Trial Stages & Recruitment

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.
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Sites
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Participants Recruited
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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

7th August 2020

150th 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...