Clinical trial · Interventional
Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.
A Single Blinded, IDEAL Stage 3, Multi-Centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) vs Standard Robotic Assisted Radical Prostatectomy (RARP) in Men With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In summary this trial will test whether this new surgical technique can be used to make surgery safer and more effective whilst allowing improved quality of life for patients having surgery for prostate cancer. If the technique is proven effective the investigators will use the experience gained to promote its use throughout the NHS through training courses and publication and dissemination of the resultant data. Staff from centres participating in this trial will be fully trained in the NeuroSAFE technique. A patient and public involvement afternoon was held for participants of the NeuroSAFE PROOF feasibility study, family members, men with prostate cancer, and staff members at UCLH. The event was supported by the charity Orchid Cancer appeal. The high levels of attendance was demonstrative of the support within our patient group for the work of this trial. The trial team listened to the comments made by participants and members of the public and have made some changes to the design of our trial as a result of this feedback.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NeuroSAFE procedure | Procedure | — | UNRESOLVED |
| Standard RARP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NeuroSAFE procedure
- description
- These patients will undergo robotic radical prostatectomy with bilateral nerve spare.The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade.The tissue sample will be snap frozen and embedded in OCT.Using a cryostat, 10 micron thick slices will be placed on slides.The entire length of the area of interest will be sampled in this way generating ≈10 frozen sections per side.The slides will be stained with H\&E and will be examined by a consultant pathologist.As soon as examination is complete the pathologist will telephone the operating surgeon to give the result.Presence of cancer cells at the margin of resection constitutes a positive margin and the neurovascular bundle on that side will be resected if the PSM is present in more than one slice on the same side or for a distance of 3 or more mm.
- interventionNames
- Procedure: NeuroSAFE procedure
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- These patients will undergo robotic radical prostatectomy with a nerve sparing procedure based on surgical planning performed by a consultant radiologist. The mp-MRI will be reviewed by a consultant radiologist along with the details of the prostate biopsy and DRE a decision to perform unilateral, bilateral or non-nerve sparing will be established and recorded in the clinical record form (CRF) for each patient.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men opting to undergo RARP for organ confined prostate cancer. 2. Potent men (IIEF 22-25 not using PDE5i or other medications or vacuum pump) 3. Men who are continent of urine (no self-reported urinary incontinence) 4. Has given written informed consent 5. Ability to read English sufficiently to answer questionnaires and understand PIS Exclusion Criteria: 1. Unable to undergo robotic prostatectomy 2. Known urinary incontinence 3. Previous treatment for prostate cancer 4. Previous/current hormone treatment for prostate cancer 5. Nerve sparing deemed futile due to locally advanced disease by surgeon and radiologist
References
Publications (12)
- BACKGROUNDhttps://doi.org/10.6084/m9.figshare.27054979.v1
- BACKGROUNDBeyer B, Schlomm T, Tennstedt P, Boehm K, Adam M, Schiffmann J, Sauter G, Wittmer C, Steuber T, Graefen M, Huland H, Haese A. A feasible and time-efficient adaptation of NeuroSAFE for da Vinci robot-assisted radical prostatectomy. Eur Urol. 2014 Jul;66(1):138-44. doi: 10.1016/j.eururo.2013.12.014. Epub 2013 Dec 24. PMID 24411279
- BACKGROUNDVasdev N, Agarwal S, Rai BP, Soosainathan A, Shaw G, Chang S, Prasad V, Mohan-S G, Adshead JM. Intraoperative Frozen Section of the Prostate Reduces the Risk of Positive Margin Whilst Ensuring Nerve Sparing in Patients with Intermediate and High-Risk Prostate Cancer Undergoing Robotic Radical Prostatectomy: First Reported UK Series. Curr Urol. 2016 May;9(2):93-103. doi: 10.1159/000442860. Epub 2016 May 20. PMID 27390582
- DERIVEDFang L, Mayor N, Light A, Silvanto A, Haider A, Ng C, Gopalakrishnan A, Boaz RJ, Tanaka MB, Khoubehi B, Hellawell G, Almeida-Magana R, Mendes L, Dinneen E, Shaw G, Challacombe B, Cathcart P, Connor MJ, Shah TT, Ahmed HU, Fiorentino F, Giannarou S, Winkler M. Deep learning for fluorescence confocal microscopy image interpretation in radical prostatectomy. BJU Int. 2026 Jun;138 Suppl 1(Suppl 1):S103-S111. doi: 10.1111/bju.70273. Epub 2026 Apr 19. PMID 42001901
- DERIVEDde Angelis M, Beatrici E, Penaranda NR, Frego N, Resca S, Vecchio E, Barretta A, Ticonosco M, Brancelli C, Cavarra V, Guidotti A, Pepillo F, Prata F, Carl N, Barletta F, Cei F, De Naeyer G, Lambert E, Steen KV, De Groote R, Mottrie A. Intraoperative margin assessment using fluorescence confocal microscopy during robot-assisted radical prostatectomy: a first experience. BJU Int. 2026 Jun;138 Suppl 1(Suppl 1):S40-S48. doi: 10.1111/bju.70262. Epub 2026 Mar 24. PMID 41877464
- DERIVEDSkok K, Scheipner L, Mannweiler S, Kashofer K, Aigelsreiter A, Milosevic I, Leitsmann C, Augustin H, Rossmann-Tsybrovskyy M, Ahyai S, Liegl-Atzwanger B, Mischinger J. Feasibility and workflow analysis of confocal microscopy in robot-assisted prostatectomy. BJU Int. 2026 Jun;138 Suppl 1(Suppl 1):S77-S87. doi: 10.1111/bju.70157. Epub 2026 Feb 8.