Prostate cancer is one of the most frequently diagnosed malignancies among men and a major contributor to global cancer-related morbidity and mortality. It is the second most commonly diagnosed cancer in men worldwide and remains one of the leading causes of cancer death [1]. The global age-standardized incidence has been estimated at approximately 30 cases per 100,000 men, with substantial geographic variation attributable to differences in screening, lifestyle, healthcare access, and population aging [2]. In India, the true burden is uncertain because of limited population-based registries and underreporting, yet available estimates suggest a rising trend, with regional variation in age-adjusted incidence across metropolitan and non-metropolitan regions [3].

The etiology of prostate cancer is multifactorial. Age is the most important risk factor, the disease being rare before 40 years and increasing markedly thereafter; family history and germline mutations such as BRCA1 and BRCA2 further increase susceptibility [4]. Lifestyle and metabolic factors, including diet, obesity, smoking, and diabetes, are also implicated, and the interaction of genetic predisposition with environmental exposures is thought to drive pathogenesis [5]. Histologically, most prostate cancers are adenocarcinomas arising from glandular epithelium, often preceded by high-grade prostatic intraepithelial neoplasia; the biological behavior is heterogeneous, ranging from indolent to aggressive disease [6]. The Gleason grading system, refined into Grade Groups, remains a central prognostic determinant and guides treatment decisions [7].

Because prostate cancer spans a wide spectrum of clinical behavior, modern diagnostic strategies aim to identify clinically significant cancer (csPCa) while avoiding overdiagnosis and overtreatment of indolent tumors [8]. Advanced imaging is increasingly used to distinguish significant from insignificant disease and to guide targeted biopsy [9]. Most prostate cancers arise in the peripheral zone (PZ), which contains the majority of glandular tissue and accounts for roughly 70–75% of cases [10]. The transition zone (TZ), commonly involved by benign prostatic hyperplasia (BPH), accounts for about 20–25% of cancers and poses greater diagnostic difficulty [11], while a smaller proportion arise in the central zone and may show aggressive behavior with seminal vesicle invasion [12].

Traditional evaluation of suspected prostate cancer begins with serum PSA and DRE. PSA is a glycoprotein produced by prostatic epithelium and is a sensitive but poorly specific biomarker, as levels also rise in prostatitis and BPH [13]; reported specificity ranges widely [14]. DRE detects palpable abnormalities but has low sensitivity and is operator-dependent, with a pooled sensitivity of approximately 28.6% for prostate cancer detection in symptomatic men [15]. Patients with abnormal PSA or DRE typically undergo systematic

TRUS-guided biopsy, which samples the gland in a non-targeted manner and may miss up to 30% of cancers, particularly anterior tumors, while also underestimating tumor grade and carrying procedural risks [16]. Concern about the harms of overdiagnosis and overtreatment led the U.S. Preventive Services Task Force to recommend against routine PSA-based screening in 2012 [17].

Magnetic resonance imaging (MRI) has emerged as a valuable tool for prostate evaluation owing to superior soft-tissue contrast and multiplanar capability, evolving from a purely staging modality to a comprehensive technique for detection, localization, biopsy guidance, and risk stratification [18]. Multiparametric MRI (mpMRI) combines anatomical and functional sequences to provide a comprehensive assessment of prostate tissue [19]. T2WI provides detailed zonal anatomy, on which the normal PZ appears hyperintense and cancer typically appears as a focal hypointense lesion [21]; DCE evaluates tumor vascularity, with malignant lesions showing early enhancement and washout due to angiogenesis [20]. DWI evaluates water molecule motion, and malignant lesions—having increased cellular density—show restricted diffusion, appearing hyperintense on high b-value images and hypointense on ADC maps [22]. The integration of these sequences substantially improves detection and localization of csPCa compared with any single sequence, and enables MRI- targeted biopsy [23]. mpMRI-based suspicion assessment improves the detection of significant cancer while reducing unnecessary biopsies [24], and the PROMIS study demonstrated that mpMRI can improve significant-cancer detection while reducing overdiagnosis of insignificant disease [25].

To standardize acquisition, interpretation, and reporting, the Prostate Imaging Reporting and Data System (PI-RADS) was developed by international radiological societies, providing a structured five-point score reflecting the likelihood of csPCa [26]. PI-RADS version 2 introduced the concept of a dominant sequence (DWI for the PZ and T2WI for the TZ, with DCE upgrading equivocal PI-RADS 3 lesions) [27], and version 2.1 further refined the interpretation criteria and technical recommendations to improve interobserver agreement [28]. Despite these advances, widespread implementation of mpMRI is limited by cost, restricted availability of advanced facilities, and the need for specialized expertise, particularly in low- and middle-income settings [29]. Nevertheless, accumulating evidence supports an “MRI-first” pre-biopsy pathway that improves lesion characterization and staging accuracy [30].

Against this background, the present study was undertaken to evaluate the effectiveness of mpMRI, interpreted with the PI-RADS scoring system, in detecting prostate malignancy among patients with suspected prostate cancer. The specific objectives were to establish the role of MRI in early detection while addressing the limitations of PSA and TRUS biopsy, to identify clinically significant cancers while avoiding overdiagnosis of indolent disease, to explore the applicability of PI-RADS as a standardized reporting system, and to assess the association between mpMRI features and histopathological outcomes.

Study design and setting

This was a prospective observational study conducted in the Department of Radio- diagnosis, Bangalore Medical College and Research Institute (BMCRI), Bengaluru, from March 2024 to September 2025. Patients who presented to the Surgery and Urology outpatient departments of hospitals attached to BMCRI with features indicating the need for prostate cancer screening were considered for inclusion. Institutional Ethics Committee approval was obtained, and written informed consent was taken from all participants before enrolment.

Participants

Men aged 40–70 years with clinical features suggestive of a prostate mass or lower urinary tract symptoms (voiding or obstructive complaints, irritative urinary symptoms, or hematuria) were eligible. Additional inclusion criteria were persistent PSA elevation ≥4.0 ng/mL and having a first-degree relative with prostate cancer. Patients were excluded if they had benign prostatic conditions such as prostatitis or benign prostatic hypertrophy with only transient PSA elevation >4.0 ng/mL, or general contraindications to MRI, including metallic implants, pacemaker implants, or claustrophobia. Relevant demographic data and medical history, including obstructive urinary symptoms, were recorded, and baseline investigations included abdominal sonography and serum PSA.

Sample size

The sample size was estimated using nMaster software version 2.0, based on the diagnostic performance reported by Ahmed et al. (2022), assuming a sensitivity of 81.8% for T2W MRI and 84.6% for DWI/ADC [31]. With an alpha of 0.05 and a precision of 14%, a sample size of 27 subjects was calculated; after adding a 10% allowance for attrition, a total of 30 patients were enrolled.

Imaging technique / protocol

All MRI studies were performed with patients in the supine position on a United Imaging uMR 570 1.5-Tesla scanner using a 16-channel pelvic phased-array coil. Bowel motion artifact was minimized with an antispasmodic agent (hyoscine butyl bromide); patients fasted for four hours, were advised bowel evacuation before the examination, and were counselled regarding abstinence from ejaculation. The mpMRI protocol comprised: axial T1-weighted imaging to evaluate prostatic hemorrhage, pelvic bone and soft-tissue characterization, and lymph nodes; T2-weighted imaging in axial, sagittal, and coronal planes to assess glandular morphology, transition-zone evaluation, extra-prostatic extension (EPE), and seminal vesicle invasion (SVI); axial DWI with b-values of 50–100 and 800–1000 s/mm² for ADC calculation and high b-values ≥1400 s/mm²; axial DCE with contrast injected at 0.1 mmol/kg at 3 mL/s; and 3D T2-weighted imaging with isotropic resolution ≤0.7 mm. High b-value DWI was obtained for all lesions. Each suspicious lesion was assessed using the PI-RADS v2 scoring system on a five-point scale (1 = very low to 5 = very high probability of clinically significant cancer); PZ lesions were assessed primarily using DWI, TZ lesions using T2WI, and DCE was used in a supplementary role for PI-RADS 3 lesions. TRUS-guided biopsy provided the histopathological reference standard.

