Role of targeted biopsy, perilesional biopsy, random biopsy, and their combination in the detection of clinically significant prostate cancer by mpMRI/transrectal ultrasonography fusion biopsy in confirmatory biopsy during active surveillance program.

BACKGROUND: Based on the findings of different trials in biopsy naïve patients, target biopsy (TB) plus random biopsy (RB) during mpMRI-guided transrectal ultrasound fusion biopsy (FB) are often also adopted for the biopsy performed during active surveillance (AS) programs. At the moment, a clear consensus on the extent and modalities of the procedure is lacking. OBJECTIVE: To evaluate the increase in diagnostic accuracy achieved by perilesional biopsy (PL) and different RB schemes during FB performed in AS protocol. DESIGN, SETTING, AND PARTICIPANTS: We collected prospectively the data of 112 consecutive patients with low- or very-low-risk prostate cancer; positive mpMRI underwent biopsy at a single academic institution in the context of an AS protocol. INTERVENTION(S): mpMRI/transrectal US FB with Hitachi RVS system with 3 TB and concurrent transrectal 24-core RB. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The diagnostic yield of the different possible biopsy schemes (TB only; TB + 4 perilesional (PL) cores; TB + 12-core RB; TB + 24-core RB) was compared by the McNemar test. Univariable and multivariable regression analyses were adopted to identify predictors of any cancer, Gleason grade group (GGG) ≥2 cancers, and the presence of GGG≥2 cancers in the larger schemes only. RESULTS AND LIMITATIONS: The detection rate of GGG ≥2 cancers increased to 30%, 39%, and 49% by adding 4 PL cores, 14, and 24 RB cores, respectively, to TB cores (all p values <0.01). On the whole, TB alone, 14-core RB, and 24-core-RB identified 38%, 47%, and 56% of all the GGG ≥2 cancers. Such figures increased to 62% by adding to TB 4 PL cores, and to 80% by adding 14 RB cores. Most of the differences were observed in PI-RADS 4 lesions. CONCLUSIONS: We found that PL biopsy increased the detection rate of GGG ≥2 cancers as compared with TB alone. However, the combination of those cores missed a large percentage of the CS cancers identified with larger RB cores, including a 20% of CS cancers diagnosed only by the combination of TB plus 24-core RB.

Role of targeted biopsy, perilesional biopsy, and random biopsy in prostate cancer diagnosis by mpMRI/transrectal ultrasonography fusion biopsy.

PURPOSE: It is still not clear the role of perilesional biopsy (PL) and the extension of the random biopsy (RB) scheme to be adopted during mpMRI-guided ultrasound fusion biopsy (FB). To evaluate the increase in diagnostic accuracy achieved by PL and different RB schemes over target biopsy (TB). METHODS: We collected prospectively 168 biopsy-naïve patients with positive mpMRI receiving FB and concurrent 24-core RB. The diagnostic yields of the different possible biopsy schemes (TB only; TB + 4 PL cores; TB + 12-core RB; TB + 24-core RB) were compared by the McNemar test. Clinically significant (CS) prostate cancer (PCA) was defined according to the definition of the PROMIS trial. Regression analyses were used to identify independent predictors of the presence of any cancer, csPCA. RESULTS: The detection rate of CS cancers increased to 35%, 45%, and 49% by adding 4 PL cores, 12, and 24 RB cores, respectively (all p < 0.02). Notably, the largest scheme including 3 TB and 24 RB cores identified a small but statistically significant 4% increase in detection rate of CS cancer, as compared with the second largest scheme. TB alone identified only 62% of the CS cancers. Such figure increased to 72% by adding 4 PL cores, and to 91% by adding 14 RB cores. CONCLUSIONS: We found that PL biopsy increased the detection rate of CS cancers as compared with TB alone. However, the combination of those cores missed about 30% of the CS cancers identified with larger RB cores, notably including a considerable 15% of cases located contralaterally to the index tumor.

Diagnosis of clinically significant prostate cancer after negative multiparametric magnetic resonance imaging.

