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Background and objective: Advances in for magnetic resonance imaging (MRI)-guided transperineal biopsy (TPBx) techniques have facilitated outpatient prostate biopsies under local anaesthesia to lower postbiopsy infection rates. However, there is debate regarding antibiotic prophylaxis because of concerns regarding antibiotic resistance and interactions. Our objective was to assess the transition from office-based transrectal biopsy to TPBx performed under local anaesthesia without antibiotic prophylaxis despite potential risk factors for infectious complications. Methods: We conducted a prospective assessment of 665 men undergoing office-based MRI-guided TPBx. The primary outcome was the rate of urosepsis or febrile urinary tract infections requiring hospitalisation and/or antibiotics within 2 wk after biopsy. Secondary outcomes included patient-reported procedure tolerability and the prostate cancer detection rate. Key findings and limitations: TPBx using a median of nine cores per patient (range 4–15) detected prostate cancer in 534/665 men (80%). Only four men (0.6%) were hospitalised for suspected postbiopsy infection; no patient experienced urosepsis. The TPBx procedure was well tolerated, with low pain scores (median Visual Analogue Scale score of 2, interquartile range [IQR] 1–3) and positive patient ratings (median rating 1 [no problem], IQR 1–2). Limitations include the single-centre analysis and lack of randomisation for antibiotic prophylaxis. Conclusions and clinical implications: An office-based TPBx strategy under local anaesthesia without antibiotic prophylaxis is well tolerated and has a very low risk of side effects. This approach should be considered as the standard of care. Further studies may determine if a subgroup of predisposed men could benefit from antibiotic prophylaxis. Patient summary: For prostate biopsy the sampling needle can be inserted through the rectum or through the perineum, which is the skin between the rectum and the scrotum

Background: The B-cell lymphoma-extra-large (Bcl-XL) protein plays an important role in cancer cells’ resistance to apoptosis. Pre-clinical studies have shown that vaccination with Bcl-XL-derived peptides can induce tumor-specific T cell responses that may lead to the elimination of cancer cells. Furthermore, pre-clinical studies of the novel adjuvant CAF®09b have shown that intraperitoneal (IP) injections of this adjuvant can improve the activation of the immune system. In this study, patients with hormone-sensitive prostate cancer (PC) received a vaccine consisting of Bcl-XL-peptide with CAF®09b as an adjuvant. The primary aim was to evaluate the tolerability and safety of IP and intramuscular (IM) administration, determine the optimal route of administration, and characterize vaccine immunogenicity. Patients and methods: Twenty patients were included. A total of six vaccinations were scheduled: in Group A (IM to IP injections), ten patients received three vaccines IM biweekly; after a three-week pause, patients then received three vaccines IP biweekly. In Group B (IP to IM injections), ten patients received IP vaccines first, followed by IM under a similar vaccination schedule. Safety was assessed by logging and evaluating adverse events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE v. 4.0). Vaccines-induced immune responses were analyzed by Enzyme-Linked Immunospot and flow cytometry. Results: No serious AEs were reported. Although an increase in T cell response against the Bcl-XL-peptide was found in all patients, a larger proportion of patients in group B demonstrated earlier and stronger immune responses to the vaccine compared to patients in group A. Further, we demonstrated vaccine-induced immunity towards patient-specific CD4, and CD8 T cell epitopes embedded in Bcl-XL-peptide and an increase in CD4 and CD8 T cell activation markers CD107a and CD137 following vaccination.

The majority of neoantigens arise from unique mutations that are not shared between individual patients, making neoantigen-directed immunotherapy a fully personalized treatment approach. Novel technical advances in next-generation sequencing of tumor samples and artificial intelligence (AI) allow fast and systematic prediction of tumor neoantigens. This study investigates feasibility, safety, immunity, and anti-tumor potential of the personalized peptide-based neoantigen vaccine, EVX-01, including the novel CD8+ T-cell inducing adjuvant, CAF®09b, in patients with metastatic melanoma (NTC03715985). The AI platform PIONEERTM was used for identification of tumor-derived neoantigens to be included in a peptide-based personalized therapeutic cancer vaccine. EVX-01 immunotherapy consisted of 6 administrations with 5–10 PIONEERTM-predicted neoantigens as synthetic peptides combined with the novel liposome-based Cationic Adjuvant Formulation 09b (CAF®09b) to strengthen T-cell responses. EVX-01 was combined with immune checkpoint inhibitors to augment the activity of EVX-01-induced immune responses. The primary endpoint was safety, exploratory endpoints included feasibility, immunologic and objective responses. This interim analysis reports the results from the first dose-level cohort of five patients. We documented a short vaccine manufacturing time of 48–55 days which enabled the initiation of EVX-01 treatment within 60 days from baseline biopsy. No severe adverse events were observed. EVX-01 elicited long-lasting EVX-01-specific T-cell responses in all patients. Competitive manufacturing time was demonstrated. EVX-01 was shown to be safe and able to elicit immune responses targeting tumor neoantigens with encouraging early indications of a clinical and meaningful antitumor efficacy, warranting further study.

