
Cancer
Date applied
23/01/2012
Date assigned
06/02/2012
Last edited
02/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
Prostate cancer is the most common type of tumour and the second leading cause of all cancer-related deaths in men. Prostate cancer in advanced stages develops metastasis- most often in bones. In the clinical course, the cancer is very often resistant to hormone therapy (androgen resistance), which is associated with a poor outcome. For 20 - 40% of patients, those with advanced disease at the time of diagnosis there is currently no effective treatment. Basis in the current diagnosis of prostate cancer are digital rectal examination (DRE), the determination of prostate specific antigen (PSA) levels, transrectal ultrasonography (TRUS) and prostate biopsy. PSA is currently the most specific tumour marker for diagnosis, screening and monitoring of prostate cancer. PSA is not a disease-specific marker, since it is also increased in a condition called benign prostate hyperplasia (BPH) and in infected/inflamed prostate glands, conditions which are rather common (they can occur in 25-86% of prostate cancer patients). Also PSA levels may be raised in other non-cancerous diseases, and may even be raised in healthy individuals and there is also the possibility that prostate cancer may be missed in a significant number of patients. The limitations of the PSA assay reflect the lack of reliable measures for predicting the transition from local to metastatic cancer stages. New methods are needed to help doctors in their diagnosis.
The GILUPI GmbH developed a medical device for the isolation of circulating tumour cells (CTCs) directly from the bloodstream. This method has the advantage of capturing the limited number of CTCs directly, instead of using a small blood sample. A thin medical wire, also called nanodetector, is inserted through a conventional venous cannula routinely placed in a vein in the elbow area, so that about 2 cm of the wire reach into the bloodstream. The nanodetector has a special coating which has the ability to bind cancer cells, which after removal of the wire can be counted under the microscope, thus estimating the number of circulating tumour cells in the patient’s blood. This in vivo method has the advantage of “fishing” for tumour cells in a much larger volume instead of using only a small blood sample from the patient. Using the fishing analogy, a blood draw would resemble a person going to a river with a bucket and hoping to have a fish in a bucket full of water, whilst the nanodetector resembles a fishing rod placed into the river.
With this study we want to evaluate the sensitivity and specificity of the nanodetector regarding the isolation of EpCAM-positive tumour cells in prostate cancer patients compared to benign prostate disease and healthy individuals. Secondary objectives are to compare the nanodetector method with the reference system CellSearch, and to see if the isolated tumour cells can be used for the analysis of certain cancer related proteins.

Who can participate?
Requirements to participate in the study:
Group A: prostate cancer patients, confirmed diagnosis of prostate cancer of any stage
Group B: BPH control group, Confirmed diagnosis of any stage of BPH
Group C: Healthy control subjects, female

What does the study involve?
If you take part in the study, first of all, you will be asked to give a small sample of blood to test blood values for inclusion and exclusion criteria. Should you be eligible to participate, the nanodetector will be inserted in an elbow vein. The procedure of the insertion of the nanodetector is similar to inserting a small tube for blood collection and takes 30 min. This is a standard procedure in hospitals and medical practices. All patients in the study are treated in the same way. Afterwards you will be asked again to give a small sample of blood to check if blood values change after the insertion of the nanodetector, and to have a sample for the control method Cell Search.
If you are in group A with prostate cancer and with metastases, you will have 8 applications with the nanodetector (every month in for the first six months, 7th application in the 9th month, 8th application in the 12th month). If you are in group A with prostate cancer without metastases, you will have 3 applications (before surgery, 6 months after surgery and one year after operation). If you are in group B (BPH) you will have 3 applications (1st month, 6th month, 12th month). If you belong to group C (healthy subjects) you will have one application.

What are the possible benefits and risks of participating?
The cancer patients participating benefit from increased regular medical care, ranging from the provision of additional, non-routine measurement of certain blood parameters (cytokines, and the results of clinical examination (results of downstream diagnostics: ability to distinguish between a localized and metastatic prostate cancer).
The application with the nanodetector is similar to a normal blood collection. Therefore the risk for the participants is comparable to the risk of a normal blood collection. All insertions of the nanodetector will be carried out by trained physicians.

Where is the study taking place?
The study takes place at the university hospital and health care centre of Urology and Kidney transplantation centre of the Martin-Luther University Halle-Wittenberg, Germany.

When is the study starting and how long is it expected to run for?
Patients have been enrolled since December 2010, and the study will end 1 year after inclusion of the last cancer or BPH patient. By that time 105 patients should have been enrolled.