Introduction: The diagnostic pathway after a negative magnetic resonance imaging (nMRI) exam is not clearly defined. The aim of the present study is to define the risk of prostate adenocarcinoma (PCa) at the prostate biopsy after a negative multiparametric magnetic resonance imaging (mpMRI) exam. Material and methods: Patients with nMRI Prostate Imaging Reporting & Data System (PI-RADS) ≤2 and without a previous diagnosis of PCa were identified among all patients undergoing mpMRI in a single referral center between 01/2016-12/2019. Detailed data about prostate biopsy after nMRI were collected, including any PCa diagnosis and clinically significant PCa diagnosis. [Gleason score (GS) ≥7]. In addition to descriptive statistics, uni and multivariable logistic regression assessed the potential predictors of any PCa and clinically significant prostate cancer (csPCa) at the biopsy after a negative mpMRI. Results: Of 410 patients with nMRI, 73 underwent saturation biopsy. Only prostate-specific antigen (PSA) levels were significantly higher in patients undergoing biopsy (5.2 ng/ml vs 6.4, p <0.001), while Prostate Cancer Research Foundation (SWOP - Stichting Wetenschappelijk Onderzoek Prostaatkanker) risk score and other variables did not differ. A total of 22 biopsies (30.1%) were positive for PCa, GS 6 was diagnosed in 14 patients, GS 7 in 3, GS 8 in 1 and GS 9-10 in 4. csPCa was found in 8 (11%) patients. No significant predictors of any PCa or csPCa were identified at multivariate regression analysis. Conclusions: Despite the good negative predictive value of mpMRI in the diagnosis of prostate cancer, 11% of the patients had csPCa. Specific predictive models addressing this setting would be useful.

Comparison of MRI, PET, and 18F-choline PET/MRI in patients with oligometastatic recurrent prostate cancer.

OBJECTIVES: The aims of the study were (i) to examine the PCa detection rate of 18F-choline (FCH) PET/MRI and (ii) to assess the impact of PET/MRI findings in patients with PCa who develop OMD using PSA response as a biomarker. METHODS: We retrospectively analyzed a cohort of 103 patients undergoing FCH PET/MRI for biochemical recurrence of PCa. The inclusion criteria were (1) previous radical prostatectomy (RP) with or without adjuvant radiotherapy (RT); (2) PSA levels available at the time of PET; (3) OMD, defined as a maximum of 5 lesions on PET/MRI; and (4) follow-up data available for at least 6 months after PET. All images were reviewed by two nuclear medicine physicians and interpreted with the support of two radiologists. RESULTS: Seventy patients were eligible for the study: 52 patients had a positive FCH PET/MRI and 18 had a negative scan. The overall PCa detection rates for MRI, PET, and PET/MRI were 65.7%, 37.1%, and 74.3%, respectively. Thirty-five patients were treated with radiotherapy (RT), 16 received hormonal therapy (HT), 3 had a combined therapy (RT + HT), and 16 (23%) underwent PSA surveillance. At follow-up, PSA levels decreased in 51 patients (73%), most of whom had been treated with RT or RT + HT. Therapeutic management was guided by PET/MRI in 74% of patients, which performed better than MRI alone (68% of patients). CONCLUSION: FCH PET/MRI has a higher detection rate than MRI or PET alone for PCa patients with OMD and PSA levels > 0.5 ng/mL, prompting a better choice of treatment.

Does 1.5 T mpMRI play a definite role in detection of clinically significant prostate cancer? Findings from a prospective study comparing blind 24-core saturation and targeted biopsies with a novel data remodeling model.

BACKGROUND: Multiparametric-magnetic resonance imaging (mpMRI) can accurately detect high-grade and larger prostate cancers (PC). AIMS: To evaluate the ability of 1.5 T magnetic field mpMRI-targeted Prostate Biopsies (PBx) in predicting PC in comparison with blind 24-core saturation PBx (sPBx). METHODS: We prospectively collected data from patients undergoing transrectal sPBx and, if needed, targeted PBx of suspected lesions based on the 16-'region-of-interest' (ROI) PI-RADS graph. Data remodeling: for each 'target' (each suspected lesion at mpMRI), we identified all the 16 'ROIs' into which the lesion extended: these single 'ROIs' were identified as 'macro-targets'. For each 'ROI' and 'macro-target', we compared the mpMRI result with that of a saturation and targeted biopsy (if performed). RESULTS: 1.5T mpMRI showed a PI-RADS value ≥ 3 in 101 patients (82.1%). We found a PC in 50 (40.6%). Negative-positive predictive values for mpMRI were 82-45%, respectively. Of the 22 patients with normal mpMRI, four had a PC, but none had a clinically significant cancer. After the data remodeling, we demonstrated the presence of PC in 228 'ROIs': (a) only in targeted biopsies in 15 'ROIs'/'macro-targets' (6.6%); (b) only in sPBx in 177 'ROIs' (77.6%); (c) in both targeted and sPBx in 36 'ROIs' (15.8%). DISCUSSION: 81.8% of patients with normal 1.5T mpMRI were negative at PBx. Performing only targeted PBx may lead to lack of PC diagnosis in about 50% of patients. CONCLUSIONS: In patients with suspected PC and a previous negative PBx, a normal mpMRI may exclude a clinically significant PC, avoiding sPBx.