Project description:ObjectiveTo report outcomes of magnetic resonance imaging (MRI)-ultrasound fusion-targeted biopsy (MRF-TB) and 12-core systematic biopsy (SB) over a 26-month period in men with prior negative prostate biopsy.Materials and methodsBetween June 2012 and August 2014, 210 men presenting to our institution for prostate biopsy with ≥1 prior negative biopsy underwent multiparametric MRI followed by MRF-TB and SB and were entered into a prospective database. Clinical characteristics, maximum mpMRI suspicion scores (mSS), and biopsy results were queried from the database, and the detection rates of Gleason ≥7 prostate cancer (PCa) and overall PCa were compared between biopsy techniques using McNemar's test.ResultsForty seven (29%) of 161 men meeting inclusion criteria (mean age, 65 ± 8 years; mean prostate-specific antigen, 8.9 ± 8.9) were found to have PCa. MRF-TB and SB had overall cancer detection rates (CDRs) of 21.7% and 18.6% (P = .36), respectively, and CDR for Gleason score (GS) ≥7 disease of 14.9% and 9.3% (P = .02), respectively. Of 26 men with GS ≥7 disease, MRF-TB detected 24 (92.3%) whereas SB detected 15 (57.7%; P < .01). Using UCSF-CAPRA criteria, only 1 man was restratified from low risk to higher risk based on SB results compared to MRF-TB alone. Among men with mSS <4, 72% of detected cancers were low risk by UCSF-CAPRA criteria.ConclusionIn men with previous negative biopsies and persistent suspicion of PCa, SB contributes little to the detection of GS ≥7 disease by MRF-TB, and avoidance of SB bears consideration. Based on the low likelihood of detecting GS ≥7 cancer and overall low-risk features of PCa in men with mSS <4, limiting biopsy to men with mSS ≥4 warrants further investigation.
Project description:BackgroundScreening for prostate cancer is burdened by a high rate of overdiagnosis. The most appropriate algorithm for population-based screening is unknown.MethodsWe invited 37,887 men who were 50 to 60 years of age to undergo regular prostate-specific antigen (PSA) screening. Participants with a PSA level of 3 ng per milliliter or higher underwent magnetic resonance imaging (MRI) of the prostate; one third of the participants were randomly assigned to a reference group that underwent systematic biopsy as well as targeted biopsy of suspicious lesions shown on MRI. The remaining participants were assigned to the experimental group and underwent MRI-targeted biopsy only. The primary outcome was clinically insignificant prostate cancer, defined as a Gleason score of 3+3. The secondary outcome was clinically significant prostate cancer, defined as a Gleason score of at least 3+4. Safety was also assessed.ResultsOf the men who were invited to undergo screening, 17,980 (47%) participated in the trial. A total of 66 of the 11,986 participants in the experimental group (0.6%) received a diagnosis of clinically insignificant prostate cancer, as compared with 72 of 5994 participants (1.2%) in the reference group, a difference of -0.7 percentage points (95% confidence interval [CI], -1.0 to -0.4; relative risk, 0.46; 95% CI, 0.33 to 0.64; P<0.001). The relative risk of clinically significant prostate cancer in the experimental group as compared with the reference group was 0.81 (95% CI, 0.60 to 1.1). Clinically significant cancer that was detected only by systematic biopsy was diagnosed in 10 participants in the reference group; all cases were of intermediate risk and involved mainly low-volume disease that was managed with active surveillance. Serious adverse events were rare (<0.1%) in the two groups.ConclusionsThe avoidance of systematic biopsy in favor of MRI-directed targeted biopsy for screening and early detection in persons with elevated PSA levels reduced the risk of overdiagnosis by half at the cost of delaying detection of intermediate-risk tumors in a small proportion of patients. (Funded by Karin and Christer Johansson's Foundation and others; GÖTEBORG-2 ISRCTN Registry number, ISRCTN94604465.).
Project description:PurposeThis study was designed to identify a useful clinical parameter or model for prostate biopsy in surgery-indicated benign prostate hyperplasia (BPH) patients with elevated PSA levels and negative multiparametric prostate magnetic resonance imaging (MRI) results.Patients and methodsWe retrospectively analyzed clinical and pathological data from patients who were diagnosed with BPH and admitted to the inpatient department for surgery between January 2010 and September 2020. Clinical data, including age, prostate specific antigen (PSA) level, F/T PSA ratio, prostate volume, and PSA density (PSAD), were used for comprehensive analysis. Univariate and multivariate logistic regression analyses were performed to develop a predictive model. Receiver operating characteristic (ROC) analysis and decision curve analysis (DCA) were performed to assess the diagnostic value of the predictive model, PSA concentration, F/T PSA ratio and PSAD.ResultsA total of 318 patients were included in the study, 8.2% (26/318) of whom were histologically diagnosed with prostate cancer (PCa). Univariate and multivariate logistic regression analyses revealed that PSAD was the only independent predictor of PCa biopsy. ROC curve analysis of PCa detection revealed a larger area under the curve (AUC) for the predictive model (AUC 0.855) and for PSAD (AUC 0.848) than for PSA (AUC 0.722) or the F/T PSA ratio (AUC 0.635). DCA demonstrated that the optimal strategy would be to restrict biopsies to men with a PSAD of 0.30 ng/ml/cm3.ConclusionsOur study suggested that for BPH patients with surgical indications who present with PSA abnormalities and negative imaging findings, the use of a new PSAD threshold of 0.30 ng/ml/cm3 could facilitate convenient and sound biopsy decisions. This approach could reduce the complications and length of hospital stay associated with biopsies and reduce hospital costs.
