MRI-guided Biopsy Research Articles

Development and validation of a nomogram based on biparametric MRI PI-RADS v2.1 and clinical parameters to avoid unnecessary prostate biopsies

BackgroundBiparametric MRI (bpMRI) is a faster, contrast-free, and less expensive MRI protocol that facilitates the detection of prostate cancer. The aim of this study is to determine whether a biparametric MRI PI-RADS v2.1 score-based model could reduce unnecessary biopsies in patients with suspected prostate cancer (PCa). MethodsThe patients who underwent MRI-guided biopsies and systematic biopsies between January 2020 and January 2022 were retrospectively analyzed. The development cohort used to derive the prediction model consisted of 275 patients. Two validation cohorts included 201 patients and 181 patients from 2 independent institutions. Predictive models based on the bpMRI PI-RADS v2.1 score (bpMRI score) and clinical parameters were used to detect clinically significant prostate cancer (csPCa) and compared by analyzing the area under the curve (AUC) and decision curves. Spearman correlation analysis was utilized to determine the relationship between International Society of Urological Pathology (ISUP) grade and clinical parameters/bpMRI score.ResultsLogistic regression models were constructed using data from the development cohort to generate nomograms. By applying the models to the all cohorts, the AUC for csPCa was significantly higher for the bpMRI PI-RADS v2.1 score-based model than for the clinical model in both cohorts (p < 0.001). Considering the test trade-offs, urologists would agree to perform 10 fewer bpMRIs to avoid one unnecessary biopsy, with a risk threshold of 10–20% in practice. Correlation analysis showed a strong correlation between the bpMRI score and ISUP grade. Conclusion A predictive model based on the bpMRI score and clinical parameters significantly improved csPCa risk stratification, and the bpMRI score can be used to determine the aggressiveness of PCa prior to biopsy.

Results of Magnetic Resonance Imaging (MRI) Screening in Patients at High Risk for Breast Cancer.

Screening MRI as an adjunct to mammography is recommended by the ACS for patients with a lifetime risk for breast cancer > 20%. While the benefits are clear, MRI screening is associated with an increase in false-positive results. The purpose of this study was to analyze our institutional database of high-risk patients and assess the uptake of screening MRI examinations and the results of those screenings. Our institutional review board-approved High-Risk Breast Cancer Database was queried for patients enrolled from January 2017 to January 2023 who were at high risk for breast cancer in a comparative analysis between those who were screened versus not screened with MRIs. Variables of interest included risk factor, background, MRI screening uptake, and frequency and results of image-guided breast biopsies. A total of 254 of 1106 high-risk patients (23%) had MRI screening. Forty-six of 852 (5.3%) patients in the non-MRI-screened cohort and nine of 254 (3.5%) patients in the MRI-screened cohort were diagnosed with a malignant lesion after image-guided biopsy (p = 0.6). There was no significant difference between MRI and non-MRI guided biopsies in detecting breast cancer. All malignant lesions were T1 or in situ disease. The 254 patients in the MRI-screened group underwent 185 biopsies. Fifty-seven percent of MRI-guided biopsies yielded benign results. Although the addition of MRI screening in our high-risk cohort did not produce a significant number of additional cancer diagnoses, patients monitored in our high-risk cohort who developed breast cancer were diagnosed at very early stages of disease, underscoring the benefit of participation in the program.

Results from the PRIMA Trial: Comparison of the STHLM3 Test and Prostate-specific Antigen in General Practice for Detection of Prostate Cancer in a Biopsy-naïve Population

BackgroundCurrent management of prostate cancer (PC) lacks biomarker tests and diagnostic procedures that can accurately distinguish clinically significant and clinically insignificant PCs at an early stage of the disease. ObjectiveTo compare the Stockholm 3 (STHLM3) test and prostate-specific antigen (PSA) as entry tests for magnetic resonance imaging (MRI) in a prospective study of PC diagnosis in general practice. Design, setting, and participantsParticipants were biopsy-naïve men aged 50–69 yr who had a PSA test in general practice. Participants with PSA 1–10 ng/ml also had an STHLM3 test and were referred for MRI if the STHLM311 test was positive (risk ≥11%) and/or PSA ≥3 ng/ml, and to targeted MRI-guided biopsy (MRGB) if their Prostate Imaging-Reporting and Data System (PI-RADS) score was ≥3. Outcome measurements and statistical analysisThe primary outcome was the number of International Society of Urological Pathology grade group ≥2 (GG ≥2) cases detected with a positive STHLM311 test versus PSA ≥3 ng/ml. Post hoc analysis was performed using a higher STHLM3 test cutoff (risk ≥15%; positive STHLM315 test). Results and limitationsBetween January 2018 and December 2021, we recruited 1905 men. The STHLM3 test was performed in 1134 participants. Of these, 437 underwent MRI and 117 underwent MRGB, which detected 38 (32.5%) GG ≥2 and 52 (44.4%) with GG 1 cases. In comparison to PSA ≥3 ng/ml, a positive STHLM311 test increased detection of GG ≥2 from 30 to 37 cases (23.3%, 95% confidence interval [CI] 5.6–52.2%) and detection of GG 1 from 37 to 50 cases (35.1%, 95%CI 11.6–66.7%). STHLM315 positivity did not differ from PSA ≥3 ng/ml regarding detection of GG ≥2 PC (30 vs 32; 6.6%, 95% CI −8.1% to 25.9%), GG 1 PC (37 vs 37; 0.0%, 95% CI −19.6% to 25.0%), or MRGB use (88 vs 83; −5.7%, 95% CI −17.9% to 7.4%), but reduced MRI scans from 320 to 236 (−26.2%, 95% CI −33.1% to −18.9%). ConclusionsThe STHLM311 test improved sensitivity but not specificity for detection of GG ≥2 PC in the clinical setting of nonsystematic PC testing in general practice. Further studies are needed to validate a possible benefit of using a higher cutoff for STHLM3 positivity as an entry test for MRI. Patient summaryWe used a test called STHLM3 for detection of prostate cancer in general practice and compared its performance to the conventional PSA (prostate-specific antigen) test. We found that STHLM3 test results of 11% or above were not better at selecting men for MRI (magnetic resonance imaging) scans than the PSA test with a cutoff of 3 ng/ml or above. Analysis suggested that a higher cutoff for a positive STHLM3 test may improve selection of men for MRI scans, but further validation is needed.

