Prostate cancer is one of the most frequently diagnosed malignancies among men worldwide and remains a major cause of cancer-related morbidity and mortality, particularly in developed countries (1). Early and accurate diagnosis is essential for improving patient outcomes and reducing disease progression. Serum prostate-specific antigen (PSA) testing has been widely used as a primary screening tool for prostate cancer, with PSA levels greater than 4.0 ng/mL generally considered suspicious for malignancy. However, PSA lacks specificity, as elevated levels may also be observed in benign conditions such as benign prostatic hyperplasia, prostatitis, and following prostatic manipulation, leading to false-positive results. Conversely, a considerable proportion of prostate cancers may occur in patients with PSA values within the normal range, thereby limiting its sensitivity (2). Digital rectal examination (DRE) is commonly used in conjunction with PSA testing to improve diagnostic accuracy. Combined screening with PSA and DRE has shown improved positive predictive value compared with either modality alone (2,3). In patients with clinical suspicion of malignancy, transrectal ultrasound (TRUS)-guided biopsy remains the standard diagnostic procedure. However, conventional grey-scale TRUS has limited sensitivity, detecting only approximately half of prostate cancers, while systematic biopsy often yields positive results in only a minority of cases (4–6). To improve cancer detection rates, extended-core biopsy protocols have been introduced, but these increase procedural invasiveness and the risk of complications such as rectal bleeding, infection, and urosepsis (7–9). Shear wave elastography (SWE) has recently emerged as a promising imaging modality for prostate cancer detection. By quantitatively assessing tissue stiffness in real time, SWE offers valuable information regarding tissue elasticity, as malignant lesions typically demonstrate increased stiffness compared with benign tissue (10). Several studies have reported encouraging diagnostic accuracy of SWE and suggest its potential role in improving lesion characterization, guiding targeted biopsies, and reducing unnecessary invasive procedures in patients with elevated PSA levels (11,12). Therefore, evaluating the utility of SWE in detecting prostate malignancy may contribute significantly to improving diagnostic precision and optimizing patient management.

This prospective observational study was conducted in the Department of Radiology, JR Medical College and Hospital, Avanampattu, in collaboration with the Department of Urology and Pathology, to assess the utility of Shear Wave Elastography (SWE) in detecting prostate malignancy. The study included 50 male patients with clinical suspicion of prostate carcinoma based on elevated serum prostate-specific antigen (PSA) levels, abnormal digital rectal examination findings, or suspicious lesions detected on conventional transrectal ultrasonography. A consecutive sampling technique was employed, wherein all eligible patients presenting during the study period were enrolled sequentially until the required sample size was achieved. Patients with a prior history of prostate surgery, previously diagnosed or treated prostate malignancy, acute prostatitis, active urinary tract infection, contraindications to transrectal ultrasound-guided biopsy, poor imaging quality due to technical limitations, or those unwilling to provide informed consent were excluded from the study. All enrolled patients underwent transrectal ultrasound-guided SWE evaluation of the prostate using a high-frequency endocavitary probe. Quantitative elasticity measurements were obtained from suspicious focal lesions as well as adjacent normal-appearing prostatic tissue, and stiffness values were recorded in kilopascals (kPa). Areas demonstrating increased stiffness on SWE were considered suspicious for malignancy. Subsequently, all patients underwent systematic transrectal ultrasound-guided prostate biopsy, which served as the reference standard for histopathological confirmation. The SWE findings were correlated with histopathological results to determine diagnostic performance parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of SWE in differentiating malignant from benign prostatic lesions. Data were entered into Microsoft Excel and analyzed using Statistical Package for the Social Sciences (SPSS) version 25.0 (IBM SPSS Statistics). Continuous variables were expressed as mean and standard deviation (SD), while categorical variables were presented as frequencies and percentages. Comparison of mean SWE stiffness values and serum PSA levels between malignant and benign groups was performed using the independent sample t-test. The association between categorical variables such as abnormal digital rectal examination findings, conventional transrectal ultrasonography findings, and SWE positivity was analyzed using the Chi-square test or Fisher’s exact test, wherever appropriate. Diagnostic performance of Shear Wave Elastography was assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy, using histopathological findings as the gold standard. Receiver Operating Characteristic (ROC) curve analysis was performed to determine the optimal SWE stiffness cut-off value for differentiating malignant from benign lesions, and the area under the curve (AUC) was calculated. A p-value of <0.05 was considered statistically significant.