Project description:PurposeA pre-biopsy decision aid is needed to counsel men with a clinical suspicion for clinically significant prostate cancer (csPCa), despite normal prostate magnetic resonance imaging (MRI).MethodsA risk calculator (RC) for csPCa (International Society of Urological Pathology grade group (ISUP) ⩾ 2) presence in men with a negative-MRI (Prostate Imaging-Reporting and Data System (PI-RADS) ⩽ 2) was developed, and its performance was compared with RCs of the European Randomized Study of Screening for Prostate Cancer (ERSPC), Prostate Biopsy Collaborative Group (PBCG), and Prospective Loyola University mpMRI (PLUM). All biopsy-naïve and prior negative biopsy men with a negative-MRI followed by systematic prostate biopsy were included from October 2015 to September 2021. The RC was developed using multivariable logistic regression with the following parameters: age (years), family history of PCa (first- or second-degree family member), ancestry (African Caribbean/other), digital rectal exam (benign/malignant), MRI field strength (1.5/3.0 Tesla), prior negative biopsy status, and prostate-specific antigen (PSA) density (ng/ml/cc). Performance of RCs was compared using receiver operating characteristic (ROC) curve analysis.ResultsA total of 232 men were included for analysis, of which 18.1% had csPCa. Parameters associated with csPCa were family history of PCa (p < 0.0001), African Caribbean ancestry (p = 0.005), PSA density (p = 0.002), prior negative biopsy (p = 0.06), and age at biopsy (p = 0.157). The area under the curve (AUC) of the developed RC was 0.76 (95% CI 0.68-0.85). This was significantly better than the RCs of the ERSPC (AUC: 0.59; p = 0.001) and PBCG (AUC: 0.60; p = 0.002), yet similar to PLUM (AUC: 0.69; p = 0.09).ConclusionThe developed RC (Prostate Biopsy Cohort Amsterdam ('PROBA' RC), integrated predictors for csPCa at prostate biopsy in negative-MRI men and outperformed other widely used RCs. These findings require external validation before introduction in daily practice.
Project description:ObjectiveTo compare the diagnostic outcomes of the current approach of transrectal ultrasound (TRUS)-guided biopsy in men with suspected prostate cancer to an alternative approach using multiparametric MRI (mpMRI), followed by MRI-targeted biopsy if positive.DesignClinical decision analysis was used to synthesise data from recently emerging evidence in a format that is relevant for clinical decision making.PopulationA hypothetical cohort of 1000 men with suspected prostate cancer.InterventionsmpMRI and, if positive, MRI-targeted biopsy compared with TRUS-guided biopsy in all men.Outcome measuresWe report the number of men expected to undergo a biopsy as well as the numbers of correctly identified patients with or without prostate cancer. A probabilistic sensitivity analysis was carried out using Monte Carlo simulation to explore the impact of statistical uncertainty in the diagnostic parameters.ResultsIn 1000 men, mpMRI followed by MRI-targeted biopsy 'clinically dominates' TRUS-guided biopsy as it results in fewer expected biopsies (600 vs 1000), more men being correctly identified as having clinically significant cancer (320 vs 250), and fewer men being falsely identified (20 vs 50). The mpMRI-based strategy dominated TRUS-guided biopsy in 86% of the simulations in the probabilistic sensitivity analysis.ConclusionsOur analysis suggests that mpMRI followed by MRI-targeted biopsy is likely to result in fewer and better biopsies than TRUS-guided biopsy. Future research in prostate cancer should focus on providing precise estimates of key diagnostic parameters.
Project description:ObjectivesTo evaluate the ability of magnetic resonance imaging (MRI)-targeted biopsy combined with systematic biopsy (MRI-biopsy) to reduce negative biopsies and detect clinically significant prostate cancer compared to systematic biopsy (SB) alone in the confirmatory biopsy setting using matched cohorts.Patients and methodsPatients were identified from an active surveillance database who had a previously positive transrectal ultrasonography-guided SB followed by a confirmatory biopsy at a single institution between 2006 and 2019. Patients were divided into two cohorts based on confirmatory biopsy technique: SB alone or MRI-biopsy (which included MRI-targeted and systematic biopsies). Cohorts were then matched on age, prostate-specific antigen (PSA) level, number of positive cores on initial biopsy and initial biopsy Gleason grade group (GG). Logistic regression was performed to identify associations with confirmatory biopsy upgrading.ResultsAfter matching, 514 patients were identified (257 per cohort). PSA, prostate volume and PSA density prior to initial biopsy, in addition to total number of initial biopsy positive cores and GG, were similar between the matched cohorts. After confirmatory biopsy, 118/257 patients (45.9%) in the MRI-biopsy cohort were upgraded compared to 46/257 patients (17.9%) in the SB cohort (P < 0.001). The rate of negative confirmatory biopsy was 32/257 (12.5%) compared to 97/257 (37.7%) in the MRI-biopsy and SB cohorts, respectively (P < 0.001). Confirmatory MRI-biopsy was associated with greater odds of confirmatory biopsy upgrade from GG 1 to ≥GG 2 compared to SB alone (odds ratio 3.62, 95% confidence interval 1.97-6.63; P < 0.001).ConclusionThe addition of MRI-targeted biopsies to SB in the confirmatory biopsy setting among men with previously detected prostate cancer resulted in fewer negative confirmatory biopsies and detection of more clinically significant prostate cancer compared to SB alone.