Percutaneous Magnetic Resonance Imaging-Guided Coaxial Cutting Needle Biopsy of Pancreatic Lesions: Diagnostic Accuracy and Safety.

To appraise the diagnostic performance of magnetic resonance imaging-guided percutaneous coaxial cutting needle biopsy of pancreatic lesions using a 0.4-T open magnetic resonance imaging scanner with optical tracking navigation. This retrospective study included 158 patients who underwent magnetic resonance imaging-guided pancreatic lesion biopsy procedures from May 2019 to December 2020. Two to four specimens were collected from each patient. Pathological diagnosis and clinical follow-ups were conducted to establish the final diagnosis. The procedures were evaluated for sensitivity, specificity, positive and negative predictive values, diagnostic accuracy, and complications. The Cardiovascular and Interventional Radiological Society of Europe guidelines were used to classify complications. Biopsy pathology revealed 139 pancreatic tumor malignancies and 19 benign pancreatic lesions. Finally, 151 patients were diagnosed with pancreatic malignancy and 7 with benign disease confirmed by surgery, re-biopsy, and clinical follow-up. The sensitivity, specificity, positive and negative predictive value, and accuracy for diagnosis of pancreatic diseases were 92.1%, 100%, 100%, 36.8%, and 92.4%, respectively. The biopsy accuracy was significantly related to the size (≤ 2cm, 76.2%; 2-4cm, 94.0%; > 4cm, 96.2%, P = .02) and not the lesion's location (head of pancreas, 90.7%; neck of pancreas, 88.9%; body of pancreas, 94.3%; tail of pancreas, 96.7%, P = .73). Minor complications included two patients experiencing mild abdominal pain and two with a minor occurrence of hemorrhage. Percutaneous magnetic resonance imaging-guided pancreatic lesion biopsy combined with optical navigation has high diagnostic accuracy and is safe for clinical practice. Level of Evidence Level 4, Case-series.

Racial differences in the utilization of MRI-guided biopsy before prostate cancer diagnosis.

5093 Background: Most low-risk prostate cancer (PCa) patients undergo active surveillance (AS). Compared with Whites, Blacks are more likely to opt for AS and suffer a higher risk of cancer progression while on AS. A primary concern of AS is the likelihood of missing clinically significant cancer. Transrectal ultrasound-guided biopsy is the most common method for diagnosing and grading PCa; however, this method often misses anterior PCa. Magnetic resonance imaging (MRI) allows clinicians to identify better and detect PCa; however, current guidelines on MRI-guided biopsy (MRI-GB) are inconsistent. This population-based study aimed to examine the utilization of MRI-GB 6 months before PCA diagnosis over time by race in the US. Methods: We used SEER-Medicare data to identify men diagnosed with PCa between January 1, 2012, to December 31, 2017, and excluded patients missing the date of diagnosis, being diagnosed at death, enrolled in HMO, or having no continuous A and B coverage six months before diagnosis. We used the CPT codes to identify prostate biopsy and MRI use. Multivariable logistic regression was used to evaluate racial disparity in MRI use six months before PCa. The model included covariates age, race, SEER region, marital status, state buy-in for Medicare (a poverty indicator), education, income, Charlson comorbidity index, and procedure (MRI) year. Results: Among 38,612 eligible men, MRI use six months before PCa diagnosis increased from 2012 to 2017 (3.2% to 24.3% among Whites, 1.8% to 14.2% among Blacks). Compared with Whites, Blacks were 38% less likely to receive pre-diagnosis MRI (OR=0.62, 95% CI 0.52-0.74). Besides race, having state buy-in for Medicare (OR=0.44; 95% CI 0.30-0.65) and geographic regions (Central vs. West OR=0.40; 95% CI 0.34-0.45) were strong predictors of lower utilization of MRI. Conclusions: The gap in the utilization of MRI may exacerbate racial disparities in PCa. Future studies are needed to identify potential barriers to adopting MRI for PCa workups.

MRI-guided thoraco-abdominal percutaneous needle biopsy: our initial experience.

The aim of this study is to describe the technique and to report early results of thoraco-abdominal biopsies in the Interventional Magnetic Resonance Imaging Suite (IMRIS). We prospectively evaluated patients with indications for MRI-guided biopsy between January 2021 and May 2022. Exclusion criteria were indication for US-/CT-guided biopsy, contraindication to percutaneous biopsy, inability to lie flat for at least 30min, claustrophobic, severe obesity, or non-MRI compatible devices. Biopsies were performed by 3 interventional radiologists, with at least 8years of experience in oncological interventional radiology. Epidemiological, clinical, procedural, and histopathological data were retrospectively collected. From an initial population of 117 patients, 57 patients (32 male, mean age 64 ± 8 y) were finally enrolled. All 57 patients suspected thoraco-abdominal malignant lesions finally underwent MRI-guided percutaneous biopsy. The mean duration of the entire procedure was 37min (range 28-65min); the mean duration of the total needle-in-patient time was 10min (range 6-19min). Technical and clinical success were obtained for all the biopsies performed. Malignancy was demonstrated in 47/57 (82%) cases and benignancy in the remaining 10/57 (18%) cases. No major complications were detected after the biopsies; two minor compliances (severe pain) occurred and were managed conservatively. Our initial experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. The reported data associated with the best comfort for the patient and for the operator make the use of MRI a valid alternative to other methods, especially in lesions that are difficult to approach via US or CT. Interventional MRI is one of the most important innovations available for interventional radiologists. This method will broaden the diagnostic and therapeutic possibilities, allowing treatment of lesions up to now not approachable percutaneously. For this, it is necessary to start publishing the data of the few groups that are developing the method. • To evaluate the use of MRI as a guide for percutaneous biopsies of various districts. • Our preliminary experience confirms experience demonstrated the technical feasibility and the accuracy of MRI-guided biopsies of thoraco-abdominal masses. • Interventional MRI can become the reference method for percutaneous biopsies in particular for lesions with difficult percutaneous approach.