Table 1: Age distribution among the study participants Age (yrs) Frequency Percentage 45-54 8 16.0 55-64 17 34.0 65-74 18 36.0 >75 7 14.0 Table 1 shows the age distribution of the study participants. The majority of patients belonged to the 65–74 years age group, accounting for 18 patients (36%), followed by the 55–64 years age group with 17 patients (34%). Patients aged 45–54 years constituted 8 cases (16%), while those aged more than 75 years accounted for 7 cases (14%). The findings indicate that most participants were in the older age groups, highlighting the increased prevalence of suspected prostate pathology with advancing age. Table 2: Mean andstandard deviation of age in years among the study participants Variable Mean SD Minimum Maximum Age in years 64.8 8.7 45 81 Table 2 depicts the mean age and standard deviation of the study participants. The mean age of the study population was 64.8 ± 8.7 years, indicating a moderate variation in age among participants. Table 3: Type of Prostatic Lesion Distribution Based on Histopathological Examination among the study participants(n = 50) Lesion type Frequency Percentage Benign 22 44.0 Malignant 28 56.0 Table 3 shows the distribution of prostatic lesions among the study participants based on histopathological examination. Out of the total 50 patients, 28 patients (56.0%) were diagnosed with malignant prostatic lesions, while 22 patients (44.0%) had benign lesions. The higher proportion of malignant lesions observed in the study indicates that a considerable number of patients presenting with clinical suspicion of prostate pathology were confirmed to have malignancy on histopathological evaluation. Table 4: Diagnostic Performance of Shear Wave Elastography (SWE) in Detecting Prostate Malignancy among the study participants(n = 50) Variables Malignant lesions (n=28) Benign lesions (n=22) P value Mean SWE stiffness (kPa) 86.4 ± 14.8 42.7 ± 11.3 0.001* Mean PSA level (ng/mL) 18.6 ± 5.9 9.8 ± 3.7 0.001* Abnormal DRE findings 22 (78.6%) 6 (27.3%) 0.01* Suspicious lesion on conventional TRUS 24 (85.7%) 9 (40.9%) 0.02* SWE positive for malignancy 26 (92.9%) 4 (18.2%) 0.001* Table 4 demonstrates the diagnostic performance of Shear Wave Elastography (SWE) in detecting prostate malignancy among the study participants. The mean SWE stiffness value was significantly higher in malignant lesions (86.4 ± 14.8 kPa) compared to benign lesions (42.7 ± 11.3 kPa) (p = 0.001), indicating increased tissue stiffness in malignant prostate lesions. Similarly, the mean serum PSA level was significantly elevated in the malignant group (18.6 ± 5.9 ng/mL) compared to the benign group (9.8 ± 3.7 ng/mL) (p = 0.001). Abnormal digital rectal examination (DRE) findings were observed in 78.6% of malignant cases compared to 27.3% of benign cases (p = 0.01). Suspicious lesions detected on conventional transrectal ultrasonography (TRUS) were noted in 85.7% of malignant lesions and 40.9% of benign lesions (p = 0.02). Furthermore, SWE positivity for malignancy was significantly higher in malignant lesions (92.9%) compared to benign lesions (18.2%) (p = 0.001). These findings highlight the strong diagnostic accuracy and clinical utility of SWE in differentiating malignant from benign prostatic lesions. Table 5:Diagnostic Accuracy of SWE among the study participants Diagnostic Parameter Value (%) 95% Confidence Interval Sensitivity 92.9 76.5 – 98.9 Specificity 81.8 59.7 – 94.8 Positive Predictive Value (PPV) 86.7 69.3 – 96.2 Negative Predictive Value (NPV) 90.0 68.3 – 98.8 Overall Diagnostic Accuracy 88.0 75.7 – 95.5 Area Under ROC Curve (AUC) 0.91 0.83 – 0.98 Table 5 illustrates the diagnostic accuracy of Shear Wave Elastography (SWE) in detecting prostate malignancy among the study participants. SWE demonstrated a high sensitivity of 92.9% (95% CI: 76.5–98.9), indicating its excellent ability to correctly identify malignant lesions. The specificity was 81.8% (95% CI: 59.7–94.8), reflecting good accuracy in differentiating benign lesions from malignant ones. The positive predictive value (PPV) was 86.7% (95% CI: 69.3–96.2), while the negative predictive value (NPV) was 90.0% (95% CI: 68.3–98.8), demonstrating the reliability of SWE in predicting both positive and negative cases. The overall diagnostic accuracy of SWE was 88.0% (95% CI: 75.7–95.5), suggesting strong overall performance as a diagnostic tool. Furthermore, the area under the ROC curve (AUC) was 0.91 (95% CI: 0.83–0.98), which indicates excellent discriminative ability of SWE in distinguishing malignant from benign prostatic lesions. These findings support the clinical usefulness of SWE as an effective non-invasive imaging modality for the detection of prostate malignancy.

