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Validation of a Digital Pathology–Based Multimodal Artificial Intelligence Biomarker in a Prospective, Real-World Prostate Cancer Cohort Treated with Prostatectomy

Bjartell, Anders LU ; Krzyzanowska, Agnieszka LU ; Liu, Vinnie Y.T. ; Tierney, Meghan ; Royce, Trevor J. ; Sjöström, Martin LU ; Palominos-Rivera, Marisol Macarena LU ; Chen, Emmalyn ; Kraft, Alexandra and Esteva, Andre , et al. (2025) In Clinical Cancer Research 31(8). p.1546-1553
Abstract

Purpose: A multimodal artificial intelligence (MMAI) biomarker was developed using clinical trial data from North American men with localized prostate cancer treated with definitive radiation, using biopsy digital pathology images and key clinical information (age, PSA, and T-stage) to generate prognostic scores. This study externally validates the biomarker in a prospective, real-world dataset of men who underwent radical prostatectomy (RP) for localized prostate cancer at a tertiary referral center in Sweden. Experimental Design: Association between the MMAI scores (continuous and categorical) and endpoints of interest was assessed with Fine–Gray and cumulative incidence analyses for biochemical recurrence (BCR) and logistic... (More)

Purpose: A multimodal artificial intelligence (MMAI) biomarker was developed using clinical trial data from North American men with localized prostate cancer treated with definitive radiation, using biopsy digital pathology images and key clinical information (age, PSA, and T-stage) to generate prognostic scores. This study externally validates the biomarker in a prospective, real-world dataset of men who underwent radical prostatectomy (RP) for localized prostate cancer at a tertiary referral center in Sweden. Experimental Design: Association between the MMAI scores (continuous and categorical) and endpoints of interest was assessed with Fine–Gray and cumulative incidence analyses for biochemical recurrence (BCR) and logistic regression for adverse pathology (AP) at RP. Results: The analysis included 143 patients with evaluable biopsy pathology images and complete clinical data to generate MMAI scores. The median follow-up was 8.8 years. At diagnosis, the median PSA was 7.5 ng/mL, the median age was 64 years, 29% had a Gleason grade group ≥3, and 88 men were evaluable for AP at RP. MMAI was significantly associated with BCR [subdistribution HR, 2.45; 95% confidence interval (CI), 1.77–3.38; P < 0.001] and AP at RP (OR, 4.85; 95% CI, 2.54–10.78; P < 0.001). Estimated 5-year BCR rates for MMAI intermediate to high versus low were 25% (95% CI, 16%–36%) versus 4% (95% CI, 1%–11%), respectively. Conclusions: The MMAI biomarker, previously shown to be prognostic for distant metastasis and prostate cancer–specific mortality in men receiving definitive radiation, was prognostic for post-RP endpoints: BCR and AP. This biomarker validation study further supports the use of MMAI biomarkers in men with prostate cancer outside North America and those treated with RP.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical Cancer Research
volume
31
issue
8
pages
8 pages
publisher
American Association for Cancer Research Inc.
external identifiers
  • scopus:105003609852
  • pmid:39983011
ISSN
1078-0432
DOI
10.1158/1078-0432.CCR-24-3656
language
English
LU publication?
yes
additional info
Publisher Copyright: ©2025 The Authors; Published by the American Association for Cancer Research.
id
1c5f583d-2a0c-4abc-9d93-6d1390704741
date added to LUP
2025-08-06 14:57:37
date last changed
2025-08-07 03:00:02
@article{1c5f583d-2a0c-4abc-9d93-6d1390704741,
  abstract     = {{<p>Purpose: A multimodal artificial intelligence (MMAI) biomarker was developed using clinical trial data from North American men with localized prostate cancer treated with definitive radiation, using biopsy digital pathology images and key clinical information (age, PSA, and T-stage) to generate prognostic scores. This study externally validates the biomarker in a prospective, real-world dataset of men who underwent radical prostatectomy (RP) for localized prostate cancer at a tertiary referral center in Sweden. Experimental Design: Association between the MMAI scores (continuous and categorical) and endpoints of interest was assessed with Fine–Gray and cumulative incidence analyses for biochemical recurrence (BCR) and logistic regression for adverse pathology (AP) at RP. Results: The analysis included 143 patients with evaluable biopsy pathology images and complete clinical data to generate MMAI scores. The median follow-up was 8.8 years. At diagnosis, the median PSA was 7.5 ng/mL, the median age was 64 years, 29% had a Gleason grade group ≥3, and 88 men were evaluable for AP at RP. MMAI was significantly associated with BCR [subdistribution HR, 2.45; 95% confidence interval (CI), 1.77–3.38; P &lt; 0.001] and AP at RP (OR, 4.85; 95% CI, 2.54–10.78; P &lt; 0.001). Estimated 5-year BCR rates for MMAI intermediate to high versus low were 25% (95% CI, 16%–36%) versus 4% (95% CI, 1%–11%), respectively. Conclusions: The MMAI biomarker, previously shown to be prognostic for distant metastasis and prostate cancer–specific mortality in men receiving definitive radiation, was prognostic for post-RP endpoints: BCR and AP. This biomarker validation study further supports the use of MMAI biomarkers in men with prostate cancer outside North America and those treated with RP.</p>}},
  author       = {{Bjartell, Anders and Krzyzanowska, Agnieszka and Liu, Vinnie Y.T. and Tierney, Meghan and Royce, Trevor J. and Sjöström, Martin and Palominos-Rivera, Marisol Macarena and Chen, Emmalyn and Kraft, Alexandra and Esteva, Andre and Feng, Felix Y.}},
  issn         = {{1078-0432}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{8}},
  pages        = {{1546--1553}},
  publisher    = {{American Association for Cancer Research Inc.}},
  series       = {{Clinical Cancer Research}},
  title        = {{Validation of a Digital Pathology–Based Multimodal Artificial Intelligence Biomarker in a Prospective, Real-World Prostate Cancer Cohort Treated with Prostatectomy}},
  url          = {{http://dx.doi.org/10.1158/1078-0432.CCR-24-3656}},
  doi          = {{10.1158/1078-0432.CCR-24-3656}},
  volume       = {{31}},
  year         = {{2025}},
}