Raman Spectroscopy

Trial Info

Status: Open

Specialty: Prostate

Date Opened: 15/Nov/2023

Planned Close Date: 01/Jun/2025

Sponsor: UHMBT

Principal Investigator: Professor Alison Birtle

Study Title: Developing Raman spectroscopy as a diagnostic tool for prostate cancer – A possible alternative to serum PSA (Prostate Specific Antigen) testing and prostate biopsies

Trial Description

Prostate cancer is the most commonly diagnosed male cancer, with more than 52,000 new cases in the UK 2018/191.

Prostate Specific Antigen (PSA) is a blood test used to help diagnose Prostate Cancer (PC). However, raised PSA is not specific for PC and may be due to a urine infection, ejaculation or exercise. If the PSA is high, an MRI scan of the prostate is carried out to check for an abnormal appearance. This is useful but can still miss important cancers especially in younger men (< 50 years) and where the cancer is located in certain areas of the prostate.

MRI is followed by uncomfortable prostate biopsies, which carry a risk of severe infection and bleeding but may still miss significant cancers.

In this study, patients undergoing investigations for suspected PC are asked to provide a sample of blood, urine and saliva to explore new markers for PC.

Raman spectroscopy (RS) is a powerful light-scattering technique that can analyse these samples, providing information on the proteins, fats and carbohydrates, as well as DNA and RNA in these samples. Changes occur in the levels of these with PC, and by identifying these differences, it should be possible to distinguish between cancer and non-cancer.

We already know from other studies that this is possible to see on prostate samples with very good accuracy, but more work is needed to be able to use that information in the clinic to benefit patients quickly.

Patients will have their usual management with MRI, prostate biopsies, confirmation of cancer (or not) by a pathology doctor and with biopsy samples also analysed by RS. The results from blood, urine and saliva are compared between the men with and without PC. We hope this could lead to less invasive and more accurate diagnostic tests for PC.

Inclusion Criteria

1. Men with suspected prostate cancer on the basis of a raised age–specific PSA and/or abnormal digital rectal evaluation who are to undergo prostate biopsy (by either transrectal ultrasound guided biopsies or transperineal template or precision point biopsies). The majority of men will also have undergone mpMRI as part of standard of care.

2. Written informed consent

3. >16 years of age.

Exclusion Criteria

1. Active malignancy within two years prior to study inclusion ( not including non melanomatous skin carcinoma, previous non muscle invasive bladder cancer or in situ carcinoma of any site)

2. Any other conditions that in the Clinial PI opinion would be a contraindication to trial inclusion

3. Unable or unwilling to undergo prostate biopsies for any reason

4. Unable to or unwilling or provide sample of blood, saliva or urine.

5. Men who are subject to safeguarding such as those with dementia, learning disability or those who lack capacity.

For this pilot feasibility study, men who do not have a satisfactory grasp of English will not be approached- due to the patient information sheets being written in English alone for this proof of concept study. However the local population in Morecambe Bay is predominantly English speaking, mainly Caucasian and with very few diagnoses of prostate cancer in the local BAME population, and it is not felt that this feasibility trial will disadvantage other patients in this pilot stage. However should there be an previously unidentified unmet need, this would be discussed with the Study Oversight group PPI members.

Contacts

Research Nurse: Hilary Thatcher

Administrators: research.oncology@mbht.nhs.uk

Link to EDGE

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