Real-time prostate cancer diagnosis - Surgical guidance in adult patients

Condition is prostate cancer. One off biopsy sample. The principal aim of the study is to demonstrate in vivo (intraoperative) prostate cancer diagnosis and grading. The participants will receive routine standard of care for their procedure. During the procedure, the clinician will perform two or three in vivo measurements using our instrument. The exact number of measurements for each patient is at the clinician's sole discretion. No clinical decision is made using the Raman data. All clinical decisions strictly follow the current standard of care and are independent of the study. The Raman measurements take 20 seconds. The study will increase the overall clinical procedure time by no more than 1-2 min. The Raman data will be compared to post-procedure histopathology results. Patients are not contacted after the procedure. All participants have a suspicion of prostate cancer due to an elevated PSA level or MRI data showing suspicious regions. ---- Equipment used: 1. In vivo measurements completed in this study: Raman spectroscopy measurements 2. Instrument will be used to take these measurements: Raman spectrometer (HT-SPEC-785-03] 3. Sterilised custom-designed Raman probes. These probes are 18 gauge in diameter. They have been designed to comply with medical-grade equipment guidelines. ---- Measurement protocol: 1- Measurement protocol during routine biopsy screening procedures. Measurement steps: i. The patient will be prepared per standard clinical protocols for the biopsy procedure. ii. The surgeon will proceed with normal biopsy collection procedure. When at a location of interest for our study iii. The surgeon will place the optical probe inside the current guiding equipment. iv. The optical probe will be guided to the location of interest through the guiding sheath. v. Once in place, the surgeon will trigger the measurement. One measurement takes about 5 to 7 seconds, and we will take up to 3 measurements. vi. When the measurements are completed, the surgeon will remove the optical probe. From this point, the clinician will return to the standard clinical care protocols. vii. The surgeon continues with the standard biopsy collection procedure. The optical probe will then be cleaned and sterilised. The optical probes will be decontaminated using Tristel Trio wipes system as recommended by the clinical team. The guiding tools used are all sterile disposable tools. The Tristel Trio Wipes System is a comprehensive solution for the decontamination of semi-critical, non-lumened medical devices. It combines cleaning, high-level disinfection and rinsing with traceability. The surgeon alone will decide how many locations of interest they will measure with our optical probe to ensure the best clinical outcome for the patient and maintain minimum disruption to the clinical workflow. A standard biopsy collection procedure takes between 45 min and 1h. We will ensure that our study does not extend the duration of the standard procedure by more than 3 to 4 minutes. 2- In vivo measurements during routine prostatectomy procedures using the SORS probe. Measurement steps: i. Using standard clinical care protocols, the surgeon will remove part of, or the entire, prostate as predefined and agreed upon with the patient to ensure best clinical outcome. Our study does not influence these decisions. ii. When appropriate and at his discretion, the surgeon will use our probe to assess specific areas of the surgical margins where they want to take a biopsy sample. One measurement takes about 15 seconds. From this point, the clinician will return to the standard clinical care protocols. iii. After measuring the area with our probe, the surgeon will take a biopsy sample iv. The biopsy samples will follow standard clinical workflow. The surgeon alone will decide how many locations of interest they will measure with our optical probe to ensure the best clinical outcome for the patient and maintain the clinical workflow. On average, a prostatectomy procedure takes between 1h30min to 2h. We will ensure that measurements with our optical probe do not extend the duration of the standard procedure by more than 8 to 10 minutes. It is part of a routine operation and the patient is assessed as per standard of care by hospital staff.