Cancer detection and complications in transperineal prostate biopsy, with antibiotics only when indicated.

To describe the prostate cancer (PCa) detection rate, including clinically significant prostate cancer (csPCa), in a large cohort of patients who underwent transperineal ultrasonography-guided systematic prostate biopsy (TPB-US) using a probe-mounted transperineal access system, with magnetic resonance imaging (MRI) cognitive fusion in case of a Prostate Imaging-Reporting and Data System grade 3-5 lesion, under local anaesthesia in an outpatient setting. Additionally, to compare the incidence of procedure-related complications with a cohort of patients undergoing transrectal ultrasonography-guided (TRB-US) and transrectal MRI-guided biopsies (TRB-MRI). This was an observational cohort study in men who underwent TPB-US prostate biopsy in a large teaching hospital. For each participant, prostate-specific antigen level, clinical tumour stage, prostate volume, MRI parameters, number of (targeted) prostate biopsies, biopsy International Society of Uropathology (ISUP) grade and procedure-related complications were assessed. csPCa was defined as ISUP grade ≥2. Antibiotic prophylaxis was only given in those with an increased risk of urinary tract infection. A total of 1288 TPB-US procedures were evaluated. The overall detection rate for PCa in biopsy-naive patients was 73%, and for csPCa it was 63%. The incidence of hospitalization was 1% in TPB-US (13/1288), compared to 4% in TRB-US (8/214) and 3% in TRB-MRI (7/219; P = 0.002). Contemporary combined systematic and target TPB-US with MRI cognitive fusion is easy to perform in an outpatient setting, with a high detection rate of csPCa and a low incidence of procedure-related complications.

Phantom-based assessment of motion and needle targeting accuracy of robotic devices for magnetic resonance imaging-guided needle biopsy.

The current study proposes simple methods for assessing the performance of robotic devices intended for Magnetic Resonance Imaging (MRI)-guided needle biopsy. In-house made agar-based breast phantoms containing biopsy targets served as the main tool in the evaluation process of an MRI compatible positioning device comprising a needle navigator. The motion accuracy of mechanical stages was assessed by calliper measurements. Laboratory evaluation of needle targeting included a repeatability phantom test and a laser-based method. The accuracy and repeatability of needle targeting was also assessed by MRI. The maximum error of linear motion for steps up to 10mm was 0.1mm. Needle navigation relative to the phantom and alignment with the various biopsy targets were performed successfully in both the laboratory and MRI settings. The proposed biopsy phantoms offered tissue-like signal in MRI and good haptic feedback during needle insertion. The proposed methods could be valuable in the process of validating the accuracy of MRI-guided biopsy robotic devices in both laboratory and real environments.

Impact of prostate imaging quality (PI-QUAL) score on the detection of clinically significant prostate cancer at biopsy

PurposeTo investigate the impact of Prostate Imaging Quality (PI-QUAL) scores on the diagnostic performance of multiparametric MRI (mpMRI) in a targeted biopsy cohort. Patients and methods300 patients who underwent both mpMRI and biopsy were included. PI-QUAL scores were retrospectively assigned by two radiologists in consensus and were correlated to pre-biopsy PI-RADS scores and biopsy outcomes. Clinically significant prostate cancer (csPCa) was defined as ISUP grade ≥ 2. ResultsImage quality was optimal (PI-QUAL ≥ 4) in 249/300 (83%) and suboptimal (PI-QUAL < 4) in 51/300 (17%). The proportion of PI-RADS 3 scores referred for biopsy was higher in scans of suboptimal vs optimal quality (51% vs 33%). For PI-QUAL < 4 scans, the positive predictive value (PPV) was lower compared to PI-QUAL ≥ 4 (35% [95%CI: 22, 48] vs 48% [95%CI: 41, 55]; difference −13% [95%CI: −27, 2]; p 0.090), as was the detection rate of csPCa in both PI-RADS 3 and PI-RADS 4–5 (15% vs 23% and 56 vs 63%, respectively). The overall MRI quality increased over time. ConclusionsScan quality may affect the diagnostic performance of prostate mpMRI in patients undergoing MRI-guided biopsy. Scans of suboptimal quality (PI-QUAL < 4) were associated with lower PPV for csPCa.

Prostate Health Index Density Outperforms Prostate-specific Antigen Density in the Diagnosis of Clinically Significant Prostate Cancer in Equivocal Magnetic Resonance Imaging of the Prostate: A Multicenter Evaluation.