Project description:The role of magnetic resonance imaging (MRI) prior to biopsy in the diagnosis of prostate cancer in biopsy-naïve patients has been strengthened by recent developments such as the PIRADS V2 criteria, which cover acquisition, interpretation, and reporting for clinical practice and data collection for research. Important questions on the role of prostate MRI remain: can MRI be used as a triage test before first biopsy series? Can it be used to avoid the use of systematic biopsies (SB) and instead use only targeted biopsies (TB) to MRI-suspicious lesions? Studies to evaluate image guided TB compared to SB have started to accumulate. Objectives of these studies should be to reduce the detection of clinically insignificant disease, to maximize the detection of clinically significant cancer (CSC), to better assess disease size, grade and location. Accurate diagnosis will allow the choice of the most appropriate treatments options, minimising side effects and reducing overtreatment. Study results on MRI-TB detection rates are promising however some limitations should be considered. The majority of published and ongoing studies have been performed at expert centres, in order to demonstrate the optimal performance of MRI. Then, the validation of this strategy in less specialised institutions will be necessary before incorporating recommendations in international guidelines. It necessitates training for radiologists and urologists to perform and read MRI and MRI-targeted biopsy through education programs and standardization tools. All these advances will be consolidated with expected genetic screening tools to improve the detection of aggressive cancer.
Project description:BackgroundMultiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited.MethodsIn a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer.ResultsA total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001).ConclusionsThe use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).
Project description:PurposeThe use of MRI-targeted biopsies has led to lower detection of Gleason Grade Group 1 (GG1) prostate cancer and increased detection of GG2 disease. Although this finding is generally attributed to improved sensitivity and specificity of MRI for aggressive cancers, it might also be explained by grade inflation. Our objective was to determine the likelihood of definitive treatment and risk of post-treatment recurrence for patients with GG2 cancer diagnosed using targeted biopsies relative to men with GG1 cancer diagnosed using systematic biopsies.MethodsWe performed a retrospective study on a large tertiary centre registry (HUS Acamedic Datalake) to retrieve data on prostate cancer diagnosis, treatment, and cancer recurrence. We included patients with either GG1 with systematic biopsies (3317 men) or GG2 with targeted biopsies (554 men) from 1993 to 2019. We assessed the risk of curative treatment and recurrence after treatment. Kaplan-Meier survival curves were computed to assess treatment- and recurrence-free survival. Cox proportional hazards regression analysis was performed to assess the risk of posttreatment recurrence.ResultsPatients with systematic biopsy detected GG1 cancer had a significantly longer median time-to-treatment (31 months) than those with targeted biopsy detected GG2 cancer (4 months, p<0.0001). The risk of recurrence after curative treatment was similar between groups with the upper bound of 95% CI, excluding an important difference (HR: 0.94, 95% CI [0.71-1.25], p=0.7).ConclusionGG2 cancers detected by MRI-targeted biopsy are treated more aggressively than GG1 cancers detected by systematic biopsy, despite having similar oncologic risk. To prevent further overtreatment related to the MRI pathway, treatment guidelines from the pre-MRI era need to be updated to consider changes in the diagnostic pathway.
Project description:The objective of our study is to examine the correlation between PSA density (PSAd) at the time of diagnosis with PSA velocity (PSAV), PSA doubling time and tumour progression, on repeat biopsy, in men with prostate cancer on active surveillance. Data from 102 patients with clinically localized prostate cancer on active surveillance in the period between 1992 and 2007, who had the necessary parameters available, were collected. PSAd was calculated and correlated with PSAV, PSA doubling time (PSADT), Gleason score at diagnosis and local progression on repeated biopsies. PSAV was 0.64 and 1.31 ng ml(-1) per year (P = 0.02), PSADT of 192 and 113 months (P = 0.4) for PSAd below and above 0.15, respectively. The rate of detecting high Gleason score (≥ 7) at diagnosis was 6 and 23% for PSAd below and above 0.15, respectively. A total of 101 patients underwent at least a second biopsy and the incidence of upgrading was 10 and 31% for PSAd below and above 0.15, respectively (P = 0.001). Although low PSAd is an accepted measure for suggesting insignificant prostate cancer, our study expands its role to indicate that PSAd < 0.15 may be an additional clinical parameter that may suggest indolent disease, as measured by future PSAV and repeat biopsy over time.