The Patient Journey
Approach
Patients are approached by the trial and given a Patient Information Sheet. They then have time to ask questions and see if they would be interested in becoming a participant.
Consent
Once patients feel they have fully understood the trial and want to participate, they will sign an informed consent form and become an enrolled NeuroSAFE PROOF Participant
Randomise
Once enrolled, a computer randomly allocates participants to either the standard radical prostatectomy arm, or the radical
prostatectomy with NeuroSAFE technique arm.
Participants will be blinded and will not know which group they are in
Operate
All patients will then undergo radical prostatectomy in line with the current standard of care.
Half of participants will also undergo the NeuroSAFE technique.
Follow up
Participants will then be followed up by the trial team at 3 months, 6 months, 1 year and 2 years after surgery. This will include Quality of Life questionnaires about patient's recovery, and physical health and wellbeing.
Discharge
After their 2 year follow up, participants are referred back to their home hospital.
The research team will continue to follow up participants through their medical records at 3, 4, and 5 years post surgery.
0
Sites
50
Participants Recruited
0 +
Questionnaires Collected
The NeuroSAFE PROOF Trial
A national multi-centre collaborative study
NeuroSAFE PROOF Feasibility study
Feasibility studies are an important step in creating a full trial. They help answer questions like: Can this study be done? Are we able to recruit enough patients? Is this the best method? Is there anything we could improve?
November 2017
The National Institute for Health Research (NIHR) grant £250,000 for the NeuroSAFE PROOF Feasibility study
December 2017
Ethical approval
9th April 2018
UCLH site open
20th April 2018
First patient enrolled
20th September 2018
First Patient and Public Involvement event
NeuroSAFE PPI Day 2018
On the 20th of September 2018 the NeuroSAFE PROOF Trial Team hosted a Public Information Afternoon at UCLH for men and their loved ones to find out more about the work of the NeuroSAFE Project...
9 November 2018
Bristol site open
26th November 2018
First Bristol patient
4th January 2019
Last Feasibility patient (50th patient) recruited
29th January 2019
JP Moulton grant £600,000 for the NeuroSAFE PROOF full RCT study
NeuroSAFE PROOF Full Randomised Controlled Trial
1st February 2019
First full RCT patient
April 2019
Nominated for the HSJ Value Award 2019 - Surgical services initiative of the year
30th May 2019
Sheffield site open
5th July 2019
First Sheffield patient
17th July 2019
Glasgow site open
20th September 2019
First Glasgow patient
1st November 2019
100th Patient!
17th March 2020
Trial recruiment paused due to the Covid-19 pandemic
17th June 2020
Trial re-opened
21st July 2020
Second NeuroSAFE PPI event
August 2020
150th Patient!
July 2021
200th Patient!
NeuroSAFE PPI Day 2020
On the 21st of July, the NeuroSAFE PROOF clinical research team conducted their first ever virtual Public & Patient Involvement (PPI) Session, talking to over 35 men with prostate cancer about their research and discussing patients’ priorities for future work by the team...
