RESUMO
BACKGROUND: Nivolumab plus cabozantinib (NIVO + CABO) was approved for first-line treatment of advanced renal cell carcinoma (aRCC) based on superiority versus sunitinib (SUN) in the phase III CheckMate 9ER trial (18.1 months median survival follow-up per database lock date); efficacy benefit was maintained with an extended 32.9 months of median survival follow-up. We report updated efficacy and safety after 44.0 months of median survival follow-up in intent-to-treat (ITT) patients and additional subgroup analyses, including outcomes by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk score. PATIENTS AND METHODS: Patients with treatment-naïve aRCC received NIVO 240 mg every 2 weeks plus CABO 40 mg once daily or SUN 50 mg for 4 weeks (6-week cycles), until disease progression/unacceptable toxicity (maximum NIVO treatment, 2 years). Primary endpoint was progression-free survival (PFS) per blinded independent central review (BICR). Secondary endpoints were overall survival (OS), objective response rate (ORR) per BICR, and safety and tolerability. RESULTS: Overall, 323 patients were randomised to NIVO + CABO and 328 to SUN. Median PFS was improved with NIVO + CABO versus SUN [16.6 versus 8.4 months; hazard ratio (HR) 0.59; 95% confidence interval (CI) 0.49-0.71]; median OS favoured NIVO + CABO versus SUN (49.5 versus 35.5 months; HR 0.70; 95% CI 0.56-0.87). ORR (95% CI) was higher with NIVO + CABO versus SUN [56% (50% to 62%) versus 28% (23% to 33%)]; 13% versus 5% of patients achieved complete response, and median duration of response was 22.1 months versus 16.1 months, respectively. PFS and OS favoured NIVO + CABO over SUN across intermediate, poor and intermediate/poor IMDC risk subgroups; higher ORR and complete response rates were seen with NIVO + CABO versus SUN regardless of IMDC risk subgroup. Any-grade (grade ≥3) treatment-related adverse events occurred in 97% (67%) versus 93% (55%) of patients treated with NIVO + CABO versus SUN. CONCLUSIONS: After extended follow-up, NIVO + CABO maintained survival and response benefits; safety remained consistent with previous follow-ups. These results continue to support NIVO + CABO as a first-line treatment for aRCC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03141177.
Assuntos
Anilidas , Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma de Células Renais , Neoplasias Renais , Nivolumabe , Piridinas , Sunitinibe , Humanos , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/mortalidade , Sunitinibe/uso terapêutico , Sunitinibe/farmacologia , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/patologia , Neoplasias Renais/mortalidade , Masculino , Anilidas/uso terapêutico , Anilidas/farmacologia , Feminino , Pessoa de Meia-Idade , Nivolumabe/uso terapêutico , Nivolumabe/farmacologia , Piridinas/uso terapêutico , Piridinas/farmacologia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Adulto , Seguimentos , Intervalo Livre de ProgressãoRESUMO
We present the case of a 57-year-old man who developed an intraperitoneal bladder fistula with BCG-induced (bacillus Calmette-Guérin) abdominal granulomatosis after transurethral resection of a papillary non-muscle invasive bladder cancer and subsequent BCG-instillation therapy. The bladder fistula was eliminated surgically. The detection of Mycobacterium tuberculosis in the operative sample drawings as well as the histological detection of BCG-granuloma led to specific treatment and a report to the responsible health department.
