Clinicopathological Characteristics of PIRADS 3 Prostate Lesion: A Retrospective Study

Abstract

Introduction

Prostate carcinoma is the most common carcinoma in male. The evaluation of the suspected prostate carcinoma is based on the abnormal digital rectal examination, raised serum prostate specific antigen (PSA), followed by prostate biopsy with or without magnetic resonance imaging (MRI). The Prostate Imaging-Reporting and Data System (PIRADS) uses five-point scale (1–5), and is a global standard image acquisition, interpretation, and reporting protocol providing clinical guidelines for the management of the prostate carcinoma. PIRADS 3 is considered equivocal or intermediate risk for prostate carcinoma. The management of PIRADS 3 lesions without missing the clinically significant carcinoma and avoiding unnecessary biopsies has been a challenge to urologists. The aim of this study is to evaluate the clinicopathological characteristics, and to find out the incidence of clinically significant prostate carcinoma (csPCa) in PIRADS 3 lesion.

Materials and Methods

It is a retrospective study where patients who underwent transrectal ultrasound (TRUS) guided biopsy of prostate for PIRADS 3 lesion diagnosed in multiparametric MRI (mpMRI) from October 2019 to December 2024 were reviewed and data collected for analysis.

Result

During the study period 19% (n = 34/178) had PIRADS 3 lesion. Patients with PIRADS 3 lesion had a mean age of 67 ± 8 years (mean ± standard deviation). About 41% (n = 14/34) of PIRADS 3 prostate lesion had acinar adenocarcinoma of prostate, and 20.5% (7 out of 34) had csPCa. All the csPCa cases had mpMRI lesion size of >10 mm and PSA density >0.2 ng/mL/cc.

Conclusion

There is a significant risk of prostate carcinoma (41%) among the PIRADS 3 prostate lesion. Further evaluation and management of the PIRADS 3 lesion should be based on risk stratification based on index lesion size and PSA density.

 

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Keywords

prostate carcinoma - PIRADS - mpMRI of prostate - prostate specific antigen

Prostate carcinoma (PCa) is the second leading cause of carcinoma-related death in men worldwide with an incidence of 7.3%.[1] Among the Asian countries, the standardized incidence rates of prostate carcinoma is lowest in Nepal (1.5/100,000), after Bhutan.[2] Pre-biopsy magnetic resonance imaging (MRI) of prostate is the next step in the evaluation of patients having abnormal digital rectal examination and/or elevated prostate specific antigen (PSA). Pre-biopsy MRI has negative predictive value of 82.4% for diagnosis of overall PCa and 88.1% for diagnosis of clinically significant prostate carcinoma (csPCa).[3] The prevalence of “any” PCa in PIRADS 3 lesion is 25% (95% CI: 22 to 29%) and csPCa is 11% (95% CI: 8 to 14%).[4]

Prostate Imaging-Reporting and Data System (PIRADS) published by the European Society of Urogenital Radiology (ESUR) is a common terminology devised to standardize the acquisition, interpretation, and reporting of prostate multiparametric MRI (mpMRI) data that was originally adopted from breast imaging assessment in 2012 (PIRADS v1) and later updated in 2015 as PIRADS v2 and 2019 PIRADS v2.1.[5] The PIRADS v2 scoring system depends on diffusion-weighted image (DWI) “scores” in peripheral zone and T2-weighted (T2W) “scores” in transitional zone lesion.[6] PIRADS v2 uses a five-point scale, ranging from 1 to 5. PIRADS categories 1 and 2 have a very low and low risk of csPCa and further biopsy is not recommended. There is a high or very high likelihood of clinically significant carcinoma in PIRADS 4 and 5 categories and prostate biopsy is warranted.[7] [8] PIRADS 3 lesion is called equivocal or indeterminate due to lack of universally agreed definition and highly variable risk of prostate carcinoma (9–46% depending on clinical profile) posing challenge in definitive management. A direct impact on the diagnostic accuracy of prostate carcinoma was observed when they were treated as positive, negative, or excluded.[9] If we consider PIRADS 3 as a “negative,” a quarter of the prostate carcinoma diagnosis would get missed out. On the other hand, if we consider it as a positive disease, there is a risk of overdiagnosis and overtreatment. Studies also showed that the risk of clinically significant PCa among PIRADS 3 was low and most of it could be kept in active surveillance.[9] [10] The primary aim of clinical and radiological evaluation is to improve prostate carcinoma detection rate and avoid unwanted biopsies.[11] There are a number of risk-based models/calculators to guide the optimal management of the PIRADS 3 prostate lesion without compromising the disease outcomes. Age of the patient, PSA kinetics, family history, prior biopsy, and various biomarkers are in use to predict the risk of prostate carcinoma in equivocal cases.[12]

The purpose of this study is to explore the clinicopathological characteristics of PIRADS 3 lesions and find out the detection rate of csPCa in PIRADS 3 lesion by transrectal ultrasound (TRUS) guided needle biopsy of prostate.

