Prostate CancerPROSAIC-DSNCT05355727
PROSAIC-DS Study (PROState AI in Cancer - Decision Support)
A study testing Clinical decision support tool recommended outcome in people with Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Clinical decision support tool recommended outcome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- If data available for patients is not adequate to make any treatment decisions they will be excluded. Non-consenting patients will be excluded.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guys and St Thomas Hospitals
London, SE1 9RT
Danny Ruta, MBBS MSc, +44 (0)7969917016, Danny.Ruta@gstt.nhs.uk
Kings College Hospital
London, SE5 9RS
Jonathan Makanjuola, MBBS BSc, +447939512119, jonathan.makanjuola@nhs.net
About this study
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
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.
Read more
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.
Read the detailed description
I
- Conditions
- Prostate Cancer
- Being tested
- Clinical decision support tool recommended outcome
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support tool recommended outcomeOther
The PROSAIC-DS tool will take the variables and produce a suggested outcome. It will supply supporting evidence and best practice for its recommendations
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Visible to MDTM | Other | Patients going through this arm have the decision support tool outcome visible to the MDTM Receives: Other: Clinical decision support tool recommended outcome |
| Arm B: Not-visible to MDTM | Other | Patients going through this arm will not have the decision support tool outcome visible to the MDTM Receives: Other: Clinical decision support tool recommended outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROSAIC-DS as a triage tool
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).
Measured: 6-9 months
PROSAIC-DS influence on MDTM concordance with approved guidelines
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.
Measured: 6-9 months
Secondary outcomes (2)
Cost effectiveness of PROSAIC-DS
Estimate the financial savings that PROSAIC-DS brings by triaging non-complex cases away from the MDTM.
Measured: 6-9 months - duration of data collection
Qualitative Analysis: Patient acceptability
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, King's College London, Deontics Limited, Somerset NHS Foundation Trust, Prostate Cancer UK
- Responsible party
- Sponsor
- Investigators
- Danny Ruta, MBBS MSc, Principal investigator, Guys and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355727
- Sponsor's protocol ID
- 304825
- Acronym
- PROSAIC-DS
- Status last verified
- Apr 2022
- First submitted
- 16 Feb 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knight SR, Cao KN, South M, Hayward N, Hunter JP, Fox J. Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines. Transplantation. 2018 Oct;102(10):e447-e453. doi: 10.1097/TP.0000000000002374.
PubMed 30028418Taylor C, Atkins L, Richardson A, Tarrant R, Ramirez AJ. Measuring the quality of MDT working: an observational approach. BMC Cancer. 2012 May 29;12:202. doi: 10.1186/1471-2407-12-202.
PubMed 22642614Munro AJ. Multidisciplinary Team Meetings in Cancer Care: An Idea Whose Time has Gone? Clin Oncol (R Coll Radiol). 2015 Dec;27(12):728-31. doi: 10.1016/j.clon.2015.08.008. Epub 2015 Sep 11. No abstract available.
PubMed 26365047Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Cancer multidisciplinary team meetings: evidence, challenges, and the role of clinical decision support technology. Int J Breast Cancer. 2011;2011:831605. doi: 10.4061/2011/831605. Epub 2011 Jul 17.
PubMed 22295234Miles A, Chronakis I, Fox J, Mayer A. Use of a computerised decision aid (DA) to inform the decision process on adjuvant chemotherapy in patients with stage II colorectal cancer: development and preliminary evaluation. BMJ Open. 2017 Mar 24;7(3):e012935. doi: 10.1136/bmjopen-2016-012935.
PubMed 28341685Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance. BMJ Open. 2012 Jun 25;2(3):e000439. doi: 10.1136/bmjopen-2011-000439. Print 2012.
PubMed 22734113Patkar V, Hurt C, Steele R, Love S, Purushotham A, Williams M, Thomson R, Fox J. Evidence-based guidelines and decision support services: A discussion and evaluation in triple assessment of suspected breast cancer. Br J Cancer. 2006 Dec 4;95(11):1490-6. doi: 10.1038/sj.bjc.6603470. Epub 2006 Nov 21.
PubMed 17117181Peleg M, Fox J, Patkar V, Glasspool D, Chronakis I, South M, Nassar S, Gaglia JL, Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Garber JR. A Computer-Interpretable Version of the AACE, AME, ETA Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules. Endocr Pract. 2014 Apr;20(4):352-9. doi: 10.4158/EP13271.OR.
PubMed 24246343Bury J, Hurt C, Roy A, Cheesman L, Bradburn M, Cross S, Fox J, Saha V. LISA: a web-based decision-support system for trial management of childhood acute lymphoblastic leukaemia. Br J Haematol. 2005 Jun;129(6):746-54. doi: 10.1111/j.1365-2141.2005.05541.x.
PubMed 15953000Tural C, Ruiz L, Holtzer C, Schapiro J, Viciana P, Gonzalez J, Domingo P, Boucher C, Rey-Joly C, Clotet B; Havana Study Group. Clinical utility of HIV-1 genotyping and expert advice: the Havana trial. AIDS. 2002 Jan 25;16(2):209-18. doi: 10.1097/00002030-200201250-00010.
PubMed 11807305Walton RT, Gierl C, Yudkin P, Mistry H, Vessey MP, Fox J. Evaluation of computer support for prescribing (CAPSULE) using simulated cases. BMJ. 1997 Sep 27;315(7111):791-5. doi: 10.1136/bmj.315.7111.791.