Who is funding the study?
The study is being funded by the GILUPI company (Potsdam, Germany)

Who is the main contact?
Kathrin Haubold (Trial Manager)
kathrin.haubold@gilupi.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andre Schumann

ORCID ID

Contact details

Klinik und Poliklinik für Urologie und Nierentransplantationszentrum der Universität Halle-Wittenberg
Ernst-Grube-Strasse 40
Halle
06120
Germany
+49 345 5571 674
andre.schumann@uk-halle.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CIP FSMW EpCAM-Prostata-M000

Study information

Scientific title

Isolation of circulating tumor cells from the blood of prostate cancer patients using an antibody-coated nanodetector: An explorative mono-center non-randomized blinded trial

Acronym

Study hypothesis

This is a single-center exploratory study in which an antibody coated nanodetector called the Functionalized Structured Medical Wire (FSMW) is evaluated in vivo as a medical device. The performance of the FSMW will be estimated by counting the number of circulating tumor cells isolated in vivo. The specificity is determined by a single application in healthy subjects.

The CellSearch system, using a similar antibody-based extraction technique for circulating tumor cells in a single blood sample in vitro, will be used as a reference system. Furthermore the CEER-Assay (Prometheus Labs) will be used for an explorative analysis of certain tumor relevant protein pathways on the isolated circulating tumor cells (CTCs).

Please note that as of 02/11/2012, the following changes were made to the record:
1. The target number of participants was updated from 80 to 105
2. The anticipated end date was updated from 28/02/2013 to 31/03/2014

Ethics approval

The Committee on Ethics at the Medical Faculty of the Martin-Luther University in Halle,13th April 2010 (ref: FSMW EpCAM-Prostata-M000); amendment 1 approved on 16th June 2011, amendment 2 on 24th July 2011 , amendment 3 on 20th April 2012 and amendment 4 on 20th July 2012.

Study design

Explorative mono-center non-randomised blinded trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Prostate cancer (all stages), Benign prostatic hyperplasia (all stages)

Intervention

The nanodetector will be inserted in all patients from all groups (A, B and C) for 30 min. With this study we want to compare different methods to detect CTCs. Within the groups there are different sets of downstreaming diagnostics.
Group A: 50 % of all patients from this group the nanodetector will be analysed with immunocytochemistry. From the same patients a blood sample will be taken and analysed with the CellSearch method. From 50 % the nanodetector will be analysed with the CEER-Assay.
Group B: : 75 % of all patients from this group the nanodetector will be analysed with immunocytochemistry. From 50 % of the patients a blood sample will be taken and analysed with the CellSearch method. From 25 % the nanodetector will be analysed with the CEER-Assay.
Group C: 75 % of all patients from this group the nanodetector will be analysed with immunocytochemistry. From 25 % of the patients a blood sample will be taken and analysed with the CellSearch method. From 25 % the nanodetector will be analysed with the CEER-Assay.

All methods for detecting circulating tumor cells will be compared at the end of the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Positive isolation of circulating tumor cells from peripheral blood of patients with prostate cancer by using the nanodetector (proof of concept) in comparision to patiens with BPH and healthy volonteers
2. Investigation of the specificity of the device

Secondary outcome measures

1. Review of product-application-procedures
2. Comparison of the results with the CellSearch® method
3. Explorative analysis of cancer related cell pathway proteins by using the CEER-Assay (Prometheus Labs)

Overall trial start date

01/12/2010

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Group A
1. Confirmed diagnosis of prostate cancer of any stage
2. Written informed consent of the patient after explanation by the investigator

Group B
1. Are patients which must have the diagnosis of any stages of Benign prostatic hyperplasia (BPH). But apart from this diagnosis, the patients are healthy.
2. Written informed consent of the patient after explanation by the investigator

Group C:
1. Healthy female probands according to anamnestic and clinical criteria
2. Written informed consent of the patient after explanation by the investigator

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

105

Participant exclusion criteria

For all groups
1. Age > 18 years
2. Known anaphylaxis
3. Auto immunological diseases: Anti-phospholipid antibody syndrome (lupus anticoagulant), Goodpasture's syndrome, lupus erythematosus, relapsing polychondritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, antineutrophilic cytoplasmic antibody (ANCA); Immuno deficiencies: X-linked aggamaglobulinaemia (XLA), severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), selective IgA deficiency
3. Known infection with: Hepatitis A, B and C, human immunodeficiency virus (HIV), herpes simplex virus (HSV), cytomegalovirus (CMV), syphilis, toxoplasmosis, tuberculosis
4. Not allowed concomitant medication: oral anticoagulants (Phenprocoumon, Coumadin), Platelet aggregation inhibitors (clopidogrel, prasugrel, ASS); recurrent thrombosis and pulmonary embolism
In addition for:
Group A: heart rhythm disturbances, clinically significant hypotension or hypovolemia
Group B:diagnosis prostate cancer
Group C: pregnancy and lactation, malignant tumour

Recruitment start date

01/12/2010

Recruitment end date

31/03/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Klinik und Poliklinik für Urologie und Nierentransplantationszentrum der Universität Halle-Wittenberg
Halle
06120
Germany

Sponsor information

Organisation

GILUPI GmbH (Germany)

Sponsor details

Am Mühlenberg 11
Potsdam
14476
Germany
+49 331 5818 478 6
Kathrin.haubold@gilupi.com

Sponsor type

Industry

Website

http://www.gilupi.com

Funders

Funder type

Industry

Funder name

GILUPI GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes