Measurement of Circulating Tumor Cells in Prostate Cancer

NCT ID: NCT04101305

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-12-31

Brief 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?

Detailed 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.

Conditions

Prostatic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Localised prostate cancer

Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation

IsoPic

Intervention Type: DIAGNOSTIC_TEST

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Stage 3 prostate cancer

Patients with diagnosed stage 3 prostate cancer

IsoPic

Intervention Type: DIAGNOSTIC_TEST

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Stage 4 prostate cancer

Patients with diagnosed stage 4 prostate cancer

IsoPic

Intervention Type: DIAGNOSTIC_TEST

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Healthy controls

Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition

IsoPic

Intervention Type: DIAGNOSTIC_TEST

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Interventions

IsoPic

Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 125 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

iCellate Medical

INDUSTRY

Sponsor Role: collaborator

Sormland County Council, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Christer Ericsson

Senior scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evangelos Digkas, MD, PhD

Role: STUDY_DIRECTOR

Region Sormland

Locations

Malarsjukhuset

Eskilstuna, Sormland, Sweden

Countries

Sweden

Central Contacts

Ninos Oussi, MD

Role: CONTACT

ninos.oussi@ki.se

+4616103000

Evangelos Digkas, MD, PhD

Role: CONTACT

Evangelos.Digkas@regionsormland.se

+46728598648

Facility Contacts

Evangelos Digkas, MD, PhD

Role: primary

Evangelos.Digkas@regionsormland.se

+46728598648

Ninos Oussi, MD

Role: backup

ninos.oussi@ki.se

+46016103000

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

2019-02592

Identifier Type: -

Identifier Source: org_study_id