Trial Information

Status:

Open

Specialty:

Prostate

Date Opened:

06/05/2026

Planned Close date:

-

Sponsors:

University Hospitals Of Morecambe Bay NHS Foundation Trust

Site Recruitment:

0 /

50

Principal Investigator:

Prof Alison Birtle

Study Title:

Developing LAMP testing as a diagnostic tool for prostate cancer

Contacts

Research Nurse / Study Coordinator:

Hilary Thatcher

Administrator:

-

Rapid Detection of Prostate Cancer Markers using Loop Mediated Isothermal Amplification – Shining light on the prostate cancer pathway

A case-controlled pilot study of patients undergoing investigations for suspected Prostate Cancer (PC). Participants are asked to provide a sample of blood, urine and saliva to explore new markers for PC. Loop Mediated Isothermal Amplification (LAMP) is a form of molecular analysis that is fast gaining traction in both the medical and veterinary worlds. It relies on the accurate identification of a gene sequence that codes for the causative agent of an infection or the gene sequence within a particular cancer or genetic condition. Preliminary work with LAMP has already identified potential prostate cancer related targets that may be useful, including PCA3 which may aid earlier diagnostics and AR variant 7, known to be an indicator of worse prognosis. This is a proof-of-concept study to identify three key prostate gene sequences within biofluids and compare with patients who are cancer free. Using LAMP it should be possible to distinguish between cancer and non-cancer as well as offer further prognostic information. Patients will have their usual management with MRI, prostate biopsies, confirmation of cancer (or not) by a pathology doctor. We hope this could lead to less invasive and more accurate diagnostic tests for PC.

Patients 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 patients will also have undergone mpMRI as part of standard of care.

Willing and able to give written informed consent.

>16 years of age.

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)

Unwilling and/or unable to give written informed consent.

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

Unable or unwilling to undergo prostate biopsies for any reason.

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

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