Clinical utility and cost-modelling of the PHI test to triage referrals into UK image based diagnostic services for suspected prostate cancer: The PRIM (Phi to RefIne Mri) multi-centre study
BAUS ePoster online library. Boxall N. 11/10/20; 304113; P9-3 Disclosure(s): This work was supported by an Addenbrookes Charitable Trust Innovation Grant and an unrestricted education grant for reagents from Beckman Coulter. Neither body had any influence or role in study design, execution, analysis, manuscript drafting, or reporting. Infrastructure funding is acknowledged from CRUK Cambridge Cancer Centre and the Cambridge Biomedical Campus.
Nicholas Boxall
Nicholas Boxall
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Clinical utility and cost-modelling of the PHI test to triage referrals into UK image based diagnostic services for suspected prostate cancer: The PRIM (Phi to RefIne Mri) multi-centre study

Gnanapragasam V1, Boxall N2, George A2, Archer P3, Aning J4, McCracken S5, Page T6, Starling L2, Kim L1
1University of Cambridge, United Kingdom, 2Cambridge University Hospitals NHS Trust, 3Southend Hospital, 4North Bristol NHS Trust, 5Sunderland Royal Infirmary, 6Newcastle upon Tyne NHS Trust,

Introduction:
MRI is a crucial part of the diagnostic pathway for prostate cancer but remains a resource intensive test. Here we tested the use of the PHI assay to refine the use of mpMRI and biopsies.

Methods:
Multicentre UK study where men due for mpMRI and biopsies had PHI and PSA tested at referral. AUC and diagnostic test statistics were calculated for overall and significant cancers (≥GG2).

Results:
554 men from 5 centres were recruited (median age, PSA and PHI - 66y, 8.0 ng/ml and 43.7 respectively). Overall and ≥GG2 cancer detection rates were 359/554 (65%) and 48% (266/554) respectively. There were no between-centre differences for demographics or cancer detection. AUC for ≥GG2 cancers was 0.63 for mpMRI, 0.70 for PSA and 0.82 for PHI. Amongst mpMRI negative men the AUCs were 0.70. 0.79 and 0.82 for PSA, PSA density and PHI respectively. Pre-referral PHI cut-offs between 20-30 had NPVs of 0.85-0.90 for ≥GG2 cancers. Using a PHI ≥30 cut-off to rule out referrals would reduce mpMRI by 25% and biopsies by 40%, missing 8% of ≥GG2. In contrast a mpMRI in all men and biopsy positive lesions reduced biopsies by 35% but missed 9% of ≥GG2 disease. Mean costs were lowest under a PHI strategy compared to all other options (including PSAd), and decision curve analysis demonstrated net clinical benefit.

Conclusion:
These data suggest that PHI test as a triaging test may be an effective way to refine use of imaging and reduce costs without compromising cancer detection rates.
Clinical utility and cost-modelling of the PHI test to triage referrals into UK image based diagnostic services for suspected prostate cancer: The PRIM (Phi to RefIne Mri) multi-centre study

Gnanapragasam V1, Boxall N2, George A2, Archer P3, Aning J4, McCracken S5, Page T6, Starling L2, Kim L1
1University of Cambridge, United Kingdom, 2Cambridge University Hospitals NHS Trust, 3Southend Hospital, 4North Bristol NHS Trust, 5Sunderland Royal Infirmary, 6Newcastle upon Tyne NHS Trust,

Introduction:
MRI is a crucial part of the diagnostic pathway for prostate cancer but remains a resource intensive test. Here we tested the use of the PHI assay to refine the use of mpMRI and biopsies.

Methods:
Multicentre UK study where men due for mpMRI and biopsies had PHI and PSA tested at referral. AUC and diagnostic test statistics were calculated for overall and significant cancers (≥GG2).

Results:
554 men from 5 centres were recruited (median age, PSA and PHI - 66y, 8.0 ng/ml and 43.7 respectively). Overall and ≥GG2 cancer detection rates were 359/554 (65%) and 48% (266/554) respectively. There were no between-centre differences for demographics or cancer detection. AUC for ≥GG2 cancers was 0.63 for mpMRI, 0.70 for PSA and 0.82 for PHI. Amongst mpMRI negative men the AUCs were 0.70. 0.79 and 0.82 for PSA, PSA density and PHI respectively. Pre-referral PHI cut-offs between 20-30 had NPVs of 0.85-0.90 for ≥GG2 cancers. Using a PHI ≥30 cut-off to rule out referrals would reduce mpMRI by 25% and biopsies by 40%, missing 8% of ≥GG2. In contrast a mpMRI in all men and biopsy positive lesions reduced biopsies by 35% but missed 9% of ≥GG2 disease. Mean costs were lowest under a PHI strategy compared to all other options (including PSAd), and decision curve analysis demonstrated net clinical benefit.

Conclusion:
These data suggest that PHI test as a triaging test may be an effective way to refine use of imaging and reduce costs without compromising cancer detection rates.
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