Materials and Methods

It is a retrospective study done under urology unit under the Department of Surgery, Nepalese Army Institute of Health Sciences, Nepal, after approval from institutional review committee (IRC-NAIHS Reg No. 1306). The clinical, radiological, and pathological data of the patients diagnosed with PIRADS 3 prostate lesion on mpMRI of prostate from October 2019 to December 2024 were analyzed.

Patients who underwent TRUS guided biopsy of prostate for suspected prostate carcinoma were reviewed and the data were collected using study proforma. The inclusion criteria were patients with PIRADS 3 lesion who underwent TRUS guided prostate biopsy for the first time (biopsy naïve). The exclusion criteria were PIRADS 4 and 5 lesions, finger-guided prostate biopsy, nonsystematic prostate biopsy, prior biopsy, and metastatic prostate carcinoma.

The data collected were independent variables, namely, patient demographics, clinical symptoms, digital rectal examination, prostate volume, serum PSA, PSA density (PSAD), and size and location of lesion on mpMRI of prostate, and the dependent variables, namely, histopathological details of the TRUS guided needle biopsy of prostate. The data collected in study proforma were entered into SPSS 2.0 for analysis. The carcinoma detection rate of csPCa—ISUP grade group ≥2 in PIRADS 3 lesion—and its relationship with PSA density (cut off at 0.1 ng.mL/cc) was measured.[13]

Distribution of the study variables was measured in mean/median ± standard deviation. The difference in measurement were interpreted as statistically significant when p-value was <0.05.

 

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Results

All the patients underwent mpMRI of prostate (3 tesla) for suspected prostate carcinoma based on digital rectal examination and serum PSA value. High-resolution T2-weighted image (T2WI), diffusion-weighted image (DWI), and diffusion contrast enhancement images (DCEI) were obtained and the prostate mpMRI was reported according to PIRADS v2 protocol.[5]

Patients with PIRADS ≥3 underwent systematic as well as cognitive targeted biopsy after confirming sterile urine and normal coagulation profile. Preprocedural 30 to 60 mL glycerin bowel suppositories were given to empty the rectum, and a single dose of 60 mg intramuscular Gentamicin was given for antibiotic prophylaxis. Digital rectal examination was performed. TRUS guided peri-prostatic nerve block was done with 1% lignocaine (10–20 mL) for pain management. The TRUS guided needle biopsy was done with 20 cm/18 G core needle biopsy gun. All core biopsy samples were processed and reported as per the 2019 International Society of Urological Pathology (ISUP) protocols.[13]

Among the cohort of 178 patients subjected to TRUS guided prostate biopsy during the study period, 34 (19%) of them had PIRADS 3 lesions. The mean age of patients was 67 ± 8 years. A total of 20/34 (59%) had abnormal DRE findings. The prostate size, PSA value, and PSAD of the study population are listed in [Table 1].

Table 1 Clinicopathological characteristics of PIRADS 3 lesion

Variables		Biopsy		p-Value
Histopathology for PCa ( n , %)	Negative (20, 59)	isPCa (7, 20.5)	csPCa (7, 20.5)	0.03
Age (years), Mean ± SD	65 ± 9.8	67 ± 7	71 ± 5.2	NS
Prostate volume (cc), Mean ± SD	45.7 ± 26.7	43 ± 15	40 ± 25	NS
Index lesion maximum diameter (mm), Mean	8.0	10.2	18.4
PSA (ng/mL)
Mean range	8.9 4.2–12.4	12.6 6–19.6	14.2 9–26.1	NS
Mean PSA density (ng/mL/cc)	0.06	0.21	0.35	0.01
Location of lesion (PZ/TZ)	18/2	6/1	6/1	NS

Abbreviations: csPCa, clinically significant prostate carcinoma; isPCa, insignificant prostate carcinoma; PCa, prostate carcinoma; PIRADS 3, Prostate Imaging-Reporting and Data System category 3; PSA, prostate specific antigen; PZ, peripheral zones; TZ, transitional zones.