We compare Prostate Health Index, Prostate Health Index density, and PSA density in predicting clinically significant prostate cancer in MRI-guided prostate biopsy. This is a multicenter evaluation of prospectively maintained prostate biopsy databases at 10 urology centers. Men with Prostate Health Index and MRI-guided targeted and systematic prostate biopsy performed and without prior prostate cancer diagnosis were included. The additional value of PSA density, Prostate Health Index, and Prostate Health Index density to MRI PI-RADS (Prostate Imaging Reporting & Data System) score was evaluated with multivariable analyses, area under the curve, and decision curve analyses. The proportion of unnecessary biopsies that can be avoided are estimated for clinically significant prostate cancer (International Society of Urological Pathology group ≥2 prostate cancer). A total of 1,215 men were analyzed. Prostate cancer and clinically significant prostate cancer were diagnosed in 51% (617/1,215) and 35% (422/1,215) of men, respectively. Clinically significant prostate cancer was diagnosed in 4.4% (3/68), 15% (72/470), 39% (176/446), and 74% (171/231) of highest PI-RADS score of 2, 3, 4, and 5 lesions, respectively. In multivariable analyses, independent predictors for clinically significant prostate cancer detection included Prostate Health Index (OR 1.04), prostate volume (OR 0.97), and PI-RADS score 4 (OR 2.81) and 5 (OR 8.34). Area under the curve for clinically significant prostate cancer of PI-RADS + Prostate Health Index density (0.85) was superior to PI-RADS + PSA density (0.81), Prostate Health Index density (0.81), Prostate Health Index (0.78), PI-RADS (0.76), PSA density (0.72), and PSA (0.60) in the whole cohort, and the superiority of Prostate Health Index density was also observed in PI-RADS 3 lesions. Decision curve analysis showed Prostate Health Index density achieving the best net clinical benefit in PI-RADS 3 or 4 cases. Among PI-RADS 3 lesions, using cutoffs of PSA density 0.15, Prostate Health Index 38.0, and Prostate Health Index density 0.83 could reduce 58%, 67%, and 72% of unnecessary biopsies, respectively. Prostate Health Index density outperformed Prostate Health Index or PSA density in clinically significant prostate cancer detection in men with multiparametric MRI performed, and further reduced unnecessary biopsies in PI-RADS 3 lesions.

Assessment of the burden of outpatient clinic and MRI-guided needle muscle biopsies as reported by patients with facioscapulohumeral muscular dystrophy

Muscle biopsies are used in clinical trials to measure target engagement of the investigational product. With many upcoming therapies for patients with facioscapulohumeral dystrophy (FSHD), the frequency of biopsies in FSHD patients is expected to increase. Muscle biopsies were performed either in the outpatient clinic using a Bergström needle (BN-biopsy) or in a Magnetic Resonance Imaging machine (MRI-biopsy). This study assessed the FSHD patients’ experience of biopsies using a customized questionnaire. The questionnaire was sent to all FSHD patients who had undergone a needle muscle biopsy for research purposes, inquiring about biopsy characteristics and burden, and willingness to undergo a subsequent biopsy. Forty-nine of 56 invited patients (88%) completed the questionnaire, reporting on 91 biopsies. The median pain score (scale 0-10) during the procedure was 5 [2-8], reducing to 3 [1-5] and 2 [1-3] after one and 24 h, respectively. Twelve biopsies (13.2%) resulted in complications, eleven resolved within 30 days. BN-biopsies were less painful compared to MRI-biopsies (median NRS: 4 [2-6] vs. 7 [3-9], p = 0.001). The burden of needle muscle biopsies in a research setting is considerate and should not be underestimated. MRI-biopsies have a higher burden compared to BN-biopsies.

Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer.

Active surveillance (AS) represents a standard of care of low-risk prostate cancer (PCa). However, the identification and monitoring of AS candidates remains challenging. Microultrasound (microUS) is a novel high-resolution imaging modality for transrectal ultrasonography (TRUS). We explored the impact of microUS TRUS and targeted biopsies in mpMRI-guided confirmatory biopsies. Between October 2017 and September 2021, we prospectively enrolled 100 patients scheduled for MRI-guided confirmatory biopsy at 1 year from diagnosis of ISUP 1 PCa. TRUS was performed using the ExactVu microUS system; PRI-MUS protocol was applied to identify suspicious lesions (i.e., PRIMUS score ≥ 3). All patients received targeted biopsies of any identified microUS and mpMRI lesions and complementary systematic biopsies. The proportion of patients upgraded to clinically significant PCa (defined as ISUP ≥ 2 cancer; csPCa) at confirmatory biopsies was determined, and the diagnostic performance of microUS and mpMRI were compared. Ninety-two patients had a suspicious MRI lesion classified PI-RADS 3, 4, and 5 in respectively 28, 16, and 18 patients. MicroUS identified 82 patients with suspicious lesions, classified as PRI-MUS 3, 4, and 5 in respectively 20, 50, and 12 patients, while 18 individuals had no lesions. Thirty-four patients were upgraded to ISUP ≥ 2 cancer and excluded from AS. MicroUS and mpMRI showed a sensitivity of 94.1% and 100%, and an NPV of 88.9% and 100%, respectively, in detecting ISUP ≥ 2 patients. A microUS-mandated protocol would have avoided confirmatory biopsies in 18 patients with no PRI-MUS ≥ 3 lesions at the cost of missing four upgraded patients. MicroUS and mpMRI represent valuable imaging modalities showing high sensitivity and NPV in detecting csPCa, thus allowing their use for event-triggered confirmatory biopsies in AS patients. MicroUS offers an alternative imaging modality to mpMRI for the identification and real-time targeting of suspicious lesions in AS patients.

MP73-01 DOES MRI OR PSA PREDICT BIOPSY OUTCOME AFTER FOCAL CRYOTHERAPY FOR PROSTATE CANCER?

