Measurement of Circulating Tumor Cells in Prostate Cancer

• Conditions: Prostatic Neoplasms
• Interventions: Diagnostic Test: IsoPic

• Registration Number: NCT04101305
• Lead Sponsor: Sormland County Council, Sweden

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.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Study First Posted: 2019-09-24
• Last Update Posted: 2019-09-24
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 3 prostate cancer	IsoPic	Patients with diagnosed stage 3 prostate cancer
Stage 4 prostate cancer	IsoPic	Patients with diagnosed stage 4 prostate cancer
Localised prostate cancer	IsoPic	Patients diagnosed with prostate cancer of moderate estimated risk suitable for and scheduled for prostatectomy with gland evacuation
Healthy controls	IsoPic	Age-matched healthy individuals free from diagnosed cancer, but with benign inflammatory prostatitis or other benign urological condition

Primary Outcome Measures

Name	Time	Method
Single cell DNA sampling	September 2019 to December 31st, 2020	Can tumor cells and tumor DNA be sampled from blood samples from prostate cancer patients with various advanced disease?

Secondary Outcome Measures

Name	Time	Method
Comparison of novel sampling results to established biomarkers	September 2019 to December 31st, 2020	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?
Single cell DNA sequencing	September 2019 to December 31st, 2020	Can acquired gene defects that may predict treatment be detected by sequencing individual tumor cells, or break-down products, from blood samples?

Trial Locations

Locations (1)

Malarsjukhuset; 🇸🇪 Eskilstuna, Sormland, Sweden