Out of 34 cases, 14 (41%) with PIRADS 3 prostate lesion had proven malignancy on histopathological examination and all were acinar adenocarcinoma. A total of 20.5% (7 out of 34) had clinically significant PCa (ISUP grade group ≥2). The mean PSA density in PCa was >0.2 ng/mL/cc. The mean PSAD in insignificant prostate carcinoma (isPCa) was 0.21 ng/ml/cc and csPCa was 0.35 ng/mL/cc. Majority (85%) of the csPCa had prostate lesion ≥10 mm in size. Low PSA density index PIRADS 3 prostate lesions at transitional zone had lower rate of carcinoma. With cut-off PSA density ≥0.15 ng/mL/cc, the sensitivity and specificity of mpMRI to detect csPCa was 85.7%.

 

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Discussion

The mpMRI utilized three different sequences, namely, T2-weighted (T2W), diffusion-weighted image (DWI), and dynamic contrast enhancement image (DCEI), and evaluated a total of 39 different sectors (38 in prostate, 1 in seminal vesicle, and 1 in urethra) for suspected prostate carcinoma. “Prostate Imaging-Reporting and Data System” (PIRADS) is based on “DWI score” of peripheral zones (PZ) lesions and “T2W score” of transitional zones (TZ) lesions.[6] The PIRADS 3 lesion appears heterogenous with ill-defined margins on T2 and appears isointense or mildly hyperintense on high b-value DWI and focal mild/moderate hypointense on apparent diffusion coefficient (ADC). The PZ DWI score 3, which appears negative for DCE (focal and early enhancement), is given final PIRADS category 3, and if positive (enhancement) given final PIRADS category 4. The TZ score 3 on T2W that has DWI score 4 or less is given final PIRADS category of 3, and the TZ score 3 that has DWI score 5 is given final PIRADS category 4.[6] Multiparametric MRI has been widely used for diagnosis, surveillance, and staging of patients with prostate carcinoma that has negative predictive value of 80 to 90%.[7] According to the “PRECISION Trail” MRI-guided prostate biopsies are superior to standard biopsy with adjusted difference of 12% (95% CI, 4–20; p = 0.005), and prebiopsy MRI can avoid prostate biopsy in 28% of the cases.[14] The diagnostic accuracy is limited by the experience of the radiologist. The current modification of PIRADS into v2 and v2.1 is expected to improve inter-reader variability and simplify PIRADS assessment for better accuracy in terms of detection, localization, characterization, and risk stratification of the index prostate lesion.[15]

About three-quarters of all the MRI for suspected prostate carcinoma patients who have PIRADS ≥3 are likely to undergo invasive procedures. The prevalence of csPCa (ISUP ≥2) in PIRADS 3 biopsy naïve patients is approximately 21% in comparison to 39 and 73% in PIRADS 4 and PIRADS 5 lesions, respectively.[10] The high rate (61–71%) of benign pathology in PIRADS 3 lesion is commonly due to benign hyperplasia, inflammation, or fibrosis resulting in false-positive MRI findings.[10] [16] MRI of prostate often shows no difference in DCE and T2W scores if prostate tumors are sparse or normal.[17] Presence of small infiltrative gland with large intervening stroma, sparse or more densely packed tumor cells in PIRADS 3 lesion tends to have clinically insignificant prostate carcinoma with Gleason grade of 1 to 3.[18] Tumor aggressiveness and the size of the tumor also impact the tumor visibility, detection, and interpretation on prostate MRI. Around 94 to 95% of the tumor volume >0.5 cc is correctly classified by PIRADS. Sparse malignant tissue with volume <0.5 cc is mostly undetectable on MRI and has a high chance of missing it in biopsies.[19] Besides, the interobserver variability among radiologists for PIRADS ≤3 is higher than PIRADS ≥4 (k −0.552), thus impacting the case detection rate in PIRADS 3 lesions.[17]

The prevalence csPCa in PIRADS 3 is 11% (95% CI: 8 to 14%),[4] which are mostly located in the peripheral zone (18.5%) and less frequently in the transition zone (6%).[11] In a multicenter study, the risk of unfavorable prostate carcinoma (ISUP GG 3–5 and/or pT3–4) was 2.3-fold with PSAD between 0.15 and 0.20 ng/mL/cc, and the risk was 5.8-fold for PSAD >0.20 ng/mL/cc.[20] The higher rate (56.7%) of unfavorable disease in radical prostatectomy in this series of PIRADS 3 disease might be due to inclusion of patients with higher PSA densities, median 0.17 ng/mL/cc (IQR: 0.12–0.26), higher number of csPCa (ISUP GG ≥2) in needle biopsy (72%), and prior biopsy patients (33.3%).[20]

