Plain English Summary
PR-CT-001 2012/July (02)
BiopSave: a blinded, prospective, non-randomised observational controlled study to validate a novel proteomic blood test for the diagnosis of prostate cancer
It is hypothesised that a panel of candidate biomarkers, identified during an earlier pilot study as being present in the blood of prostate cancer patients, can be measured using the Biosignatures proteomics platform and successfully used to predict the likelihood of a patient having prostate cancer diagnosed by prostate biopsy. Diagnostic predictions will be made blinded to biopsy result and the accuracy of these predictions compared to actual biopsy results at designated analysis milestones by an independent data monitoring committee. The null hypothesis is that the candidate biomarkers identified during the pilot study had a coincidental association with the patients known to have prostate cancer in that cohort and therefore have no ability to make diagnostic predictions regarding the likelihood of prostate cancer being detected by prostate biopsy in newly recruited patients.
On 16/03/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 12/09/2014 to 31/03/2017.
2. The target number of participants was changed from 500 to 800.
3. The study design was changed from 'Two-year blinded prospective non-randomised controlled observational study' to 'Blinded prospective non-randomised controlled observational study, with an anticipated duration of 54 months'.
NRES Committee South Central - Oxford C, 19/07/2012, ref: 12/SC/0432
Blinded prospective non-randomised controlled observational study, with an anticipated duration of 54 months
Primary study design
Secondary study design
Non randomised controlled trial
Patient information sheet
Prostate cancer in-vitro diagnostic assay validation
Aside from taking of blood samples on one occasion, the study is non-interventional.
Primary outcome measures
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 outcome measures
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.
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The Freeman Hospital
Biosignatures Limited (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Results will be published in specialist urology journals following un-blinding and pivotal data analysis.
Intention to publish date
Participant level data
Available on request
Results - basic reporting