Statistical analysis

Statistical analysis was performed using SPSS version 25. Frequency analysis was used to describe categorical variables such as sex, MRI features, and lesion location. The chi-square test was used to assess associations between categorical variables, particularly between PI- RADS score and biopsy result; Fisher exact test was applied where cell counts were small. Descriptive statistics were reported as mean ± standard deviation (SD), median (interquartile range, IQR), and range for continuous variables such as age, PSA, and MRI parameters. A p- value <0.05 was considered statistically significant.All 30 enrolled patients completed mpMRI and subsequent TRUS-guided biopsy, and all were included in the analysis; there were no losses to follow-up.

This prospective observational study assessed the diagnostic performance of mpMRI using the PI-RADS scoring system in 30 male patients with suspected prostate cancer based on elevated PSA or abnormal DRE. All participants underwent mpMRI (T2WI, DWI, and DCE), with histopathological biopsy serving as the reference standard. The mean age of participants was 62.1 ± 6.9 years, with a median of 62 (IQR 57–67) years and a range of 48–74 years. The largest age group was 61–70 years (40.0%), followed by 51–60 years (30.0%). All participants were male (100%), and the mean serum PSA was 9.36 ± 2.98 ng/mL, with a median of 9.10 (IQR 7.20–11.30) ng/mL and a range of 4.30–16.80 ng/mL (Table 1).

Table 1. Baseline demographic and clinical characteristics of study participants (n = 30).

Table 2. Distribution of suspicious lesion location on MRI (n = 30).

Table 3. Distribution of PI-RADS scores on mpMRI (n = 30).

On mpMRI, most suspicious lesions were located in the peripheral zone (60.0%), followed by the transition zone (30.0%) and the central zone (10.0%) (Table 2). PI-RADS 3 was the most common category (33.3%), followed by PI-RADS 4 (30.0%), PI-RADS 2

(20.0%), and PI-RADS 5 (16.7%) (Table 3). Histopathology confirmed malignancy in 13 patients (43.3%), while 17 patients (56.7%) had benign pathology (Table 4).A statistically significant association was observed between PI-RADS category and biopsy result (p = 0.002). Malignancy was detected in 71.4% of patients with PI-RADS ≥4, compared with only 18.8% of patients with PI-RADS ≤3 (Table 5; Figure 3). A representative large clinically significant (PI-RADS 5) lesion showing restricted diffusion is shown in Figure 1.

• Axial T2-weighted image shows an enlarged prostate containing a bulky, heterogeneous, poorly circumscribed lesion. (B) High b-value diffusion-weighted image shows marked hyperintensity of the lesion, with (C) corresponding low signal on the ADC map, indicating restricted diffusion. The combined findings correspond to a PI-RADS category 5 lesion.

Table 4. Histopathological (biopsy) findings (n = 30).

Table 5. Association between PI-RADS category and biopsy result (chi-square test).

Table 6. Frequency of individual MRI features on mpMRI (n = 30).

Individual mpMRI features were distributed as follows: T2 hypointense lesions were present in 18 patients (60.0%), diffusion restriction on DWI in 17 patients (56.7%), low ADC values in 16 patients (53.3%), early enhancement on DCE in 15 patients (50.0%), extra- prostatic extension in 5 patients (16.7%), seminal vesicle invasion in 3 patients (10.0%), and pelvic lymph node enlargement in 4 patients (13.3%) (Table 6; Figure 4).

When individual MRI features were compared with histopathology, T2 hypointensity, diffusion restriction, low ADC value, and early DCE enhancement did not differ significantly between benign and malignant lesions (p = 0.214, 0.187, 0.241, and 0.316, respectively). In contrast, extra-prostatic extension, seminal vesicle invasion, and pelvic lymph node enlargement were each present only in malignant lesions and showed significant associations with malignancy (p = 0.028, 0.045, and 0.031, respectively; Table 7). A representative peripheral-zone tumour with capsular involvement is shown in Figure 2.