PubMed 9345174Patkar V, Fox J. Clinical guidelines and care pathways: a case study applying PROforma decision support technology to the breast cancer care pathway. Stud Health Technol Inform. 2008;139:233-42.
PubMed 18806332
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05355727
- Acronym / sponsor ID
- PROSAIC-DS / 304825
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, King's College London, Deontics Limited, Somerset NHS Foundation Trust, Prostate Cancer UK
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Visible to MDTM | Other | Other: Clinical decision support tool recommended outcomePatients going through this arm have the decision support tool outcome visible to the MDTM |
| Arm B: Not-visible to MDTM | Other | Other: Clinical decision support tool recommended outcomePatients going through this arm will not have the decision support tool outcome visible to the MDTM |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- If data available for patients is not adequate to make any treatment decisions they will be excluded. Non-consenting patients will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision support tool recommended outcomeThe 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 A: Visible to MDTM, Arm B: Not-visible to MDTM |
Primary outcome
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).
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.
2 secondary outcomes
Cost effectiveness of PROSAIC-DS
Time frame: 6-9 months - duration of data collection
Qualitative Analysis: Patient acceptability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 30028418Knight SR, Cao KN, South M, Hayward N, Hunter JP, Fox J. Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines. Transplantation. 2018 Oct;102(10):e447-e453. doi: 10.1097/TP.0000000000002374.
- Background: PubMed 22642614Taylor C, Atkins L, Richardson A, Tarrant R, Ramirez AJ. Measuring the quality of MDT working: an observational approach. BMC Cancer. 2012 May 29;12:202. doi: 10.1186/1471-2407-12-202.
- Background: PubMed 26365047Munro AJ. Multidisciplinary Team Meetings in Cancer Care: An Idea Whose Time has Gone? Clin Oncol (R Coll Radiol). 2015 Dec;27(12):728-31. doi: 10.1016/j.clon.2015.08.008. Epub 2015 Sep 11. No abstract available.
- Background: PubMed 22295234Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Cancer multidisciplinary team meetings: evidence, challenges, and the role of clinical decision support technology. Int J Breast Cancer. 2011;2011:831605. doi: 10.4061/2011/831605. Epub 2011 Jul 17.
- Background: PubMed 28341685Miles A, Chronakis I, Fox J, Mayer A. Use of a computerised decision aid (DA) to inform the decision process on adjuvant chemotherapy in patients with stage II colorectal cancer: development and preliminary evaluation. BMJ Open. 2017 Mar 24;7(3):e012935. doi: 10.1136/bmjopen-2016-012935.
- Background: PubMed 22734113Patkar V, Acosta D, Davidson T, Jones A, Fox J, Keshtgar M. Using computerised decision support to improve compliance of cancer multidisciplinary meetings with evidence-based guidance. BMJ Open. 2012 Jun 25;2(3):e000439. doi: 10.1136/bmjopen-2011-000439. Print 2012.
- Background: PubMed 17117181Patkar V, Hurt C, Steele R, Love S, Purushotham A, Williams M, Thomson R, Fox J. Evidence-based guidelines and decision support services: A discussion and evaluation in triple assessment of suspected breast cancer. Br J Cancer. 2006 Dec 4;95(11):1490-6. doi: 10.1038/sj.bjc.6603470. Epub 2006 Nov 21.
- Background: PubMed 24246343Peleg M, Fox J, Patkar V, Glasspool D, Chronakis I, South M, Nassar S, Gaglia JL, Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedus L, Garber JR. A Computer-Interpretable Version of the AACE, AME, ETA Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules. Endocr Pract. 2014 Apr;20(4):352-9. doi: 10.4158/EP13271.OR.
- Background: PubMed 15953000Bury J, Hurt C, Roy A, Cheesman L, Bradburn M, Cross S, Fox J, Saha V. LISA: a web-based decision-support system for trial management of childhood acute lymphoblastic leukaemia. Br J Haematol. 2005 Jun;129(6):746-54. doi: 10.1111/j.1365-2141.2005.05541.x.
- Background: PubMed 11807305Tural C, Ruiz L, Holtzer C, Schapiro J, Viciana P, Gonzalez J, Domingo P, Boucher C, Rey-Joly C, Clotet B; Havana Study Group. Clinical utility of HIV-1 genotyping and expert advice: the Havana trial. AIDS. 2002 Jan 25;16(2):209-18. doi: 10.1097/00002030-200201250-00010.
- Background: PubMed 9345174Walton RT, Gierl C, Yudkin P, Mistry H, Vessey MP, Fox J. Evaluation of computer support for prescribing (CAPSULE) using simulated cases. BMJ. 1997 Sep 27;315(7111):791-5. doi: 10.1136/bmj.315.7111.791.
- Background: PubMed 18806332Patkar V, Fox J. Clinical guidelines and care pathways: a case study applying PROforma decision support technology to the breast cancer care pathway. Stud Health Technol Inform. 2008;139:233-42.
- Meeting Patients Needs: Improving the effectiveness of Multidisciplinary Team Meetings in Cancer Services. 2018Link provided by the sponsor.
- Transforming Multidisciplinary Team Meetings (MDTMs): Report by Prof Martin Gore (2017) for NHS EnglandLink provided by the sponsor.
- NHS England : Streamlining Multi-Disciplinary Team MeetingsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Ruta, MBBS MSc principal investigator
Guys and St Thomas NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support tool recommended outcome in people with Prostate Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Ruta, MBBS MSc (+44 (0)7969917016, Danny.Ruta@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROSAIC-DS as a triage tool (time frame: 6-9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355727, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.