Clinical trial NCT05355727: PROSAIC-DS Study (PROState AI in Cancer - Decision Support)
Official title: PROSAIC-DS (PROState AI in Cancer - Decision Support): Evaluation of the Deontics AI Platform for Evidence-based Treatment Planning in Multidisciplinary Cancer Care: Increasing Compliance and Streamlining MDTs in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
name: King's College London
name: Deontics Limited
name: Somerset NHS Foundation Trust
name: Prostate Cancer UK
First posted: 2022-05-02
Enrollment: 1040
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Around 375,000 cancers are diagnosed in the UK annually, with this figure expected to reach 500,000 by 2035. As the number of different cancer treatment options and our scientific understanding continue to grow rapidly, it can be difficult for clinicians to keep up-to-date with best practice, causing unjustified variations in the quality of care and clinical outcomes for patients.

Currently, when a patient has been referred to and seen by a clinician, their treatment is then discussed in a Multi-Disciplinary Team Meeting (MDTM). MDTM is a meeting of medical experts, including Surgeons, Oncologists, Nurses, and specialists in cancer, imaging and diagnosis. This is the case even if a treatment decision is straightforward.

A nationwide review published by CRUK in 2017 highlighted the demands on cancer teams and the MDTM process:

* Increased caseloads are causing dramatic increases in the time spent by clinicians in MDTMs, leading to an unsustainable rise in costs: the cost in England has increased from £88m to £159m in 4 years;
* There is not enough time in the MDTM to discuss complex cases;
* There is a failure to involve patients in the decision-making process: around 75% of patients feel their views are unrepresented in MDTMs; In our study we are looking at the potential of technology - particularly Clinical Decision Support Systems (CDSS) - to improve MDTM decision making.

Deontics has a CE marked AI-based CDSS that integrates individual patient data and preferences with evidence-based clinical guidelines. This dynamically and transparently generates best-practice, individualised treatment recommendations which can help determine treatment. Deontics' AI tool has already been shown to provide personalised recommendations concordant with UK best practice while incorporating patient values, and can be used to safely triage less complex patients straight to treatment with minimal clinical oversight. Our project partners with Deontics to develop PROSAIC-DS - A CDSS for prostate cancer.

Detailed description: I

Eligibility criteria: Inclusion Criteria:

* All patients referred to the GSTT and KCH Prostate MDT meetings where sufficient information is available for the MDT to make a treatment decision (approximately 40-50 per week) will be eligible for the study.

Exclusion Criteria:

* If data available for patients is not adequate to make any treatment decisions they will be excluded. Non-consenting patients will be excluded.

Primary outcomes:
measure: PROSAIC-DS as a triage tool
timeFrame: 6-9 months
measure: PROSAIC-DS influence on MDTM concordance with approved guidelines
timeFrame: 6-9 months
Secondary outcomes:
measure: Cost effectiveness of PROSAIC-DS
timeFrame: 6-9 months - duration of data collection
measure: Qualitative Analysis: Patient acceptability
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas Hospitals
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Guys and St Thomas NHS Foundation Trust
name: Danny Ruta, MBBS MSc
role: PRINCIPAL_INVESTIGATOR
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