The present study evaluated the diagnostic utility of Shear Wave Elastography (SWE) in differentiating benign and malignant prostatic lesions and demonstrated its high diagnostic performance as a non-invasive imaging modality. The mean age of the study participants was 64.8 ± 8.7 years, with the majority belonging to the 65–74 years age group (36%), indicating that prostate pathology predominantly affects elderly males. These findings are consistent with the study by Correas et al who reported a mean age of 66.3 years among patients undergoing SWE evaluation for suspected prostate malignancy, highlighting the increasing incidence of prostate carcinoma with advancing age due to cumulative genetic and hormonal alterations in prostatic tissue (11). Similarly, Barr et al. observed that most prostate cancer patients evaluated using elastography were above 60 years of age, which supports the age distribution observed in the present study (10). In contrast, Woo et al. reported a relatively younger mean age of 61.2 years, possibly due to earlier screening practices and increased awareness in their study population (12). Histopathological examination in the present study revealed that 56% of lesions were malignant, while 44% were benign. This higher prevalence of malignant lesions is comparable to the findings of Sravani et al., who reported malignancy in 58% of clinically suspicious cases (13). Similarly, Pozzi et al. demonstrated a malignancy detection rate of 54%, emphasizing the value of targeted imaging techniques in high-risk patients (14). However, Pallwein et al reported a lower malignancy detection rate of 41%, which may be attributed to differences in patient selection criteria and inclusion of patients with lower PSA levels (15). A major finding of the present study was the significantly higher mean SWE stiffness value in malignant lesions (86.4 ± 14.8 kPa) compared to benign lesions (42.7 ± 11.3 kPa; p = 0.001). This finding is in close agreement with Correas et al., who reported mean stiffness values of 94 ± 20 kPa for malignant lesions and 45 ± 16 kPa for benign lesions, establishing a clear distinction in tissue elasticity (11). Likewise, Barr et al documented significantly increased stiffness in malignant lesions, with values exceeding 80 kPa, suggesting that increased cellular density and stromal fibrosis contribute to reduced tissue compliance (10). In contrast, Woo et al. observed slightly lower stiffness values for malignant lesions (73.5 ± 12.6 kPa), possibly due to technical variations in SWE equipment and differing lesion grades (12). The present study also demonstrated significantly elevated mean PSA levels in malignant lesions (18.6 ± 5.9 ng/mL) compared to benign lesions (9.8 ± 3.7 ng/mL; p = 0.001). These results are comparable to those reported by El Farhaoui et al who found significantly higher PSA values among malignant cases (16). Elevated PSA remains a valuable adjunctive marker; however, its limited specificity underscores the need for imaging modalities such as SWE to improve diagnostic precision. Abnormal digital rectal examination (DRE) findings were significantly more frequent in malignant lesions (78.6%) than benign lesions (27.3%; p = 0.01), consistent with the findings of Richards et al., who reported abnormal DRE findings in 74% of confirmed malignant cases (17). Similarly, suspicious lesions on conventional TRUS were observed in 85.7% of malignant lesions in the present study, which aligns with the observations of Pallwein et al who demonstrated a detection rate of 82% with grayscale TRUS (15). However, conventional TRUS lacks sufficient specificity, often failing to distinguish benign inflammatory changes from malignant lesions. The most significant finding of the present study was the high SWE positivity for malignancy (92.9%), reflecting the superior ability of SWE to identify malignant lesions. This closely correlates with Barr et al., who reported sensitivity values ranging from 85–95% for SWE in prostate cancer detection (10). The present study demonstrated a sensitivity of 92.9%, specificity of 81.8%, PPV of 86.7%, NPV of 90.0%, and overall diagnostic accuracy of 88.0%, with an AUC of 0.91. These findings are highly comparable to those of Correas et al., who reported sensitivity of 90.4%, specificity of 80.8%, and AUC of 0.89 (11). Similarly, Woo et al. documented sensitivity and specificity of 89.1% and 78.6%, respectively (12). The slightly higher sensitivity observed in the present study may be attributed to careful patient selection and optimized SWE acquisition protocol. However, the specificity was marginally lower compared to some previous studies, which may be explained by overlap in stiffness values between malignant lesions and chronic prostatitis, a known limitation of elastography. Despite this, the overall findings strongly support SWE as a valuable adjunct to conventional TRUS and PSA testing for improving diagnostic confidence and guiding targeted prostate biopsies. In summary, the present study demonstrates that SWE provides excellent discriminatory ability in detecting prostate malignancy, with findings largely comparable to previously published literature. Its high sensitivity, good specificity, and non-invasive nature make it a promising imaging modality for routine evaluation of clinically suspected prostate cancer.

The present study concludes that Shear Wave Elastography (SWE) is a highly effective and reliable non-invasive imaging modality for differentiating benign from malignant prostatic lesions. The significantly higher stiffness values observed in malignant lesions, along with its high sensitivity (92.9%), specificity (81.8%), overall diagnostic accuracy (88.0%), and excellent area under the ROC curve (0.91), demonstrate its strong diagnostic performance in detecting prostate malignancy. The study also confirms that prostate malignancy is more prevalent in elderly males, with the majority of affected patients belonging to the 65–74 years age group. The strong correlation of SWE findings with histopathological diagnosis highlights its clinical utility as an important adjunct to conventional diagnostic tools such as serum PSA estimation, digital rectal examination, and transrectal ultrasonography. Although minor overlap in stiffness values may occur in certain benign inflammatory conditions, SWE offers superior tissue characterization and improves lesion localization for targeted biopsy. Therefore, SWE can be considered a valuable addition to routine prostate evaluation protocols, with the potential to enhance early diagnosis, improve diagnostic confidence, reduce unnecessary biopsies, and facilitate timely management of prostate cancer.

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