Low Baseline IsoPSA Index is Associated With a Prolonged Low Risk of Clinically Significant Prostate Cancer Diagnosis in Men With an Elevated PSA - 30/01/25

Doi : 10.1016/j.urology.2025.01.019

Nour Abdallah ^a,^⁎,^{^{1
Nour Abdallah and Rebecca A. Campbell contributed equally.}} , Rebecca A. Campbell ^a,^{^{1
Nour Abdallah and Rebecca A. Campbell contributed equally.}}, Tarik Benidir ^a, Andrew Wood ^a, Zaeem Lone ^b, Ao Zhang ^a, Onuralp Ergun ^c, Caleb Curry ^a, Patrick Michael ^a, Ross Liao ^a, Jaya Sai Chavali ^a, Alberto Pieretti ^d, Jesse McKenney ^e, Andrei Purysko ^f, Samuel Haywood ^a, Zeyad Schwen ^a, Ruben Olivares ^a, Jihad Kaouk ^a, Robert Abouassaly ^a, Eric A. Klein ^a, Christopher J. Weight ^a
^a Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH
^b Cleveland Clinic Lerner College of Medicine, Cleveland, OH
^c Department of Urology, University of Minnesota, Minneapolis, MN
^d Department of Urology, Cleveland Clinic Florida, Weston, FL
^e Department of Pathology, Cleveland Clinic, Cleveland, OH
^f Abdominal Imaging Section and Nuclear Radiology Department, Imaging Institute, Cleveland Clinic, Cleveland, OH

^⁎Address correspondence to: Nour Abdallah, MD, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH, 44195.Cleveland Clinic Foundation9500 Euclid AveClevelandOH44195

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Thursday 30 January 2025
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Resumen

Objective

To compare the rate of diagnosing clinically significant prostate cancer (csPCa) in men with elevated prostate-specific antigen (PSA) stratified by baseline IsoPSA Index, thus assessing IsoPSA’s intermediate-term predictive ability for csPCa.

Material and methods

Single-center retrospective review of consecutive patients (n = 1578) who underwent IsoPSA testing from November 2016-August 2022. Data dichotomized into patients with low (≤6) and high IsoPSA Indices (>6). Most recent subsequent IsoPSA and PSA tests, prostate biopsy, and magnetic resonance imaging (MRI) collected. Time-to-event Kaplan-Meier estimates generated for the risk of csPCa stratified by baseline IsoPSA Index.

Results

Among 541 patients with initial low IsoPSA Indices (≤6), 23 (4.3%) were diagnosed with csPCa on a subsequent biopsy. Also, among these 541 patients, 204 had an MRI, of which 48/204 (23.5%) showed suspicious lesions (PIRADS ≥4). Among 1037 patients with initial high IsoPSA Indices, 366 (35.3%) were diagnosed with csPCa on a subsequent biopsy. Also, among these 1037 patients, 712 had an MRI, of which 342/712 (48.0%) showed suspicious lesions (PIRADS ≥4). After 12, 24, and 30 months, respectively, the risk of developing csPCa was 0.4% (95% CI 0.1%-1.6%), 2.5% (1.4%-4.4%), and 6.3% (4%-9.6%) in patients with low IsoPSA Indices, compared to 5.9% (4.6%-7.6%), 31.7% (28.3%-35.4%), and 49.5% (45.3%-53.9%) in patients with high IsoPSA Indices. Limitations include the retrospective review of prospectively collected data and unknown true csPCa rates as not all patients were biopsied.

Conclusion

The risk of developing csPCa was smaller in patients with initial low vs high IsoPSA Indices over the ensuing 30 months, which supports using IsoPSA to safely avoid follow-up testing.

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