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

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. Identifier: NCT03317990
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : December 22, 2020
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 454 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, Multi-Centre, Randomised Controlled Trial to Evaluate NeuroSAFE Robotic Assisted Radical Prostatectomy (RALP) vs Standard Robotic Assisted Radical Prostatectomy (RALP) in Men With Prostate Cancer
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2022

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.

No Intervention: 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.

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

    Erectile function according to question 3 of the IIEF questionnaire validated patient reported outcome measure (PROM) questionnaire at 12 months.

    3. Over the past 4 weeks when you attempted sexual intercourse, how often were you able to penetrate (enter) your partner?

    The question rated on a scale outlined below:

    Did not attempt intercourse .……………...…….. 0 Almost never/never ……………………………... 1 A few times (much less than half the time) ….... 2 Sometimes (about half the time) …………..…... 3 Most times (much more than half the time) …... 4 Almost always/always ……………….………….. 5

Secondary Outcome Measures :
  1. Oncological Outcomes - rates of Positive Surgical Margins [ Time Frame: 5 years after surgery ]
    Rates of Positive Surgical Margins as reported by pathologists (number of margins)

  2. Oncological Outcomes - rates of BCR [ Time Frame: 5 years after surgery ]
    Rates of biochemical reoccurrence (BCR) as reported by PSA results (number of patients)

  3. Oncological Outcomes - rates of adjuvant therapies [ Time Frame: 5 years after surgery ]
    Rates of adjuvant therapies as reported by follow up visits (number of adjuvant therapies)

  4. Health economics - cost of treatment for incontinence, impotence, travel and adjuvant treatment [ Time Frame: 2 years from surgery ]
    Cost of treatment for incontinence, impotence and adjuvant treatment. The cost for patients to travel to and from the hospital will also be recorded in a health economic diary. This inforamtion will be taken at each visit and analysed by a health economist after data lock.

  5. Functional outcomes (excluding erectile function) - ICIQ PROM [ Time Frame: 2 years ]
    Validated PROM questionnaires related to continence (ICIQ) - (measured on a scale 0 - 21, with 21 indicating severe incontinence and 0 being dry)

  6. Functional outcomes (excluding erectile function) - EQ5D5L quality of life questionnaire [ Time Frame: 2 years ]
    Validated PROM questionnaire related to quality of life. Scale is 1-5 with 1 having no limitations to everyday life and 5 being a severely diminished quality of llife

  7. Functional outcomes (excluding erectile function) - RAND36 quality of life questionnaire [ Time Frame: 2 years ]
    Validated PROM questionnaire related to quality of life. Scale is 1-5 with 1 indicating a good quality of life/excellent health and 5 being a significant reduction in quality of life/poor health.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males can develop prostate cancer
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men opting to undergo RALP 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 identifier (NCT number): NCT03317990

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Contact: Jack D Grierson, MRes 0207 679 9280
Contact: Jack D Grierson, MRes

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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         
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
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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 Identifier (NCT Number):
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Responsible Party: University College, London Identifier: NCT03317990    
Other Study ID Numbers: 220262
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
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
Frozen section
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases