Effect of Bacillus Calmette-Guerin Exposure on Prostate Cancer Detection Using Magnetic Resonance Imaging: A Cohort Study.

Background: Granulomatous prostatitis is a medical condition that may mimic prostate cancer.

Purpose: Granulomatous prostatitis resulting from BCG-exposure can confound the diagnosis of prostate cancer based on prostate imaging and data system (PI-RADS) classification observed on multiparametric prostate magnetic resonance imaging (mpMRI).

Study Type, Population, Assessment And Statistical Tests: A cohort study was conducted, enrolling consecutive males at risk for prostate cancer who underwent an mpMRI-targeted prostate biopsy between February 2016 and August 2023. The focus of the study was on prior BCG-exposure as adjuvant treatment for non-muscle-invasive urothelial carcinoma within the 3 years prior the magnetic resonance imaging (MRI). Exclusion criteria were a prior androgen deprivation therapy, prostate surgery or radiation, and BCG-exposure occurring more than 3 years and less than 3 months before the MRI. Chi-square, logistic-regression, statistical association, and homogeneity tests were used.

Results: Total 712 patients, 899 biopsied lesions (218 PI-RADS 3, 521 PI-RADS 4 and 160 PI-RADS 5) and 20 patients with 30 lesions within the BCG-exposed cohort. Chi-square and logistic-regression tests showed an association between PI-RADS with malignancy and significant tumor (ST), considering PI-RADS3 as the reference (OR: 4.9 [95% CI, 3.4-7.1] for PI-RADS4 and OR: 21.7 [95% CI, 12.4-37.8] for PI-RADS5 for malignancy, and OR: 5.3 [95% CI, 3.2-8.7] for PI-RADS4 and OR: 16.5 [95% CI, 9.4-28.9] for PI-RADS5 regarding ST). A statistically significant negative association was demonstrated between malignancy and ST with respect to BCG-exposure (OR: 0.15 [95% CI, 0.06-0.39] and OR: 0.39 [95% CI, 0.15-1.0], respectively). Statistically significant risk-difference for malignancy in patients nonexposed to BCG regarding those exposed was 45% (61.6% vs. 16.7%) for PI-RADS4, and 68.5% (90.7% vs. 22.2%) and 42.7% (64.9% vs. 22.2%) concerning malignancy and ST for PI-RADS5, respectively.

Data Conclusions: Granulomatous prostate reaction caused by BCG-exposure acts as confounding factor for prostate MRI interpretation. The risk of malignancy and significant tumor on targeted biopsy to PI-RADS 3, 4 and 5 is notably lower in exposed patients.