Figure 2. Multiparametric MRI of a biopsy-proven peripheral-zone prostate cancer. (A) Axial T2-weighted image shows an ill-defined, non-circumscribed hypointense lesion in the left peripheral zone. (B) High b-value diffusion-weighted image shows focal hyperintensity, with (C) corresponding low signal on the ADC map, indicating restricted diffusion. The lesion contacts and bulges the capsule, consistent with a PI-RADS category 5 lesion with suspected extraprostatic extension.

Figure 3. Malignancy rate on TRUS-guided biopsy stratified by PI-RADS category. Malignancy was confirmed in 71.4% of lesions scored PI-RADS ≥4 versus only 18.8% of lesions scored PI-RADS ≤3, a statistically significant difference (chi-square p = 0.002) (data from Table 5).

Figure 4. Frequency of individual multiparametric MRI features across the 30 participants, ranked from most to least common. Morphological and functional features (T2 hypointensity, diffusion restriction, low ADC value, early DCE enhancement) were present in roughly half the cohort, whereas advanced-disease markers (extra-prostatic extension, pelvic lymph node enlargement, seminal vesicle invasion) were infrequent (data from Table 6).

Evaluation of the diagnostic accuracy of individual MRI parameters showed that diffusion restriction on DWI had the highest sensitivity (57.9%), followed by T2 hypointense lesions and low ADC values (52.6% each), while early DCE enhancement had the lowest sensitivity (42.1%). The specificity of these functional and morphological parameters was relatively low (27.3–45.5%). Conversely, extra-prostatic extension, seminal vesicle invasion, and pelvic lymph node enlargement each demonstrated 100% specificity and 100% positive predictive value but low sensitivity (Table 8; Figure 5).

Figure 5. Sensitivity and specificity of individual mpMRI parameters for the detection of malignancy. The functional and morphological parameters (T2 hypointensity, diffusion restriction, low ADC value, early DCE enhancement) showed moderate sensitivity but low specificity, whereas extra-prostatic extension, seminal vesicle invasion, and pelvic lymph node enlargement each showed 100% specificity but low sensitivity (data from Table 8).

Table 7. MRI features versus histopathology (benign vs malignant) (n = 30).

Table 8. Diagnostic accuracy of individual MRI parameters for detection of malignancy.

Table 9. PI-RADS score versus histopathology (benign vs malignant) (n = 30); chi-square test.

Table 10. Diagnostic accuracy measures of mpMRI using PI-RADS ≥4 as a positive test.

Higher PI-RADS scores were more frequently associated with malignant histopathology. All PI-RADS 5 lesions were malignant (36.8% of malignant lesions), whereas PI-RADS 2 lesions were predominantly benign; intermediate scores (PI-RADS 3 and 4) showed mixed outcomes. Although malignancy increased with rising PI-RADS score, this ordinal association did not reach statistical significance (p = 0.089; Table 9).

Using PI-RADS ≥4 as the diagnostic threshold, mpMRI correctly identified 12 malignant and 7 benign cases, with 4 false positives and 7 false negatives. The overall diagnostic accuracy was 63.3%, with a sensitivity of 63.2%, specificity of 63.6%, positive predictive value of 75.0%, and negative predictive value of 50.0% (Table 10; Figure 6).

Figure 6. Overall diagnostic performance of mpMRI using PI-RADS ≥4 as the threshold for a positive test, with TRUS-guided biopsy as the reference standard: sensitivity 63.2%, specificity 63.6%, positive predictive value 75.0%, negative predictive value 50.0%, and overall accuracy 63.3% (data from Table 10).

This prospective observational study evaluated the diagnostic performance of mpMRI, interpreted with the PI-RADS scoring system, in 30 men with suspected prostate cancer, using TRUS-guided biopsy as the reference standard. The majority of participants (40%) were in the 61–70 year age group, with a mean age of 62.1 ± 6.9 years, reflecting the increasing prevalence of prostate cancer with advancing age. This is consistent with Turkbey et al., whose cohort had a mean age of 60.4 years [32], and with Martins et al., whose patients had a mean age of 66.5 ± 6.0 years [33]. Djavan et al. similarly reported higher cancer detection rates in older men [34], reinforcing that MRI-based screening is most relevant in elderly males. All participants were male, consistent with the disease profile of prostate cancer.