Assuntos
Doenças da Bexiga Urinária , Neoplasias da Bexiga Urinária , Administração Intravesical , Vacina BCG/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Doenças da Bexiga Urinária/induzido quimicamente , Doenças da Bexiga Urinária/diagnóstico , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/cirurgiaRESUMO
BACKGROUND: CD276 is an immune checkpoint molecule. Elevated CD276 expression by urothelial carcinoma is associated with poor prognosis, but little is known about its expression across different tumor stages. We therefore investigated CD276 expression in bladder cancer (BC) cells and in tissue samples of BC stages from pT2 to pT4. METHODS: CD276 expression was explored in 4 urothelial cancer cell lines and 4 primary normal urothelial cell populations by quantitative RT-PCR, Western blot and flow cytometry. CD276 was investigated in bladder tumors from 98 patients by immunohistochemistry using a score (0-300) incorporating both, staining intensity and area of CD276 staining. Normal appearing urothelium in the bladder of the same patients served as controls. RESULTS: The urothelial carcinoma cell lines expressed significantly higher levels of CD276 on transcript (p < 0.006), total protein levels (p < 0.005), and on the cell surface (p < 0.02) when compared to normal urothelial cells. In pT2-T4 tumor tissue samples, CD276 was overexpressed (median score 185) when compared to corresponding healthy tissues from the same patients (median score 50; p < 0.001). No significant differences in CD276 expression were recorded in late, locally advanced ≥ pT3a tumors (median score 185) versus organ-confined < pT3a tumors (median score 190), but it was significantly lower in the normal urothelial tissue associated with ≥ pT3a tumors (median score 40) versus < pT3a tumors (median score 80; p < 0.05). CONCLUSION: CD276 expression is significantly elevated in urothelial carcinoma cells in all stages but varies between individuals considerably. Reduced CD276 expression in normal urothelial cells may imply that these cells would be protected from CD276-mediated immuno therapies.
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Antígenos B7/genética , Carcinoma de Células de Transição/genética , Regulação Neoplásica da Expressão Gênica , Neoplasias da Bexiga Urinária/genética , Adulto , Idoso , Idoso de 80 Anos ou mais , Antígenos B7/análise , Carcinoma de Células de Transição/química , Carcinoma de Células de Transição/patologia , Linhagem Celular Tumoral , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias da Bexiga Urinária/química , Neoplasias da Bexiga Urinária/patologiaRESUMO
Background: We evaluated efficacy and toxicity of 68Ga-PSMA-Positron Emission Tomography/Computed Tomography (PET/CT)-directed stereotactic body radiotherapy and image-guided radiotherapy (SBRT/IGRT) for oligometastases of prostate cancer recurrences after previous surgery.Methods: Nineteen patients were analyzed within a prospective PET-registry study (064/2013BO1) and retrospectively analyzed (807/2017BO2) fulfilling the following inclusion criteria: biochemical recurrence after radical prostatectomy, ≤five 68Ga-PSMA-PET/CT positive lesions. Biochemical control was evaluated with EORTC (European Organization for Research and Treatment of Cancer)- and Phenix-definitions. Toxicity was scored according to CTCAE-criteria v. 4.03.Results: A total of 38 oligometastases (19 patients, 2 with re-treatment) were treated with SBRT/IGRT from October 2014 to July 2017. 68Ga-PSMA-PET/CT-positive lesions were detected on average 39 months (5-139) after prostatectomy (pT2b-3b pN0-1 cM0). Mean PSA (Prostate-specific antigen)-level at time of imaging reached 2.2 ng/mL (range 0.2-10.1). PET/CT-positive lesions were treated with different fractionation schedules reaching biological equivalent doses (BED) of 116.7-230.0 Gy. Concomitant androgen deprivation therapy (ADT) was given in seven patients. After a median follow-up of 17 months (4-42) all patients were alive. Estimated 1-year PSA- control (n = 19) reached 80.8% (Phenix) and 67.5% (EORTC). A PSA-decline (≥50%) was detected in 16/19 patients after radiotherapy. Higher graded G3+-acute toxicity did not occur. Temporary late G3-proctitis was detected in one patient.Conclusions: Reaching of nadir ≤0.1 or 0.2 ng/mL was associated by improved DMFS (distant metastases free survival) and could serve as a surrogate endpoint for RT of oligometastases after initial prostatectomy. Short term effects of 68Ga-PSMA-PET/CT-based ablative radiotherapy for oligometastases demonstrated an acceptable toxicity profile and favorable biochemical response.
