Clinical trial NCT04101305: Measurement of Circulating Tumor Cells in Prostate Cancer
Official title: Measurement of Circulating Tumor Cells in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Keywords: Prostate cancer, biomarker
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: iCellate Medical
First posted: 2019-09-24
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the urology clinic for investigation of a suspected urologic condition

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.

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

Primary outcomes:
measure: Single cell DNA sampling
timeFrame: September 2019 to December 31st, 2020
Secondary outcomes:
measure: Comparison of novel sampling results to established biomarkers
timeFrame: September 2019 to December 31st, 2020
measure: Single cell DNA sequencing
timeFrame: September 2019 to December 31st, 2020
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Malarsjukhuset
state: Sormland
Study officials:
affiliation: Region Sormland
name: Evangelos Digkas, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Castro et al., Surgery Curr Res 2012, 2:3 http://dx.doi.org/10.4172/2161-1076.1000113
citation: Castro et al., J Integr Oncol 2018, 7:3 DOI: 10.4172/2329-6771.1000212
citation: Castro et al., Disease Markers Volume 2018, Article ID 4653109, 5 pages https://doi.org/10.1155/2018/4653109