NCT07541911 A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy
| NCT ID | NCT07541911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 693 participants |
| Start Date | 2026-04-20 |
| Primary Completion | 2030-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 693 participants in total. It began in 2026-04-20 with a primary completion date of 2030-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to find out whether a new method called "LaserSAFE" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery. The main questions it aims to answer are: Can LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves? Researchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice. Participants will: Complete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and 12 months after surgery
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with clinically significant operable cT2-T3a N0 M0 PC. * Medically fit to undergo RARP. * Scheduled for robot-assisted RARP with a recommendation against intrafascial nerve sparing on at least 1 side based on multidisciplinary meetings informed by MRI, biopsy result and clinical factors. * Ability to read English sufficiently to understand PIS and able to give informed consent. Exclusion Criteria: * Patients who received neo-adjuvant ADT. * MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score or tumour away from the posterolateral areas of the prostate) * MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or bulging tumour on MRI T2 images) * Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is deemed not feasible due to oncological safety concerns. * Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.
Contact & Investigator
Greg Shaw, Professor
PRINCIPAL INVESTIGATOR
University College, London
Frequently Asked Questions
Who can join the NCT07541911 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07541911 currently recruiting?
Yes, NCT07541911 is actively recruiting participants. Contact the research team at r.magana@ucl.ac.uk for enrollment information.
Where is the NCT07541911 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07541911 clinical trial?
NCT07541911 is sponsored by University College, London. The principal investigator is Greg Shaw, Professor at University College, London. The trial plans to enroll 693 participants.
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