Trial Outcomes & Findings for Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy. (NCT NCT03317990)

Last Updated: 2025-09-04

Results Overview

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 Measure Description: The International Index of Erectile Function-5 (IIEF-5) measures erectile dysfunction severity. Total scores range from 5 to 25, calculated by summing 5 items. Higher scores indicate better erectile function. Severity categories: 22-25 = no erectile disfunction, 17-21 = mild, 12-16 = mild to moderate, 8-11 = moderate, 5-7 = severe. No subscales are used; the total score is the sum of all items.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

407 participants

Primary outcome timeframe

1 year

Results posted on

2025-09-04

Participant Flow

A total of 364 evaluable participants were required to have 80% power to detect such difference, with a two-sided α of 5%. Allowing for a 10% dropout rate, we aimed to recruit 404 participants (202 per group).

Participant milestones

Participant milestones
Measure	NeuroSAFE Procedure 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.	Control 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.
Overall Study STARTED	204	203
Overall Study Patients Who Underwent Surgery	190	191
Overall Study COMPLETED	174	173
Overall Study NOT COMPLETED	30	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only patient with known race/ethnicity data were included, the rest have missing data

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 year

Population: Participants with available data

Outcome measures

Outcome measures
Measure	NeuroSAFE Procedure n=173 Participants 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.	Control n=171 Participants 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.
Erectile Function	12.7 units on a scale Standard Deviation 8.0	9.7 units on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 3 months

Population: Participants with available data

Comparison of the continence at 3 months, measured using the ICIQ questionnaire between intervention and control arms. o Additional subgroup analysis: restricted to men who did not receive a pre-operative radiologist recommendation for bilateral nerve sparing The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) assesses the frequency, severity, and impact of urinary incontinence. Total scores range from 0 to 21, with higher scores indicating more severe symptoms. Scores are calculated by summing 3 scored items. No subscales are used; higher values represent worse outcomes.

Outcome measures

Outcome measures
Measure	NeuroSAFE Procedure n=158 Participants 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.	Control n=158 Participants 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.
Functional Outcome - Urinary Continence	5.8 units on a scale Standard Deviation 4.1	7.4 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data

Outcome measures

Outcome measures
Measure	NeuroSAFE Procedure n=145 Participants 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.	Control n=158 Participants 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.
Functional Outcome - Urinary Continence at 6 Months	4.5 units on a scale Standard Deviation 4.2	5.1 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 12 months after surgery

Population: Participants with available data

Oncological outcome will be classified into four categories according to the following definition: 1. PSA persistence : PSA≥0.2 at visit 2 2. Biochemical recurrence: (PSA less than 0.2 at visit 2) and (PSA≥0.2 at visit 3 or PSA≥0.2 at visit 4) 3. Early salvage treatment: (PSA less than 0.2 at each of visit 2, visit 3, and visit 4) and (received adjuvant treatment in the first year) 4. Other (No recurrence or treatment): (PSA less than 0.2 at each of visit 2, visit 3, and visit 4) and did not receive adjuvant treatment

Outcome measures

Outcome measures
Measure	NeuroSAFE Procedure n=182 Participants 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.	Control n=188 Participants 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.
Oncological Outcome PSA persistance	7 Participants	5 Participants
Oncological Outcome Biochemical recurrence	10 Participants	7 Participants
Oncological Outcome Adjuvant treatment	8 Participants	2 Participants
Oncological Outcome Other (no recurrence or treatment)	157 Participants	174 Participants

SECONDARY outcome

Timeframe: 12 months and 24 months

A comparison of the proportion of men achieving the best quality of life according to the EQ-5D-5L between intervention and control arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months and 24 months

Analysis of EQ-5D-5L scores to produce QALYs at 12 months by arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the time of intervention

Population: Participants with available data

Descriptive tabulation of PSM rates between NeuroSAFE RARP and standard RARP arms. PSMs will be grouped as: 1. Negative surgical margins 2. Small single positive surgical margin 3. Large or multifocal surgical margin

Outcome measures

Outcome measures
Measure	NeuroSAFE Procedure n=190 Participants 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.	Control n=191 Participants 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.
Oncological Outcomes - Positive Surgical Margins Negative	124 Participants	137 Participants
Oncological Outcomes - Positive Surgical Margins Small single positive surgical margin	40 Participants	24 Participants
Oncological Outcomes - Positive Surgical Margins >3 mm or multifocal positive surgical margin	26 Participants	30 Participants

SECONDARY outcome

Timeframe: 12 months and 24 months

Use of the Health Economics Questionnaires to inform a health cost analysis of NeuroSAFE RARP vs. standard RARP. * Economic analysis to assess healthcare resources use by arm and cost analysis to assess: * Cost of intervention and control * Cost of NHS resource use (medications, physiotherapy, * Cost of private health care resources (medication, physiotherapy) * Other private/societal costs (productivity losses, caregivers costs, out of pocket cost for transport, equipment)

Outcome measures

Outcome data not reported

Adverse Events

NeuroSAFE Procedure

Serious events: 6 serious events

Other events: 0 other events

Deaths: 2 deaths

Control

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	NeuroSAFE Procedure n=190 participants at risk 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.	Control n=191 participants at risk 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.
Renal and urinary disorders Postoperative haematuria	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Gastrointestinal disorders Gastric ulcer	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.00% 0/191 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Infections and infestations Urinary tract infection	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.00% 0/191 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
General disorders Unrelated hospital readmission	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.00% 0/191 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Blood and lymphatic system disorders Postoperative haemorrhage	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.00% 0/191 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Blood and lymphatic system disorders Pelvic haematoma	0.53% 1/190 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Renal and urinary disorders Urethro-vesical anastomosis leak	0.00% 0/190 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Gastrointestinal disorders Acute appendicitis	0.00% 0/190 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Respiratory, thoracic and mediastinal disorders Incidental non-tension pneumothorax	0.00% 0/190 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery
Renal and urinary disorders Infected scrotal haematoma	0.00% 0/190 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery	0.52% 1/191 • Number of events 1 • From surgery to 90 postoperative days Adverse events and serious adverse events occurring within 90 days of surgery were reported descriptively, numbers reflect patients who had surgery

