PROSAIC-DS Study (PROState AI in Cancer - Decision Support) (PROSAIC-DS)

April 27, 2022 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

I

Study Type

Interventional

Enrollment (Anticipated)

1040

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A: Visible to MDTM
Patients going through this arm have the decision support tool outcome visible to the MDTM
Other: Clinical decision support tool recommended outcome
The PROSAIC-DS tool will take the variables and produce a suggested outcome. It will supply supporting evidence and best practice for its recommendations
Other: Arm B: Not-visible to MDTM
Patients going through this arm will not have the decision support tool outcome visible to the MDTM
Other: Clinical decision support tool recommended outcome
The PROSAIC-DS tool will take the variables and produce a suggested outcome. It will supply supporting evidence and best practice for its recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROSAIC-DS as a triage tool
Time Frame: 6-9 months
The % of patients the PROSAIC-DS tool can appropriately triage away non-complex Prostate Cancer cases from the MDTM with appropriate treatment plans as directed by approved guidelines (EAU, BAUS, NICE, AUA).
6-9 months
PROSAIC-DS influence on MDTM concordance with approved guidelines
Time Frame: 6-9 months
Evaluation of PROSAIC-DS as a member of the MDTM via the impact of live PROSAIC-DS recommendations on MDTM decision concordance with approved guidelines (EAU, BAUS, NICE, AUA) on randomised patients discussed in the MDTM. This is measured through the difference in level of concordance between the MDTM with PROSAIC-DS switched off and the MDTM with PROSAIC-DS on when less complex cases (ones triaged away) are excluded.
6-9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness of PROSAIC-DS
Time Frame: 6-9 months - duration of data collection
Estimate the financial savings that PROSAIC-DS brings by triaging non-complex cases away from the MDTM.
6-9 months - duration of data collection
Qualitative Analysis: Patient acceptability
Time Frame: 12 months
We will use qualitative methods, and data capture methods including self-administered questionnaires, focus groups, semi-structured interviews and video analysis, to explore patient and staff views about, including concerns and satisfaction with, the use of AI technology to support clinical decisions in prostate cancer, both prior to their engagement with PROSAIC-DS, during and after deployment of the tool of the technology to patients.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London
King's College Hospital NHS Trust
Somerset NHS Foundation Trust
Deontics Limited
Prostate Cancer UK

Investigators

  • Principal Investigator: Danny Ruta, MBBS MSc, Guys and St Thomas NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 304825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Clinical decision support tool recommended outcome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe