Study Status

Having reached our aims the study will now close, however we WILL RE-START.

Following publication of results and after securing further funding we aim to restart recruitment with some amendments, using what we have learned from the pilot study.

If you express an interest to be involved in the study please do contact us so we may contact you regarding this study in the future when it restarts.

When is the study starting and how long is it expected to run for?

The PROSPECT study started in September 2020 and ran initially for two years. If the study results from the two years show the design to be acceptable to patients, we expect PROSPECT to run for at least ten years.

Why is PROSPECT happening?

Usually Clinical Trial data is collected hear to head, randomised controlled trials of a new treatment(s) and its compared to an established treatment

This has some challenges. The treatment allocation is based on chance which many patients don’t like. Patients and clinicians alike often share strong preferences for a particular treatment.

Often, trials then do not recruit enough patients to achieve their goals.

How does our trial differ?

When there are any innovative approaches, interventions, treatments or changes in management to prostate conditions, it might have a significant patient benefit and impact on the NHS. PROSPECT wants to evaluate a new way of running clinical trials that can incorporate these new treatment options into their randomisations.

Crucially, those invited would not be obliged to undergo that trial test or treatment if they didn’t feel it was right for them.

Men who have been referred for further investigations due to elevated PSA, lower urinary tract symptoms or abnormal rectal examination Consent to 1. COHORT inclusion

Refused Consent

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Time

In pilot phase of PROSPECT, we wanted to see if patients would accept joining the study cohort. That meant a group of men referred for prostate investigations who will always be offered NHS standard of care tests and treatments, but in addition, may also be offered trial tests and treatment alongside this.

“Practical or ethical obstacles to randomisation can sometimes be overcome by the use of non-standard designs. Where patients have very strong preferences among treatments, basing treatment allocation on patients’ preferences, or randomising patients before seeking consent, may be appropriate.”

--Mr Edward Bass

– PROSPECT Trial Co-Ordinator

What does the study involve?