In our study, population PSA density, location, and size of index prostate lesions are important predictors of malignancies in PIRADS 3 lesions. Studies have shown the disease progression rate of 20 to 78% even in low-risk disease (ISUP 1), directly depending on the size of the index prostate lesion.[21] It is mentioned that the chance of csPCa with cut-off at index lesion size of 5 to 7 mm is very low and could be monitored with serial MRI only.[21] [22] The carcinoma detection rate in PIRADS 3 is high (>80%) with PSA threshold of ≥4 ng/mL, and with high PSA density (>0.1 ng/mL/cc).[23] [24] The PCa in our study group had high PSA density of >0.2 ng/mL/cc (EAU high-risk group).[12] All lesions with size ≥10 mm resulted in higher incidence of PCa among PIRADS 3 in our case series.

Change in the current practice guidelines to manage PIRADS 3 needs more research evidence. Shifting the approach of target biopsy for PIRADS ≥4 has better interobserver agreement but could miss substantial portion (24%) of the csPCa in biopsy naïve patients. On the other hand, shifting the definition of csPCa to ISUP ≥3 decreases the prevalence of csPCa by half to one-third at more risk of disease progression.[10] Current scientific evidence is not sufficient to replace prostate biopsy with clinical and serial MRI for management of PIRADS 3 lesions, especially due to risk of disease progression, and high false positive rate of MRI.[9]

There are a number of risk assessment models to estimate the risk of PCa in PIRADS 3 lesions, and serum PSA kinetics is the strongest one. Serum PSA, percentage of free PSA, PSA density, age, race, and family history, prior MRI, and prior biopsy are important clinical risk predictors.[12] [25] A recent study by Deniffel and colleagues showed that at the threshold of <10%, normalized ADC (0.81) and PSA density (0.08 ng.nL/cc) outperform other risk models—MRI-ERSCPC risk calculator, lesion volume, and Radtke risk model—in the diagnosis of PCa.[26] There are a number of blood-, urine-, or tissue-based biomarkers under evaluation to diagnose the indolent PCa.[25] EAU guidelines mentioned that Prostate Health Index (PHI) test, four kallikrein (4K) test, and Stockholm3 test have potential role in reducing the number of mpMRI and/or prostate biopsies.[12] 4K score and family history are considered strong predictors of csPCa on biopsy even when the mpMRI is negative.[27] The Proclarix test is considered a better predictor than PSAD and ERSPC MRI model, and could detect 100% of csPCa, and reduce biopsies by 21.3% and detection rate of insignificant tumor by 15.4%.[28]

EAU guidelines outline combining MRI and PSA density pathway to avoid redundant prostate biopsy and detect csPCa. The risk-adapted matrix table for prostate biopsy decision protocol does not recommend biopsy if PSA density is <0.1 ng.mL/cc in PIRADS 3 lesion where the risk of csPCa is in the range of 5 to 10%.[12] Similarly, “AUA/SUO Early Detection of Prostate Carcinoma Algorithm” recommends risk-based and adjunctive biomarker–based risk stratification before proceeding with prostate biopsy. Prostate MRI is recommended before repeat biopsy and is optional for initial biopsy.[25] A single assessment tool is not sufficient. Multivariate risk modeling combining clinical, biochemical, and radiological data could be helpful to plan the management of PIRADS 3 prostate lesion.[10]

Our study is limited due to retrospective design, single-center study with small sample size. Although the prevalence of PCa in Nepal is one of the lowest among Asian countries, we have noticed rise in the incidence of the suspected prostate carcinoma due to wider use of clinical screening and prostate MRI. MRI-based evaluation and ultrasound-guided prostate biopsy are not routine practice in Nepal until recently, primarily due to scarce resources and expertise.[29] [30] The population-based screening showed cancer detection rate of 0.73 based on finger-guided tru-cut biopsy.[29] In a prospective study done in 2020 in Nepal, the carcinoma detection rate of TRUS guided prostate biopsy was 0.80.[30] We recommend more rigorous clinicopathological evaluation and assessment of the risk predictors for the optimal cost-effective management of the PIRADS 3 prostate lesion in the limited resources settings.

 

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Conclusion

The overall incidence of prostate carcinoma in PIRADS 3 lesion is 41%, out of which 20% is csPCa. Prostate biopsy, when based on combined MRI characterization, and clinical and biochemical parameters, is likely to outweigh the harm of not doing biopsies.

 

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Conflict of Interest

None declared.

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Publikationsverlauf

Eingereicht: 26. März 2025

Angenommen: 13. August 2025

Artikel online veröffentlicht:
10. September 2025