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Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy. (NeuroSAFEPROOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317990
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : May 13, 2022
Sponsor:
Collaborators:
North Bristol NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University College London Hospitals
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
University College, London

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: NeuroSAFE procedure Procedure: Standard RARP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single blinded, multi-centre, randomised controlled trial. Parallel group, two-arm, with 1:1 allocation ratio between nerve sparing guided by NeuroSAFE and current UK practice (guided by MRI, biopsy and clinical examination).
Masking: Single (Participant)
Masking Description: Patients will be blinded as to whether the person has had NeuroSAFE procedure. The surgeon and pathologist cannot be blinded to this.
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 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
Procedure: NeuroSAFE procedure
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 positive margin is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.
Other Name: NeuroSAFE RARP

Active Comparator: 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.
Procedure: Standard RARP
Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis




Primary Outcome Measures :
  1. Erectile Function [ Time Frame: 1 year ]

    Comparison of the proportion of men who recover 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, where recovered function is defined as a score of 21 or more.

    o Pre-defined sub-group analysis: comparison of the proportion of men who recover 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



Secondary Outcome Measures :
  1. Functional outcome - Urinary Continence [ Time Frame: 3 and 6 months after surgery ]

    Comparison of the proportion of men who are continent at 3 months, measured using the ICIQ questionnaire, where continence is defined as a score of 5 or less 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


  2. Oncological Outcomes - Biochemical recurrence (BCR) [ Time Frame: 12 months after surgery ]
    Comparison of the proportion of men with BCR between NeuroSAFE and control arms within 12 months of surgery. BCR is defined as PSA>0.2 ng/ml post-surgery at any time during the 12 months.

  3. Oncological Outcomes - Additional oncological treatments [ Time Frame: 12 months after surgery ]

    'Adjuvant treatment' refers to men who undergo additional cancer treatment without having BCR. A descriptive analysis of the proportion of men undergoing adjuvant oncological treatments (ADT and/or radiotherapy and/or chemotherapy) at or before 12 months of surgery will be conducted.

    'Salvage treatment' refers to men who undergo additional cancer treatment following BCR. A descriptive analysis of the proportion of men undergoing adjuvant oncological treatments (ADT and/or radiotherapy and/or chemotherapy) at or before 12 months of surgery will be conducted.


  4. Quality of life - EQ-5D-5L [ Time Frame: 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.

  5. Quality of life - EQ-5D-5L Score [ Time Frame: 12 months and 24 months ]
    Analysis of EQ-5D-5L scores to produce QALYs at 12 months by arm

  6. Quality of life - RAND36 [ Time Frame: 12 months and 24 months ]
    Analysis of RAND36 scores to produce QALYs at 12 months by arm

  7. Oncological Outcomes - Positive surgical margins [ Time Frame: At the time of intervention ]

    Descriptive tabulation of PSM rates between NeuroSAFE RARP and standard RARP arms. PSMs will be grouped as:

    0. Negative margin

    1. Intraprostatic margins
    2. Non-intraprostatic margins ≤ 1mm (included)
    3. Large non-intra prostatic margins and >1mm
    4. Very large non-intraprostatic margins and >3mm and/or multifocal

      • Additional subgroup analysis: restricted to men who did not receive a pre-operative radiologist recommendation for bilateral nerve sparing.

  8. Health Economic Analysis [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 overactive bladder
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317990


Contacts
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Contact: Greg L Shaw, MD 02076795279 ncita.neurosafe@ucl.ac.uk
Contact: Nicola C Muirhead, PhD ncita.neurosafe@ucl.ac.uk

Locations
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United Kingdom
North Bristol NHS Trust Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Raj Persad         
NHS Greater Glasgow & Clyde Recruiting
Glasgow, United Kingdom
Contact: Imran Ahmad, PhD, MRCS         
University College London Hospital Recruiting
London, United Kingdom, NW1 2BU
Contact: Greg Shaw, MD         
Nottingham University Hospitals Recruiting
Nottingham, United Kingdom
Contact: Tom Walton         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Neil Oakley, MD         
Sponsors and Collaborators
University College, London
North Bristol NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University College London Hospitals
NHS Greater Glasgow and Clyde
Investigators
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Principal Investigator: Greg L Shaw, MD University College, London
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03317990    
Other Study ID Numbers: 220262
17/0443 ( Other Grant/Funding Number: University College London )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be anonymised at source. Only anonymised data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Prostate Cancer
Nerve sparing
NeuroSAFE
Frozen section
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases