ABSTRACT
BACKGROUND: This study investigates the use of biparametric magnetic resonance imaging (bpMRI) as primary opportunistic screening for prostate cancer (PCa) without using a prostate-specific antigen (PSA) cut-off. OBJECTIVE: The primary endpoint was to assess the efforts and effectiveness of identifying 20 participants with clinically significant prostate cancer (csPCa) using bpMRI. DESIGN, SETTING, AND PARTICIPANTS: Biopsy-naïve men aged over 45 yr were included. All participants underwent 3 Tesla bpMRI, PSA, and digital rectal examination (DRE). Targeted-only biopsy was performed in participants with Prostate Imaging Reporting and Data System (PI-RADS) ≥3. Men with negative bpMRI but suspicious DRE or elevated PSA/PSA density had template biopsies. Preintended protocol adjustments were made after an interim analysis for PI-RADS 3 lesions: no biopsy and follow-up MRI after 6 mo and biopsy only if lesions persisted or upgraded. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Biopsy results underwent a comparison using Fisher's exact test and univariable logistic regression to identify prognostic factors for positive biopsy. RESULTS AND LIMITATIONS: A total of 229 men were enrolled in this study, of whom 79 underwent biopsy. Among these men, 77 displayed suspicious PI-RADS lesions. PCa was detected in 29 participants (12.7%), of whom 21 had csPCa (9.2%). Biparametric MRI detected 21 csPCa cases, while PSA and DRE would have missed 38.1%. Protocol adjustment led to a 54.6% biopsy reduction in PI-RADS 3 lesions. Overall, in this cohort of men with a median PSA value of 1.26 ng/ml, 10.9 bpMRI scans were needed to identify one participant with csPCa. A major limitation of the study is the lack of a control cohort undergoing systematic biopsies. CONCLUSIONS: Opportunistic screening utilising bpMRI as a primary tool has higher sensitivity in detecting csPCa than classical screening methods. PATIENT SUMMARY: Screening with biparametric magnetic resonance imaging (bpMRI) and targeted biopsy identified clinically significant prostate cancer in every 11th man, regardless of the prostate-specific antigen (PSA) levels. Preselecting patients based on PSA >1 ng/ml and a positive family history of prostate cancer, as well as other potential blood tests may further improve the effectiveness of bpMRI in this setting.
ABSTRACT
BACKGROUND: It has been shown that the Stockholm3 test decreases overdetection of prostate cancer (PCa) while retaining the ability to detect clinically significant PCa (csPCa) in a Swedish population. However, the test includes potentially population-specific testing of single-nucleotide polymorphisms and has yet not been validated outside Scandinavia. OBJECTIVE: To assess the performance of the Stockholm3 test in discriminating csPCa in a Central European cohort undergoing prostate biopsy (PBx). DESIGN, SETTING, AND PARTICIPANTS: This prospective multicenter validation study was conducted from August 2020 to September 2022 at two centers in Switzerland and one center in Germany. The study involved 342 men undiagnosed with PCa who were scheduled for PBx after prostate-specific antigen (PSA) testing and subsequent magnetic resonance imaging (MRI) of the prostate. Before PBx, participants had a blood sample taken for Stockholm3 testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the accuracy of the Stockholm3 test in detecting csPCa (International Society of Urological Pathology grade group [GG] ≥2) according to the area under the receiver operating characteristic curve (AUC), sensitivity, and specificity, and the clinical consequences of using the model. RESULTS AND LIMITATIONS: The Stockholm3 test with a cutoff of 11% for csPCa detection had sensitivity of 92.3% (95% confidence interval [CI] 86.9-95.9%), specificity of 32.6% (95% CI 26.0-39.8%), a positive predictive value of 53.2% (95% CI 47.0-59.2%), and a negative predictive value of 83.6% (95% CI 73-91.2%). It showed superior discrimination for csPCa (AUC 0.77, 95% CI 0.72-0.82) in comparison to PSA (AUC 0.66, 95% CI 0.61-0.72; p < 0.001). Using a Stockholm3 cutoff of 11%, PBx could have been omitted for 73 men (21.0%), and 12/154 (8%) csPCa and 2/72 (2.8%) GG >2 cases would have been missed. Limitations include population selection bias. CONCLUSIONS: Our results show favorable clinical outcomes for the blood-based Stockholm3 biomarker test in a Central European patient cohort. PATIENT SUMMARY: The Stockholm3 blood test shows better accuracy in predicting prostate cancer than the more common PSA (prostate-specific antigen) test.
ABSTRACT
OBJECTIVES: A modern baseline assessment of erectile dysfunction (ED) should be individualized, reliable, noninvasive and cost-efficient. Appraisal based on the patient's self-evaluation may be the method of choice. METHODS: Using a self-report method, 63 consecutive ED patients were prospectively investigated. Semiquantitative parameters on 7 criteria were assessed, and an intracavernous injection test with alprostadil was performed. Performances of self-reporting and intracavernous testing in predicting penetrative ability were compared. RESULTS: Twenty-three (37%) men had erection insufficient for penetration even with manual assistance, 26 (41%) men needed manual assistance and 14 (22%) could penetrate without manual assistance but erection was not sufficient for satisfaction. In addition to impaired penetrative ability, 6 criteria (intercourse frequency, patient's and partner's satisfaction, penile rigidity, duration of erection and need for extra stimulation) deteriorated over time (p < 0.006). Patient self-evaluation criteria such as intercourse per week, patient satisfaction, penile rigidity, duration of erection and time between consultation and last satisfactory intercourse showed discriminating differences in accordance with the 3 subgroups of penetrative ability (p < 0.02). Intracavernous testing could not reproduce the degree of erectile deficit as experienced during intercourse (p = 0.21). In a logistic regression model, criteria best characterizing penetrative ability were penile rigidity, time between consultation and last unsuccessful intercourse, and degree of satisfaction (p < 0.0001). CONCLUSIONS: The patient's self-evaluation by semiquantitative parameters on criteria characterizing sexual erections better predicts the penetrative ability than the response to an intracavernous injection. These criteria quantify both the objective degree of ED and the patient's apprehension. Consequently, patients may undergo immediate treatment without further testing.