You have accessJournal of UrologyCME1 Apr 2023MP73-01 DOES MRI OR PSA PREDICT BIOPSY OUTCOME AFTER FOCAL CRYOTHERAPY FOR PROSTATE CANCER? Wayne Brisbane, Mamdouh Aker, Lorna Kwan, Samantha Gonzalez, Alan Priester, Adam Kinnaird, Merdie Delfin, Ely Felker, Anthony Sisk, and David Kupperman Wayne BrisbaneWayne Brisbane More articles by this author , Mamdouh AkerMamdouh Aker More articles by this author , Lorna KwanLorna Kwan More articles by this author , Samantha GonzalezSamantha Gonzalez More articles by this author , Alan PriesterAlan Priester More articles by this author , Adam KinnairdAdam Kinnaird More articles by this author , Merdie DelfinMerdie Delfin More articles by this author , Ely FelkerEly Felker More articles by this author , Anthony SiskAnthony Sisk More articles by this author , and David KuppermanDavid Kupperman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003341.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We sought to determine the value of MRI and serum PSA levels in prediction of targeted biopsy results after partial gland ablation (PGA) of intermediate-risk prostate cancer (PCa) using cryotherapy (CRYO). METHODS: In a prospective, observational trial (NCT03503643), 143 men with unilateral PCa (all >GG2) were enrolled. PSA and MRI-guided biopsy (MRGB) was performed before and after PGA with CRYO. CRYO treatment was a 2-cycle freeze of the affected prostate part using argon gas delivered via transperineal needles under image guidance. Participants underwent MRI/US fusion biopsy at baseline to determine eligibility; at 6 months to determine technical success; and at 18 months. Fusion MRGB in follow-up at 6 and 18 months employed tracking technology (JAMA Open: 31509206). Successful ablation=absence of PCa >GG2 on MRGB. Effects on urinary and sexual function were studied via EPIC-CP. RESULTS: 95% of enrollees (136/143) completed f/u MRGB at 6 mo; 103 had a successful ablation (74%). Of the 103, 71 then had 18-mo f/u MRGB; success rate at 18 mo was 46/71 (65%); among 25 failures at 18 months, PCa was ipsilateral in 8, contralateral in 12, and bilateral in 5. Baseline MRI lesions (PIRADS >3) disappeared post-CRYO in 96/130 men (74%); PCa was found in 22/96 (23%) with no lesion and 11/34 (32%) with lesions (p=NS). In a mult-variate analysis, lesion diameter was the only parameter related to biopsy outcome. PSA levels were similar (p=NS) before and after CRYO in successful and failed treatments (FIGURE), as was PSA density. After CRYO, urinary function changed but little, or improved; overall sexual function decreased in 53/143 (39%), but only 10/143 men reported a severe decrement (>6 point decline). CONCLUSIONS: In the near to intermediate term, PGA with cryotherapy is a safe and moderately effective treatment of intermediate-risk PCa, when outcome is judged by MRGB. Neither PSA nor MRI, at baseline or during follow-up, appear reliable as indicators of post-treatment tissue findings. We postulate the treatment per se alters prostate anatomy and physiology in a manner that obscures a relationship between either test and pathological outcome. Source of Funding: This work was supported in part by the National Cancer Institute (R01CA195505), UCLA CTSI (UL1TR000124), the Jean Perkins Foundation, the Kent Kresa Family Foundation, and the Steven C. Gordon Family Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1034 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Wayne Brisbane More articles by this author Mamdouh Aker More articles by this author Lorna Kwan More articles by this author Samantha Gonzalez More articles by this author Alan Priester More articles by this author Adam Kinnaird More articles by this author Merdie Delfin More articles by this author Ely Felker More articles by this author Anthony Sisk More articles by this author David Kupperman More articles by this author Expand All Advertisement PDF downloadLoading ...

MP55-11 PSMA-GUIDED PROSTATE BIOPSY

You have accessJournal of UrologyCME1 Apr 2023MP55-11 PSMA-GUIDED PROSTATE BIOPSY David Kuppermann, Jeremie Calais, Elizabeth Tran, Samantha Gonzalez, Merdie Delfin, and Leonard Marks David KuppermannDavid Kuppermann More articles by this author , Jeremie CalaisJeremie Calais More articles by this author , Elizabeth TranElizabeth Tran More articles by this author , Samantha GonzalezSamantha Gonzalez More articles by this author , Merdie DelfinMerdie Delfin More articles by this author , and Leonard MarksLeonard Marks More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003308.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PSMA scanning is a most accurate method for detection of metastatic PCa. PSMA scanning may also reveal intra-prostatic cancer (PCa). Since MRI-guided biopsy (MRGB) may miss 15-20% of clinically-significant csPCa (≥GG2), we postulated that biopsy targeting PSMA foci in the prostate (PSMA-guided biopsy, PSMA-GB) might provide PCa detection in cases where MRGB failed. METHODS: 48 men with negative MRI-guided biopsy (MRGB), but continued suspicion of PCa (increased PSA density), underwent PSMA scanning within 6 months of MRGB. In the 23 with focal PSMA uptake in the prostate, a PSMA-GB was performed using PET/CT images instead of MR images for fusion with ultrasound. 4-8 biopsy cores were taken from each PSMA ‘hot spot’(Figure 1). Method of PSMA-GB was identical to MRGB, but employed US fusion with PET/CT instead of MRI, as detailed in the original case report (PMID: 28607878). Method of Ga-PSMA image acquisition via PET/CT scanning has been reported (PMID: 30920593). Contouring of PSMA foci within the prostate was via Profuse software by co-author J.C. Image fusion and trans-rectal targeted biopsy was via Artemis device (LSM). Detection rate of csPCa by PSMA-GB was primary endpoint. RESULTS: Among the 23 study patients, mean age=67 yrs (Range: 53-81); prostate volume=58.5cc (22.7-109.3); PSA=13.8 ng/ml (4.5- 34.8); PSA density=0.245 ng/ml/cc (0.073- 0.57). At first biopsy (MRGB), PIRADS score = 0-2 in 19 men and >3 in 4. PSMA-GB was successfully completed in all 23. Overall detection rate of csPCa was 15/23 (65.22%): GG2 in 6, GG3 in 6, GG4 in 2, and GG5 in 1. Median SUVmax (standardized uptake value) was 12.5 (5.8-28.7) in men whose PSMA hotspot revealed csPCa vs 5.8 (3.2-10.4) in men with negative PSMA-GB. Of 12 men whose PSMA focus was highly suspicious, i.e., Emmett’s Primary Score of 4 or 5 (PMID: 34373749 ), 11 had csPCa. CONCLUSIONS: Prostate biopsy, which targets PSMA ‘hot spots’ via PET/CT-US fusion, often leads to detection of csPCa missed by MRI-guided biopsy. Source of Funding: Jean Perkins Foundation; NCI-R01 CA 195505; and Department of Nuclear Medicine, UCLA. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e767 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Kuppermann More articles by this author Jeremie Calais More articles by this author Elizabeth Tran More articles by this author Samantha Gonzalez More articles by this author Merdie Delfin More articles by this author Leonard Marks More articles by this author Expand All Advertisement PDF downloadLoading ...

MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY?

You have accessJournal of UrologyCME1 Apr 2023MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY? Omri Schwarztuch Gildor, Anna Itshak, Yarden Fleischer, Ilan Leibovitch, Itay Sagy, and Itay Sternberg Omri Schwarztuch GildorOmri Schwarztuch Gildor More articles by this author , Anna ItshakAnna Itshak More articles by this author , Yarden FleischerYarden Fleischer More articles by this author , Ilan LeibovitchIlan Leibovitch More articles by this author , Itay SagyItay Sagy More articles by this author , and Itay SternbergItay Sternberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients with low-risk prostate cancer who are considering active surveillance (AS), it is common to repeat a biopsy within a year of diagnosis, as a confirmatory biopsy. The necessity of this biopsy was tested in the era before diagnosis based on MRI and showed a risk of 25-35% for reclassification in the confirmatory biopsy. Currently, most biopsies and new diagnoses of patients with a tumor suitable for AS are performed under the guidance of MRI. Our goal is to check the chance of reclassification when the diagnosis was made with an MRI-guided biopsy. METHODS: A retrospective review of all confirmatory biopsies performed at our center between 2015-2021. Data were collected about the diagnostic biopsy and the confirming biopsy based on the medical sheet and the pathological report. RESULTS: Of the 114 patients who underwent a confirmatory biopsy during the study period, 75 (65.8%) were diagnosed with a TRUS biopsy (group 1) and 39 (34.2%) with an MRI-guided biopsy (group 2). Patient age, PSA level, prostate size, PSA-D, and MRI findings were similar between groups. All confirmatory biopsies were performed with MRI guidance and included also systematic sampling. Reclassification to grade group (GG) ≥ 2 in the confirming biopsy was found in 31/75 (41.3%) and 15/39 (38.5%) patients in groups 1 and 2, respectively. This difference is not statistically significant (p=0.77). Similar reclassification rate (3/8, 37.5%) occurred in a subgroup (of group 2) of patients with previous negative systematic biopsy. In 9/75 (12.0%) and 4/39 (10.3%) patients in groups 1 and 2, respectively, the MRI-guided samples were found without significant prostate cancer and reclassification was made only because of the systematic samples. CONCLUSIONS: The risk of reclassification in a confirmatory biopsy continues to be significant even in the era of MRI-guided diagnosis of prostate cancer. We emphasize the importance of continuing to perform confirmatory biopsies and ensuring systematic sampling alongside sampling the region of interest. Source of Funding: Self funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e526 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Omri Schwarztuch Gildor More articles by this author Anna Itshak More articles by this author Yarden Fleischer More articles by this author Ilan Leibovitch More articles by this author Itay Sagy More articles by this author Itay Sternberg More articles by this author Expand All Advertisement PDF downloadLoading ...

V07-10 PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA)-TARGETED PROSTATE BIOPSY

You have accessJournal of UrologyCME1 Apr 2023V07-10 PROSTATE SPECIFIC MEMBRANE ANTIGEN (PSMA)-TARGETED PROSTATE BIOPSY David Kuppermann, Jeremie Calais, and Leonard Marks David KuppermannDavid Kuppermann More articles by this author , Jeremie CalaisJeremie Calais More articles by this author , and Leonard MarksLeonard Marks More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003288.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: MRI-guided biopsy (MRGB) has emerged as the de facto standard for the best accuracy in diagnosis of prostate cancer (PCa). However, MRI is imperfect, and both falsely positive and falsely negative results have been observed. A new method has been developed for diagnosis of PCa by using a new way to image PCa anywhere in the body. In the present video we illustrate how PSMA-targeted prostate biopsy can complement conventional MRGB. METHODS: PSMA PET scanning employs a radiotracer labeled with gallium 68 (Ga68) or fluor 18 (F18). When injected the radiotracer binds to the extracellular part of the PSMA molecule which sits on the surface of PCa cells. The bound molecule then becomes internalized into the cytoplasm of PCa cells, where it accumulates allowing visualization by PET scanning. A CT scan is then performed and overlayed for anatomic localization. The result is a visual representation of PCa, wherever it may be in the body including within the prostate. RESULTS: PSMA PET/CT detects lesions suspicious for clinically significant PCa (csPCa). The degree of suspicion is based on the pattern of the PSMA PET signal. When focal, the level of suspicion increases. When diffuse and faint, the level of suspicion decreases. The PSMA PET signal intensity is also quantified using a metric called Standardized Uptake Value (SUV). The suspicious lesions identified on PSMA PET/CT can be contoured, transferred onto an ultrasound (US) image fusion device, and used as targets for biopsy. At our institution the Artemis device is used, but the procedure is also applicable to other fusion devices. The prostate is imaged using US, anesthetized, scanned, and a 3D representation of the prostate is created for targeting and tracking of biopsy data. Next the PET/CT image, with a contoured region of interest, is fused with real-time US images of the prostate. Biopsy samples targeted to the PSMA avid spot are obtained in and around the lesion. If not obtained previously, systematic samples may also be obtained at this time. The tissue cores are submitted individually for pathologic review. The workflow is identical to that used in MRI-US fusion procedures. At this time PSMA guided biopsies are limited to cases where MRI is suspected of being falsely negative or where MRI is contraindicated. At our institution we have performed 21 PSMA-targeted biopsies in men whose MRGBs were negative, but PSA density remained elevated, of which 14 (66.67%) showed csPCa (≥ GG2). CONCLUSIONS: PSMA scanning and PSMA-targeted biopsy have brought on a disruptive innovation in the world of prostate cancer. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e599 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information David Kuppermann More articles by this author Jeremie Calais More articles by this author Leonard Marks More articles by this author Expand All Advertisement PDF downloadLoading ...