Most suspicious lesions in this study were located in the peripheral zone (60%), followed by the transition zone (30%) and central zone (10%). This distribution accords with the known epidemiological pattern in which the peripheral zone is the dominant origin of clinically significant tumors, as reported by Turkbey et al. [32] and Biradar et al. [35], and emphasized in the screening recommendations of Schoots et al. [36]. Although transition- zone tumors are frequently obscured by BPH, mpMRI retains an important role in distinguishing benign from malignant lesions in this zone [35], supporting careful evaluation of both zones.

The mean PSA in this study was 9.36 ± 2.98 ng/mL (median 9.10 ng/mL), reflecting the fact that elevated PSA was the principal indication for imaging and biopsy. Schoots et al. highlighted the trade-off inherent in PSA-only screening between overdiagnosis of indolent  cancers  and  underdetection  of  aggressive  disease  [36],  and  Fazekas  et al. demonstrated that integrating MRI with PSA reduces unnecessary biopsies while maintaining detection of significant cancer [37]. These observations support the combined use of PSA and mpMRI rather than PSA alone.

The distribution of PI-RADS scores, with PI-RADS 3 as the most common category (33.3%), reflects the frequency of indeterminate lesions requiring further evaluation. Yang et al., in a meta-analysis of biopsy-naïve patients, reported a pooled sensitivity of 82% and specificity of 62% for any prostate cancer, improving to 88% and 64% for clinically significant cancer [38]. Launer et al. emphasized that mpMRI improves detection of higher- grade cancers while reducing overdiagnosis [39], and Stabile et al. noted that higher PI- RADS categories carry the greatest probability of clinically significant disease [40]. These findings mirror the graded relationship between PI-RADS score and malignancy observed in the present cohort.

Histopathology confirmed malignancy in 43.3% of patients, indicating that mpMRI screening helped identify a high-risk subgroup requiring biopsy. Ahmed et al. reported that mpMRI achieved markedly improved diagnostic performance over conventional MRI, particularly in the peripheral zone, and reiterated that systematic TRUS biopsy may miss up to 30% of cancers [31]. Biradar et al. similarly reported a sensitivity of 95.83% and specificity of 57.69% for mpMRI in an Indian cohort [35]. Importantly, a statistically significant association was found between PI-RADS category and biopsy result (p = 0.002), with malignancy in 71.4% of PI-RADS ≥4 lesions versus 18.8% of PI-RADS ≤3 lesions—consistent with the higher malignancy odds at increasing PI-RADS thresholds reported by Yang et al. [38] and Fazekas et al. [37].

Individual imaging features were common in this cohort: T2 hypointensity in 60%, diffusion restriction in 56.7%, low ADC values in 53.3%, and early DCE enhancement in 50%. However, none of these individual parameters significantly distinguished benign from malignant lesions (all p > 0.05), a limitation also observed by Launer et al. for PI-RADS 3 lesions [39] and attributable to overlap between malignancy and benign conditions such as BPH and prostatitis. The high sensitivity of DWI in the present study is consistent with the dominant role of diffusion restriction reported by Turkbey et al. [32], and the correlation of low ADC values with higher-grade disease is supported by Delongchamps et al., who showed that adding functional sequences—particularly DWI—significantly improves peripheral-zone cancer detection [41]. DCE enhancement, reflecting tumor vascularity, retains a supportive role, particularly in equivocal lesions, and was associated with malignant vascular characteristics in prior work by Martins et al. [33].

By contrast, advanced-disease markers were highly specific for malignancy. Extra- prostatic extension (16.7%), seminal vesicle invasion (10%), and pelvic lymph node enlargement (13.3%) each occurred exclusively in malignant lesions and showed significant associations with malignancy (p = 0.028, 0.045, and 0.031, respectively), each demonstrating 100% specificity. These findings agree with Schoots et al., who reported high specificity for mpMRI in detecting locally advanced disease [36], and with Fazekas et al., who noted that such features are strongly predictive of aggressiveness and prognosis [37]. Turkbey et al. likewise reported high specificity for detecting seminal vesicle invasion [32]. The identification of these features underscores the value of mpMRI in staging and treatment planning, even though their sensitivity is inherently low because they reflect more advanced disease.