This review looks at highlights of the development in ultrasound, ranging from interventional ultrasound and Doppler to the newest techniques like contrast-enhanced ultrasound and elastography, and gives reference to some of the valuable articles in Acta Radiologica. Ultrasound equipment is now available in any size and for any purpose, ranging from handheld devices to high-end devices, and the scientific societies include ultrasound professionals of all disciplines publishing guidelines and recommendations. Interventional ultrasound is expanding the field of use of ultrasound-guided interventions into nearly all specialties of medicine, from ultrasound guidance in minimally invasive robotic procedures to simple ultrasound-guided punctures performed by general practitioners. Each medical specialty is urged to define minimum requirements for equipment, education, training, and maintenance of skills, also for medical students. The clinical application of contrast-enhanced ultrasound and elastography is a topic often seen in current research settings.

Importance: Multiparametric magnetic resonance imaging (MRI) enhances detection and risk stratification for significant prostate cancer but is time-consuming (approximately 40 minutes) and expensive. Rapid and simpler (approximately 15-minute) biparametric MRI (bpMRI) using fewer scan sequences could be implemented as a prostate MRI triage test on a larger scale before performing biopsies.Objectives: To assess the diagnostic accuracy and negative predictive value (NPV) of a novel bpMRI method in biopsy-naive men in detecting and ruling out significant prostate cancer in confirmatory biopsies.Design, Setting, and Participants: A single-institutional, paired, prospective cohort study of biopsy-naive men with clinical suspicion of prostate cancer from November 1, 2015, to June 15, 2017.Interventions: All patients underwent bpMRI (T2-weighted and diffusion-weighted imaging) followed by standard transrectal ultrasound-guided biopsies (all men) and targeted biopsies of men with suspicious bpMRI findings.Main Outcomes and Measures: Suspicion grades of bpMRI, biopsy results, and NPV of bpMRI were evaluated for detection of or ruling out significant prostate cancer (Gleason score ≥4 + 3 or maximum cancerous core length >50% for Gleason score 3 + 4). We compared the diagnostic performance of standard biopsies in all men vs standard plus targeted (combined) biopsies restricted to men with suspicious bpMRI findings. The reference standard was combined biopsy results from all men.Results: A total of 1020 men were enrolled, with a median age of 67 years (interquartile range, 61-71 years) and a median prostate-specific antigen level of 8.0 ng/mL (interquartile range, 5.7-13.0 ng/mL). Combined biopsies detected any and significant prostate cancer in 655 of 1020 men (64%) and 404 of 1020 men (40%), respectively. Restricting combined biopsies to men with suspicious bpMRI findings meant 305 of 1020 men (30%) with low-suspicious bpMRIs could avo

Background Multiparametric magnetic resonance imaging (mpMRI) can improve detection of clinically significant prostate cancer (csPCa). Purpose To compare mpMRI score subgroups to systematic transrectal ultrasound-guided biopsies (TRUSbx) and prostate-specific antigen (PSA)-based findings for detection of csPCa in men undergoing repeat biopsies. Material and Methods MpMRI was performed prior to re-biopsy in 289 prospectively enrolled patients. All underwent repeat TRUSbx followed by targeted biopsies (MRITB) of any mpMRI-identified lesion. MpMRI suspicion grade, PSA level, and density (PSAd) were compared with biopsy results and further matched to the radical prostatectomy (RP) specimen if available. Results PCa was detected in 128/289 (44%) patients with median age, PSA, and prior negative TRUSbx of 64 (interquartile range [IQR] = 59-67), 12.0 ng/mL (IQR = 8.3-19.1), and 2 (IQR = 1-3), respectively. TRUSbx detected PCa in 108/289 (37%) patients, of which 49 (45%) had insignificant cancer. MRITB was performed in 271/289 (94%) patients and detected PCa in 96 (35%) with 78 (81%) having csPCa. MpMRI scores showed a high association between suspicion level and biopsy results on both lesion and patient level ( P < 0.001). MpMRI was better than PSA and PSAd ( P < 0.001) to identify patients with missed csPCa. In total, 64/128 (50%) patients underwent RP; 60/64 had csPCa. MpMRI was significantly better in predicting csPCa on RP compared with TRUSbx ( P = 0.019) as MRITB and TRUSbx correctly identified 47/60 (78%) and 35/60 (58%) patients, respectively. Conclusion MpMRI improves detection of missed csPCa and suspicion scores correlate well with biopsy and RP results on both patient and lesion level.