Other adverse events

Adverse event data not reported

Additional Information

Professor Greg Shaw

University College London

Phone: +44 (0)20 7679 2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	NeuroSAFE Procedure n=190 Participants 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.	Control n=191 Participants 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.	Total n=381 Participants Total of all reporting groups
Age, Continuous	57.8 Years STANDARD_DEVIATION 6.4 • n=190 Participants	57.3 Years STANDARD_DEVIATION 7 • n=191 Participants	57.5 Years STANDARD_DEVIATION 6.7 • n=381 Participants
Sex: Female, Male Female	0 Participants n=190 Participants	0 Participants n=191 Participants	0 Participants n=381 Participants
Sex: Female, Male Male	190 Participants n=190 Participants	191 Participants n=191 Participants	381 Participants n=381 Participants
Race/Ethnicity, Customized Ethnicity · White	108 Participants n=171 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	103 Participants n=169 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	211 Participants n=340 Participants • Only patient with known race/ethnicity data were included, the rest have missing data
Race/Ethnicity, Customized Ethnicity · Black	49 Participants n=171 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	53 Participants n=169 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	102 Participants n=340 Participants • Only patient with known race/ethnicity data were included, the rest have missing data
Race/Ethnicity, Customized Ethnicity · Asian	9 Participants n=171 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	9 Participants n=169 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	18 Participants n=340 Participants • Only patient with known race/ethnicity data were included, the rest have missing data
Race/Ethnicity, Customized Ethnicity · Other/Mixed	5 Participants n=171 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	4 Participants n=169 Participants • Only patient with known race/ethnicity data were included, the rest have missing data	9 Participants n=340 Participants • Only patient with known race/ethnicity data were included, the rest have missing data
Baseline PSA	9.1 Ng/ml STANDARD_DEVIATION 6.5 • n=188 Participants • Only patient with known BMI data were included, the rest have missing data	8.6 Ng/ml STANDARD_DEVIATION 5.9 • n=191 Participants • Only patient with known BMI data were included, the rest have missing data	8.9 Ng/ml STANDARD_DEVIATION 6.2 • n=379 Participants • Only patient with known BMI data were included, the rest have missing data
Clinical T-Stage T-1	7 Participants n=180 Participants • Only patients with known T staging classification were included, rest have missing data	6 Participants n=179 Participants • Only patients with known T staging classification were included, rest have missing data	13 Participants n=359 Participants • Only patients with known T staging classification were included, rest have missing data
Clinical T-Stage T-2	135 Participants n=180 Participants • Only patients with known T staging classification were included, rest have missing data	132 Participants n=179 Participants • Only patients with known T staging classification were included, rest have missing data	267 Participants n=359 Participants • Only patients with known T staging classification were included, rest have missing data
Clinical T-Stage T-3	38 Participants n=180 Participants • Only patients with known T staging classification were included, rest have missing data	41 Participants n=179 Participants • Only patients with known T staging classification were included, rest have missing data	79 Participants n=359 Participants • Only patients with known T staging classification were included, rest have missing data
Cambridge Prognostic Group 1	6 Participants n=177 Participants • Only patients with complete staging information were included in this analysis	4 Participants n=179 Participants • Only patients with complete staging information were included in this analysis	10 Participants n=356 Participants • Only patients with complete staging information were included in this analysis
Cambridge Prognostic Group 2	80 Participants n=177 Participants • Only patients with complete staging information were included in this analysis	83 Participants n=179 Participants • Only patients with complete staging information were included in this analysis	163 Participants n=356 Participants • Only patients with complete staging information were included in this analysis
Cambridge Prognostic Group 3	38 Participants n=177 Participants • Only patients with complete staging information were included in this analysis	40 Participants n=179 Participants • Only patients with complete staging information were included in this analysis	78 Participants n=356 Participants • Only patients with complete staging information were included in this analysis
Cambridge Prognostic Group 4	46 Participants n=177 Participants • Only patients with complete staging information were included in this analysis	44 Participants n=179 Participants • Only patients with complete staging information were included in this analysis	90 Participants n=356 Participants • Only patients with complete staging information were included in this analysis
Cambridge Prognostic Group 5	7 Participants n=177 Participants • Only patients with complete staging information were included in this analysis	8 Participants n=179 Participants • Only patients with complete staging information were included in this analysis	15 Participants n=356 Participants • Only patients with complete staging information were included in this analysis
BMI	27.3 kg/m^2 STANDARD_DEVIATION 3.8 • n=190 Participants	27.1 kg/m^2 STANDARD_DEVIATION 3.4 • n=191 Participants	27.2 kg/m^2 STANDARD_DEVIATION 3.6 • n=381 Participants
Baseline IIEF-5 Score	23.3 units on a scale STANDARD_DEVIATION 2.2 • n=190 Participants	23.3 units on a scale STANDARD_DEVIATION 2.5 • n=191 Participants	23.3 units on a scale STANDARD_DEVIATION 2.4 • n=381 Participants
Prostate volume	38.1 cm^3 STANDARD_DEVIATION 17.6 • n=190 Participants	39.7 cm^3 STANDARD_DEVIATION 20.1 • n=191 Participants	38.9 cm^3 STANDARD_DEVIATION 18.9 • n=381 Participants