At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- LaserSAFE (diagnostic test)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- LaserSAFE — diagnostic test: The LaserSAFE intervention uses the Histolog® fluorescence confocal microscope to provide real-time tissue visualization at near-cellular resolution.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by University College London, is testing whether confocal microscopy (a special imaging technique) can detect cancer cells at the edges of the prostate during surgery to remove the prostate (called a radical prostatectomy). It focuses on men having robot-assisted surgery for prostate cancer. The aim is to see how well this technique works at spotting cancer remaining at the surgical margins.
Who can take part
- Men diagnosed with operable prostate cancer that has not spread to lymph nodes or other parts of the body (stage cT2-T3a N0 M0)
- Medically fit to have robot-assisted surgery to remove the prostate
- Surgery is planned where nerve-sparing on at least one side is not advised, based on scans, biopsy results and discussions by the medical team
- Able to read English well enough to understand the patient information sheet and give informed consent
Who may not be able to
- Men who had hormone therapy (androgen deprivation therapy) before surgery
- Scans showing either a very low or a very high chance of cancer extending beyond the prostate near the nerves — in other words, only 'in between' cases on scanning are included
- Scans showing the cancer involves the rectum or seminal vesicles, where nerve-sparing would not be safe
- Men who have had previous treatment for prostate cancer, such as radiotherapy, brachytherapy (internal radiation), focal therapy or chemotherapy
What taking part involves
- • Robot-assisted surgery to remove the prostate (radical prostatectomy)
- • During the operation, confocal microscopy is used to check the edges (margins) of the removed tissue for cancer cells
- • Not stated — ask the trial team about any other tests or procedures involved
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves beyond your planned surgery.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Male
- Number of participants
- 693
- Started
- 2026-04-20
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for prostate cancer
- • NA - 693 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with prostate cancer
- • Male only
Where?
- • London - University College London Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Male only
What the study is looking for
- ✓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...
- ✓Ability to read English sufficiently to understand PIS and able to give agreement to take part.
Who cannot take part
- ✗Patients who received neo-after surgery ADT.
- ✗MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score...
- ✗MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or...
- ✗Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is...
- ✗Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal...
See the full criteria
Where Is This Study? (1 UK site)
University College London Hospital NHS Foundation Trust
London NW1 2BU, United Kingdom
How to Get in Touch
Ricardo Almeida-Magana, Dr
Sponsor contactCONTACT