Measurement of Circulating Tumor Cells in Prostate Cancer

Prostatic Neoplasms Clinical Trial

— ICELLATEPC  

Official title:

Measurement of Circulating Tumor Cells in Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04101305
• Other study ID #: 2019-02592
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: December 2021

Study information

• Verified date: September 2019
• Source: Sormland County Council, Sweden
• Contact: Ninos Oussi, MD
• Phone: +4616103000
• Email: ninos.oussi[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients? Is it possible to understand the causal relationship between the occurrence of the tumor cells and the tumor DNA in the blood by reviewing the patient's medical records, including information about investigations, analytical reports or diagnoses? Can gene defects that may be useful in predicting the best treatment be detected by sequencing individual tumor cells or plasma from blood samples?

Description:

Prostate cancer is the most common form of cancer in men and the second most deadly. Today's diagnostic methods and treatments are therefore obviously not adequate. In this study we will evaluate a new diagnostic sampling and analysis method for prostate cancer, not try new treatments. The test sampling involves the rare tumor cells and tumor DNA found in the blood, and sequencing their DNA to determine which, if any, defective genes they contain that may explain the disease. There is currently no universally accepted diagnostic test of either tumor cells or tumor DNA in blood. We have access to new technology that one of us (CE) developed at the Karolinska Institute, which by all accounts can give access to the rare tumor cells in the blood so that we can sequence their DNA. In this study we want to try to see if it is possible in practical healthcare to apply the new technology for prostate cancer patients and if there are signs that it works equally well in the healthcare environment as in the laboratory.

Impact: If the sampling of tumor cells and tumor DNA from blood samples works within the healthcare system processes, it will be possible to understand the causal relationships behind their occurrence, and their gene defects, we can design follow-up studies that would take us closer to clinical use of the new technology to predict which treatment would be most effective and which treatment would produce the least side effects.

Ethical considerations: The risks of blood sampling are limited and known and can be managed within the healthcare system. Data is handled safely. The potential future benefit of a new cancer cell- and DNA-test is great.

The study is a collaboration between Region Sörmland, Karolinska Institutet and iCellate Medical AB. The data collection is expected to be completed in 2020 and the analyses in 2021.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 125 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with prostate cancer of moderate risk planned for prostatectomy with lymph node removal, or

• patients diagnosed with prostate cancer stage 3, or

• patients with diagnosed prostate cancer stage 4, or

• patients with diagnosed benign inflammatory prostatitis or other benign urological condition constituting age-matched, cancer free, controls

Exclusion Criteria:

• Patients undergoing prostate cancer treatment (no prostate cancer treatment should be given to the patient before blood collection)

• Patients with previous malignancy

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• IsoPic
Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Locations

Country	Name	City	State
Sweden	Malarsjukhuset	Eskilstuna	Sormland

Sponsors (3)

Lead Sponsor	Collaborator
Sormland County Council, Sweden	iCellate Medical, Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Castro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109

Castro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212

Castro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single cell DNA sampling	Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?	September 2019 to December 31st, 2020
Secondary	Comparison of novel sampling results to established biomarkers	Is it possible to understand the causal link between the presence and amounts of tumor cells and tumor DNA in the blood by reviewing the patient's medical records, including information on investigations, analysis reports and diagnosis?	September 2019 to December 31st, 2020
Secondary	Single cell DNA sequencing	Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?	September 2019 to December 31st, 2020

External Links

•   Government agency supervised clinical tumor cell and tumor DNA testing laboratory
•   Malarsjukhuset hospital service information, in the Swedish language