Prostate cancer in-vitro diagnostic assay validation Cancer Malignant neoplasm of prostate
Conditions
Interventions
Aside from taking of blood samples on one occasion, the study is non-interventional.
Sponsors
Biosignatures Limited (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Are between 40 and 80 years of age 2. Are considered to possibly have an undiagnosed prostate cancer 3. Are considered suitable for prostate biopsy 4. Are able to provide written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out
Exclusion criteria
Exclusion criteria: 1. Are known to currently have another cancer or have been treated for cancer within the last five years 2. Are not considered suitable for prostate biopsy 3. Are outside of the target age range 4. Are infected with HIV, a viral Hepatitis or another highly-infectious blood-borne disease 5. Are incapable of providing written informed consent agreeing to participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A validation of the performance of the Biosignatures BiopSave product, demonstrating the capability of this proteomic blood test to predict the diagnostic results of prostate biopsies carried out on patients presenting for assessment at urology clinic with the suspicion of having an undiagnosed prostate cancer, particularly those patients in a specific sub-set: PSA concentration between 2.5 and 20 ng/ml, DRE findings not immediately suspicious of prostate cancer, have not undergone previous prostate biopsy or resection procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. A validation of the performance of the BiopSave product in patients who have a PSA concentration outside of the primary range of interest and/or who have DRE findings which are suspicious of prostate cancer and/or who have had prostate biopsy or resection procedures carried out in the past. 2. A comparison of the performance of the BiopSave product to a variety of other prostate disease biomarkers recently reported in the literature. 3. An assessment of the capability of the BiopSave product, or related refined versions of the assay to predict the overall prostate disease diagnostic status of study participants one year after initial prostate biopsy. | — |
Countries
United Kingdom
Outcome results
None listed