OBJECTIVE: To identify the location of missed significant prostate cancer (sPCa) lesions by transrectal ultrasound-guided biopsy (TRUSbx) and multiparametric magnetic resonance imaging-guided biopsy (mpMRIbx) in men undergoing repeat biopsies.MATERIALS AND METHODS: A total of 289 men with prior negative TRUSbx underwent multiparametric magnetic resonance imaging. The location of any suspicious lesion was registered and scored using Prostate Imaging Reporting and Data System version 1 classification according to the likelihood of being sPCa. All patients underwent repeat transrectal ultrasound-guided biopsy (reTRUSbx) and targeted mpMRIbx (image fusion) of any suspicious lesion. Biopsy results were compared and the locations of missed sPCa lesions were registered. Cancer significance was defined as (1) any core with a Gleason score of >6, (2) cancer core involvement of ≥50% and for reTRUSbx on patient level, and (3) the presence of ≥3 positive cores.RESULTS: Of the 289 patients, prostate cancer was detected in 128 (44%) with 88 (30%) having sPCa. Overall, 165 separate prostate cancer lesions were detected with 100 being sPCa. Of these, mpMRIbx and reTRUSbx detected 90% (90/100) and 68% (68/100), respectively. The majority of sPCa lesions (78%) missed by primary TRUSbx were located either anteriorly or in the apical region. Missed sPCa lesions at repeat biopsy were primarily located anteriorly (84%) for reTRUSbx (n = 27/32) and posterolateral midprostatic (60%) for mpMRIbx (n = 6/10).CONCLUSION: Both TRUSbx and mpMRIbx missed sPCa lesions in specific segments of the prostate. Missed sPCa lesions at repeat biopsy were primarily located anteriorly for TRUSbx and posterolateral midprostatic for mpMRIbx. Localization of these segments may improve biopsy techniques in men undergoing repeat biopsies.

PURPOSE: We assessed the risk of significant prostate cancer being detected after low suspicion magnetic resonance imaging or suspicious magnetic resonance imaging with benign magnetic resonance imaging guided biopsies in men with prior negative systematic biopsies.MATERIALS AND METHODS: Overall 289 prospectively enrolled men underwent magnetic resonance imaging followed by repeat systematic and targeted biopsies of any suspicious lesions at baseline. A total of 194 patients with low suspicion magnetic resonance imaging or benign target biopsies were suitable for this study. Those who were negative for prostate cancer at baseline were followed for at least 3 years. We calculated the negative predictive values of magnetic resonance imaging in ruling out any prostate cancer and significant prostate cancer, defined as any core with Gleason score greater than 6, or more than 2 positive cores/cancerous core 50% or greater.RESULTS: Prostate cancer was detected in 38 of 194 (20%) patients during the median study period of 47 months (IQR 43-52). The overall negative predictive value of magnetic resonance imaging in ruling out any and significant prostate cancer was 80% (156 of 194) and 95% (184 of 194), respectively. No patient with low suspicion magnetic resonance imaging had intermediate/high grade cancer (Gleason score greater than 6). The majority of patients with no cancer during followup (132 of 156, 85%) had a decreasing prostate specific antigen and could be monitored in primary care.CONCLUSIONS: Low suspicion magnetic resonance imaging in men with prior negative systematic biopsies has a high negative predictive value in ruling out longer term, significant cancer. Therefore, immediate repeat biopsies are of limited clinical value and could be avoided even if prostate specific antigen is persistently increased.