Using PI-RADS ≥4 as the diagnostic threshold, mpMRI demonstrated an overall accuracy of 63.3%, with a sensitivity of 63.2%, specificity of 63.6%, and positive predictive value of 75.0%. These values are broadly consistent with Fazekas et al. [37] and Schoots et al. [36], who reported comparable sensitivity and specificity for mpMRI at a PI-RADS ≥4 cutoff, and the positive predictive value of 75% indicates that lesions classified as positive were frequently confirmed as malignant, supporting the role of mpMRI in guiding biopsy [33]. The negative predictive value of 50% suggests that some cancers, particularly within PI-RADS 3 lesions, were missed, consistent with the recognized limitation of mpMRI in low-grade or small tumors [36]. Population-based screening data from Eklund et al. reinforce the complementary value of MRI-targeted biopsy, which maintained detection of clinically significant cancer while substantially reducing overdiagnosis of insignificant disease [42], and the meta-analysis by de Rooij et al. confirmed the high specificity and favorable predictive values of mpMRI in prostate cancer detection [43].

Taken together, these findings indicate that mpMRI with PI-RADS scoring provides a more accurate and detailed diagnostic approach than PSA, DRE, or TRUS alone. mpMRI offers superior lesion localization, particularly in the peripheral zone where TRUS often misses significant lesions [38], detects tumors that are not palpable on DRE [34], and, when combined with elevated PSA, improves specificity and reduces unnecessary biopsies [35]. The moderate overall diagnostic accuracy in this small cohort should be interpreted in the context of the study’s sample size and the predominance of indeterminate PI-RADS 3 lesions.

STRENGTHS AND LIMITATIONS

This study addresses a major public health problem in an underrepresented population, contributing data on the applicability of mpMRI within an Indian tertiary-care setting where prostate cancer is often underdiagnosed [3]. By evaluating mpMRI—integrating anatomical and functional sequences (T2WI, DWI, DCE)—the study explores a modern imaging pathway that overcomes the low specificity and sampling error of PSA, DRE, and systematic TRUS biopsy [16]. The strong correlation observed between PI-RADS ≥4 and malignancy (71.4%) reinforces the clinical applicability of mpMRI and its potential to guide targeted biopsy [24]. Use of a standardized PI-RADS framework enhanced diagnostic consistency and communication and aligned the study with international reporting practice [26]. The study also has limitations. MRI interpretation and PI-RADS scoring were performed by a single radiologist, which may introduce observer bias; inclusion of multiple readers would have allowed assessment of interobserver variability. The sample size was small (n = 30) and drawn from a single centre, limiting generalizability, and long-term follow-up was not available to evaluate prognostic outcomes. Larger multicentre studies with longitudinal follow-up, cost-effectiveness analysis, and integration of molecular biomarkers are warranted to consolidate and extend these findings.

In this prospective observational study of 30 men with suspected prostate cancer, multiparametric MRI interpreted with the PI-RADS scoring system was a useful non-invasive tool for detection and staging. Prostate cancer predominantly affected elderly men (mean age ± 6.9 years), and most suspicious lesions arose in the peripheral zone. Higher PI-RADS scores correlated strongly with histopathological malignancy, with a significant association between PI-RADS ≥4 and cancer (p = 0.002). Although individual functional and morphological MRI features showed only moderate, non-significant discrimination between benign and malignant lesions, advanced-disease indicators—extra-prostatic extension, seminal vesicle invasion, and pelvic lymph node enlargement—were highly specific and significantly associated with malignancy, underscoring their role in staging. Using PI-RADS ≥4 as the diagnostic threshold, mpMRI achieved a sensitivity of 63.2%, specificity of 63.6%, positive predictive value of 75.0%, and overall accuracy of 63.3%. These results support the integration of mpMRI with PI-RADS into the prostate cancer diagnostic pathway to guide targeted biopsy, improve diagnostic confidence, and assist early detection and staging, while acknowledging the need for larger, multicentre, longitudinal studies.

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