The Detection of Prostate Cancer with Magnetic Resonance Imaging-targeted Prostate Biopsies is Superior With the Transperineal vs the Transrectal Approach. A European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-institutional Study. Reply.

The Detection of Prostate Cancer with Magnetic Resonance Imaging-targeted Prostate Biopsies is Superior With the Transperineal vs the Transrectal Approach. A European Association of Urology-Young Academic Urologists Prostate Cancer Working Group Multi-institutional Study. Reply.

MP55-06 IS SYSTEMATIC BIOPSY STILL NEEDED IN MRI GUIDED PROSTATE BIOPSY? A MULTI-CENTRE ASIAN COHORT

You have accessJournal of UrologyCME1 Apr 2023MP55-06 IS SYSTEMATIC BIOPSY STILL NEEDED IN MRI GUIDED PROSTATE BIOPSY? A MULTI-CENTRE ASIAN COHORT Peter Ka-Fung Chiu, Alex Mok, Jeffrey J Leow, Kai Zhang, Chih Hung Chiang, Po Fan Hsieh, Wayne Lam, Woon Chau Tsang, Hoi Chak Chan, Yu Hua Fan, Tzu Ping Lin, Tetsu Hayashi, Kazumi Kamoi, Hiromi Uno, Jason Letran, Yao Zhu, Hai Feng Wan, Tsz Yeung Chan, Chao Yuan Huang, Gang Zhu, Hsi-Chin Wu, Edmund Chiong, Chi Fai Ng, and Sunao Shoji Peter Ka-Fung ChiuPeter Ka-Fung Chiu More articles by this author , Alex MokAlex Mok More articles by this author , Jeffrey J LeowJeffrey J Leow More articles by this author , Kai ZhangKai Zhang More articles by this author , Chih Hung ChiangChih Hung Chiang More articles by this author , Po Fan HsiehPo Fan Hsieh More articles by this author , Wayne LamWayne Lam More articles by this author , Woon Chau TsangWoon Chau Tsang More articles by this author , Hoi Chak ChanHoi Chak Chan More articles by this author , Yu Hua FanYu Hua Fan More articles by this author , Tzu Ping LinTzu Ping Lin More articles by this author , Tetsu HayashiTetsu Hayashi More articles by this author , Kazumi KamoiKazumi Kamoi More articles by this author , Hiromi UnoHiromi Uno More articles by this author , Jason LetranJason Letran More articles by this author , Yao ZhuYao Zhu More articles by this author , Hai Feng WanHai Feng Wan More articles by this author , Tsz Yeung ChanTsz Yeung Chan More articles by this author , Chao Yuan HuangChao Yuan Huang More articles by this author , Gang ZhuGang Zhu More articles by this author , Hsi-Chin WuHsi-Chin Wu More articles by this author , Edmund ChiongEdmund Chiong More articles by this author , Chi Fai NgChi Fai Ng More articles by this author , and Sunao ShojiSunao Shoji More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003308.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To evaluate the additional role of systematic biopsy in predicting clinically significant prostate cancer(csPCa) among Asian men with MRI-guided prostate biopsies performed. METHODS: The analyses were done in 5240 Asian men in a multicenter MRI-guided biopsy database of 21 Asian centers in Hong Kong, Shanghai, Beijing, Taiwan, Singapore, Japan, and the Philippines. Each men underwent MRI-targeted and systematic biopsy. The role of systematic biopsy in various PI-RADS and PSA levels in predicting clinically significant prostate cancer(ISUP>=2) was evaluated. RESULTS: 3080 men with prostate volume and PI-RADS score available, and systematic and targeted biopsies reported separately, were included. 4.9%, 42.6%, 35.8% and 14.7% patients had highest PI-RADS score 2, 3, 4 and 5, respectively. The median PSA, PSA density, targeted cores, and systematic cores were 8.2, 0.19, 3 and 12 respectively. 54.9% had PCa and 41.1% had csPCa. csPCa was diagnosed in 9.7%, 22.5%, 57.2% and 78.1% of men with PI-RADS score 2,3,4 and 5, respectively. csPCa diagnosed only on systematic biopsy but not on targeted biopsy is shown in Table 1. CONCLUSIONS: csPCa on additional systematic biopsy was only 5.6% in men with PSA density<0.15. Additional systematic biopsy has limited role in men with highest PI-RADS score of 2 or 3, and PI-RADS 4 with PSA density<0.15. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e765 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Peter Ka-Fung Chiu More articles by this author Alex Mok More articles by this author Jeffrey J Leow More articles by this author Kai Zhang More articles by this author Chih Hung Chiang More articles by this author Po Fan Hsieh More articles by this author Wayne Lam More articles by this author Woon Chau Tsang More articles by this author Hoi Chak Chan More articles by this author Yu Hua Fan More articles by this author Tzu Ping Lin More articles by this author Tetsu Hayashi More articles by this author Kazumi Kamoi More articles by this author Hiromi Uno More articles by this author Jason Letran More articles by this author Yao Zhu More articles by this author Hai Feng Wan More articles by this author Tsz Yeung Chan More articles by this author Chao Yuan Huang More articles by this author Gang Zhu More articles by this author Hsi-Chin Wu More articles by this author Edmund Chiong More articles by this author Chi Fai Ng More articles by this author Sunao Shoji More articles by this author Expand All Advertisement PDF downloadLoading ...