INTRODUCTION: The aim of the study was to compare the prostate cancer (PCa) detection rate of systematic transrectal ultrasound-guided biopsies (TRUS-bx) and multiparametric-MRI targeted biopsies (mp-MRI-bx) in a repeat biopsy setting and evaluate the clinical significance following an "MRI-targeted-only" approach.MATERIALS AND METHODS: Patients with prior negative biopsies underwent prostatic multiparametric-MRI that was scored using the Prostate Imaging Reporting and Data System (PI-RADS) classification. All underwent both repeated TRUS-bx and mp-MRI-bx using image fusion of any PI-RADS ≥3 lesion. Biopsy results from TRUS-bx, mp-MRI-bx, and the combination were compared.RESULTS: PCa was detected in 89 out of 206 (43%) patients. Of these, 64 (31%) and 74 (36%) patients were detected using mp-MRI-bx and TRUS-bx, respectively. Overall, mp-MRI-bx detected fewer patients with low-grade (Gleason score [GS] 3 + 3) cancers (14/64 vs. 41/74) and more patients with intermediate/high-grade cancers (GS ≥3 + 4) (50/64 vs. 33/74) using fewer biopsy cores compared with TRUS-bx (p < 0.001). Using an "MRI-targeted-only" approach in men with PI-RADS ≥3 lesions reduced the number of men requiring repeated biopsies by 50%, decreased low-grade cancer diagnoses by 66%, and increased intermediate/high-grade cancer diagnoses by 52%.CONCLUSIONS: MRI-targeted biopsies have a high detection rate for significant PCa in patients with prior negative transrectal ultrasound-guided biopsies and preferentially detect intermediate/high-grade compared with low-grade tumors.

Objective. This study aimed to evaluate the results of the Danish experience with the ProACT urinary continence device inserted in men with stress urinary incontinence. Material and methods. The ProACT was inserted in 114 patients. Data were registered prospectively. The main endpoints were complications, pad use per day and 24 h urinary leakage. A questionnaire evaluating symptoms and satisfaction was sent to the patients. Results. Data including preoperative and postoperative pad use and urinary leakage were available for 92 and 90 patients, respectively. A decrease in the median 24 h urinary leakage (352.5 vs 11 ml, p <0.001) and in the median number of pads used per day (4.75 vs 2.25, p = 0.001) was demonstrated. Forty-six patients had a pad use of 0-1 pads per day and/or a daily urinary leakage less than 8 g, corresponding to an overall dry rate of 50%. A decrease in urinary leakage > 50% was seen in 72 patients (80%). Complications were seen in 23 patients. All of these were treated successfully by removal of the device in the outpatient setting followed by replacement of the device. Another eight patients had a third balloon inserted to improve continence further. Fourteen patients (12%) ended up with an artificial sphincter or a urethral sling. Sixty patients (63%) experienced no discomfort and 58 (61%) reported being dry or markedly improved. Overall, 50 patients (53%) reported being very or predominantly satisfied. Conclusions. Adjustable continence balloons seem to be a good alternative in the treatment of male urinary incontinence. Complications are mild and easily treated.

Hemangioma of the prostate gland is extremely rare and only a few cases have been reported. There have been several cases of hemangioma of posterior urethra, urinary bladder and periprostatic plexus in the literature, all presenting with hematuria or hematospermia. Diagnosis of prostatic hemangioma is difficult due to its rarity and unspecific symptoms such as hematuria, hematospermia or lower urinary tract symptoms. It cannot be detected by conventional examinations such as cystoscopy or standard rectal ultrasonography.

PURPOSE: To investigate diagnostic accuracy of detection of prostate cancer by magnetic resonance: to evaluate the performance of T2WI, DCEMRI and CSI and to correlate the results with biopsy and radical prostatectomy histopathological data. MATERIALS AND METHODS: 43 patients, scheduled for radical prostatectomy, underwent prostate MR examination. Prostate cancer was identified by transrectal ultrasonographically (TRUS) guided sextant biopsy. MR examination was performed at 1.5T with an endorectal MR coil. Cancer localisation was performed on sextant-basis - for comparison between TRUS biopsy, MR techniques and histopathological findings on prostatectomy specimens. RESULTS: Prostate cancer was identified in all 43 patients by combination of the three MR techniques. The detection of prostate cancer on sextant-basis showed sensitivity and specificity: 50% and 91% for TRUS, 72% and 55% for T2WI, 49% and 69% for DCEMRI, and 46% and 78% for CSI. CONCLUSION: T2WI, DCEMRI and CSI in combination can identify prostate cancer. Further development of MR technologies for these MR methods is necessary to improve the detection of the prostate cancer

The incidence of prostate cancer is increasing sharply in Denmark and an increasing proportion of patients have clinically localised disease at diagnosis. The therapeutic strategy encompasses intended curative therapy: radical prostatectomy with complete removal of the prostate gland and seminal vesicles performed as an open procedure or laparoscopically, external beam radiation therapy, or implantation of radioactive seeds into the prostate (brachytherapy). In older patients with good prognostic factors, active surveillance should be considered. The various therapeutic modalities are reviewed.