Here is the design of a clinical trial:

Official Title: 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

Included conditions:
- Prostate Cancer

Study Armgroups:
- {'label': 'NeuroSAFE procedure', 'type': 'EXPERIMENTAL', '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']}
- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', '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.', 'interventionNames': ['Procedure: Standard RARP']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'NeuroSAFE procedure', 'description': 'When the prostate is removed from within the patient as it is disconnected from its attachments. The specimen will then be painted (right=blue, left =black) by the operating surgeon and delivered expediently to the pathologist who will perform frozen section analysis of the painted areas. 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. If a significant positive margin (on more than one section from one side or in a single section but greater than or equal to 3mm) is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.', 'armGroupLabels': ['NeuroSAFE procedure'], 'otherNames': ['NeuroSAFE RARP']}
- {'type': 'PROCEDURE', 'name': 'Standard RARP', 'description': 'Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis', 'armGroupLabels': ['Control']}

Primary Outcomes:
- {'measure': 'Erectile Function', 'description': 'Comparison of the erectile function at 12-months according to allocated treatment arm (i.e. NeuroSAFE RARP \\[intervention\\] vs. standard RARP \\[control\\]). Erectile function is measured using the IIEF-5 questionnaire\n\no Pre-defined sub-group analysis: comparison of the erectile function at 12-months according to treatment arm, restricted to men who did not receive a pre-operative radiologist recommendation for bilateral nerve sparing', 'timeFrame': '1 year'}

Please estimate the sample size based on the assumption: 
90% power, alpha of 0.05, loss to follow-up rate of 10%
Sample size {14}
          Sample size calculation was based on the results of the NeuroSAFE PROOF feasibility study data. Patients from the feasibility study will not be included in the main trial analysis. A sample of 416 patients (374 evaluable) is needed to detect a 14% or higher difference between groups with 90% power, alpha of 0.05, and a loss to follow-up rate of 10%. EF preservation rates from the feasibility study have not been presented here to protect equipoise and because the feasibility study was not powered to detect treatment effect estimates. The Independent Data Monitoring Committee (IDMC) reviewed the sample size assumptions on 16 February 2021, unblinded to results from the first 150 men recruited to the main trial and advised the study to continue recruitment to the original number of 404 men (364 evaluable men). The IDMC has continued reviewing the recruitment target during the trial.