Ultrasound-guided breast biopsy using an adapted automated cone-based ultrasound scanner: a feasibility study.

Among available breast biopsy techniques, ultrasound (US)-guided biopsy is preferable because it is relatively inexpensive and provides live imaging feedback. The availability of magnetic resonance imaging (MRI)-3D US image fusion would facilitate US-guided biopsy even for US occult lesions to reduce the need for expensive and time-consuming MRI-guided biopsy. In this paper, we propose a novel Automated Cone-based Breast Ultrasound Scanning and Biopsy System (ACBUS-BS) to scan and biopsy breasts of women in prone position. It is based on a previously developed system, called ACBUS, that facilitates MRI-3D US image fusion imaging of the breast employing a conical container filled with a coupling medium. The purpose of this study was to introduce the ABCUS-BS system and demonstrate its feasibility for biopsy of US occult lesions. The biopsy procedure with the ACBUS-BS comprises four steps: target localization, positioning, preparation, and biopsy. The biopsy outcome can be impacted by 5 types of errors: due to lesion segmentation, MRI-3D US registration, navigation, lesion tracking during repositioning, and US inaccuracy (due to sound speed difference between the sample and the one used for image reconstruction). For the quantification, we use a soft custom-made polyvinyl alcohol phantom (PVA) containing 8 lesions (3 US-occult and 5 US-visible lesions of 10 mm in diameter) and a commercial breast mimicking phantom with a median stiffness of 7.6 kPa and 28 kPa, respectively. Errors of all types were quantified using the custom-made phantom. The error due to lesion tracking was also quantified with the commercial phantom. Finally, the technology was validated by biopsying the custom-made phantom and comparing the size of the biopsied material to the original lesion size. The average size of the 10-mm-sized lesions in the biopsy specimen was 7.00 ± 0.92 mm (6.33 ± 1.16 mm for US occult lesions, and 7.40 ± 0.55 mm for US-visible lesions). For the PVA phantom, the errors due to registration, navigation, lesion tracking during repositioning, and US inaccuracy were 1.33 mm, 0.30 mm, 2.12 mm, and 0.55 mm. The total error was 4.01 mm. For the commercial phantom, the error due to lesion tracking was estimated at 1.10 mm, and the total error was 4.11 mm. Given these results, the system is expected to successfully biopsy lesions larger than 8.22 mm in diameter. Patient studies will have to be carried out to confirm this in vivo. The ACBUS-BS facilitates US-guided biopsy of lesions detected in pre-MRI and therefore might offer a low-cost alternative to MRI-guided biopsy. We demonstrated the feasibility of the approach by successfully taking biopsies of 5 US-visible and 3 US-occult lesions embedded in a soft breast-shaped phantom. This article is protected by copyright. All rights reserved.

DEPROMP Trial: the additive value of PSMA-PET/CT-guided biopsy for prostate cancer management in biopsy naïve men—study protocol for a randomized trial

BackgroundThe primary objective is to determine the proportion of men with suspected prostate cancer (PCA) in whom the management plans are changed by additive gallium-68 prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA-PET/CT) guided prostate biopsy (PET-TB) in combination with standard of care (SOC) using systematic (SB) and multiparametric magnetic resonance imaging-guided biopsy (MR-TB) compared with SOC alone. The major secondary objectives are to determine the additive value of the combined approach of SB + MR-TB + PET-TB (PET/MR-TB) for detecting clinically significant PCA (csPCA) compared to SOC; to determine sensitivity, specificity, positive and negative predictive value and diagnostic accuracy of imaging techniques, respective imaging classification systems, and each biopsy method; and to compare preoperatively defined tumor burden and biomarker expression and pathological tumor extent in prostate specimens.MethodsThe DEPROMP study is a prospective, open-label, interventional investigator-initiated trial. Risk stratification and management plans after PET/MR-TB are conducted randomized and blinded by different evaluation teams of experienced urologists based on histopathological analysis and imaging information: one including all results of the PET/MR-TB and one excluding the additional information gained by PSMA-PET/CT guided biopsy. The power calculation was centered on pilot data, and we will recruit up to 230 biopsy-naïve men who will undergo PET/MR-TB for suspected PCA. Conduct and reporting of MRI and PSMA-PET/CT will be performed in a blinded fashion.DiscussionThe DEPROMP Trial will be the first to evaluate the clinically relevant effects of the use of PSMA-PET/CT in patients with suspected PCA compared to current SOC. The study will provide prospective data to determine the diagnostic yields of additional PET-TB in men with suspected PCA and the impact on treatment plans in terms of intra- and intermodal changes. The results will allow a comparative analysis of risk stratification by each biopsy method, including a performance analysis of the corresponding rating systems. This will reveal potential intermethod and pre- and postoperative discordances of tumor stage and grading, providing the opportunity to critically assess the need for multiple biopsies.Trial registrationGerman Clinical Study Register DRKS 00024134. Registered on 26 January 2021.