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Neoplasias da Próstata/patologia , Neoplasias da Próstata/radioterapia , Idoso , Fracionamento da Dose de Radiação , Isótopos de Gálio , Radioisótopos de Gálio , Humanos , Masculino , Glicoproteínas de Membrana/uso terapêutico , Pessoa de Meia-Idade , Metástase Neoplásica , Compostos Organometálicos/uso terapêutico , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Intervalo Livre de Progressão , Estudos Prospectivos , Antígeno Prostático Específico/sangue , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/mortalidade , Radiocirurgia , Radioterapia Guiada por Imagem , Estudos RetrospectivosRESUMO
BACKGROUND: Immune checkpoint inhibitors (ICI) have led to great advances in the therapy of metastatic renal cell and urothelial carcinoma. Currently ICI are approved for the first-line therapy of cisplatin-unfit patients (Atezolizumab, Pembrolizumab) and second-line therapy in patients with metastasized urothelial cancer (Atezolizumab, Nivolumab, Pembrolizumab). For the therapy of metastasized RCC, Nivolumab is approved as a second-line therapy and in combination with the CTLA4 antibody Ipilimumab as a first-line therapy. OBJECTIVES: What does the optimized radiological follow-up and therapy response assessment for ICI, which differ in their pathways from common chemotherapeutics and anti-angiogenetic drugs, look like? What strategies are needed to meet the upcoming challenges concerning interpretation of the acquired images? METHODS: A systematic literature search was carried out for urothelial and renal cell carcinoma. RESULTS: Immune-related response criteria have been introduced to better characterize the imaging changes occurring under ICI, as monitoring response to immunotherapy still relies on RECIST. CONCLUSIONS: To properly identify and predict response after treatment with ICI, additional studies with long-term follow-ups are needed. Because of the growing use of ICI, radiologists and urologist should be familiar with common imaging findings (such as pseudo progress) under immunotherapy to correctly interpret these findings in daily routine.
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Carcinoma de Células de Transição , Fatores Imunológicos , Neoplasias Renais , Carcinoma de Células de Transição/diagnóstico por imagem , Carcinoma de Células de Transição/tratamento farmacológico , Humanos , Fatores Imunológicos/farmacologia , Imunoterapia , Ipilimumab/farmacologia , Neoplasias Renais/diagnóstico por imagem , Neoplasias Renais/tratamento farmacológicoRESUMO
Defects in ureteral continuity and function can originate from various etiologies such as stricture, radiotherapy, tuberculosis, tumor, trauma or perforation due to iatrogenic injury. The surgical options for the management of ureteral defects are complex and depend on the location of the defect. The aim of the surgical management of ureteral stricture is the reconstruction of an anti-refluxive and nonobstructive flow of urine to preserve kidney function. There are numerous possibilities for the reconstruction of ureteral defects ranging from ureteroneocystostomy with or without psoas-hitch- or Boari-flap to ileal ureteral replacement. Nearly all these techniques can either be done in open surgery or in a laparoscopically or robotic-assisted manner. The technique of robotic-assisted reconstruction of ureteral defects is challenging but offers a great opportunity. The aim of this article is to provide an overview of current surgical procedures in ureteric reconstruction.
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Cistostomia/métodos , Íleo/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Reimplante/métodos , Retalhos Cirúrgicos , Ureter/cirurgia , Obstrução Ureteral/cirurgia , Procedimentos Cirúrgicos Urológicos Masculinos/métodos , Feminino , Humanos , Laparoscopia , Estudos Retrospectivos , Resultado do Tratamento , Ureter/anormalidades , Ureter/lesões , Obstrução Ureteral/etiologiaRESUMO
Prostate cancer remains among the most commonly diagnosed malignancies worldwide in men. In patients with low-risk prostate cancer, the risk of metastasis and mortality is very low; therefore, a tumor surveillance strategy can be used. In patients undergoing active surveillance, curative active therapy is postponed without compromising opportunities for cure until there is evidence of progression or the patient desires active therapy. The aim of active surveillance in prostate cancer patients is to minimize treatment-related toxicity without impairing patient survival. To maintain patients under active surveillance, the following criteria should be met: prostate-specific antigen (PSA) ≤10â¯ng/ml, Gleason score ≤6, cT1 or cT2a, ≤2 biopsy cores with <50% cancer involvement of every positive core. Follow-up in active surveillance patients is based on repeat biopsy, serial PSA measurements, and digital rectal examination.
Assuntos
Exame Retal Digital/métodos , Gradação de Tumores/métodos , Antígeno Prostático Específico/sangue , Próstata/patologia , Neoplasias da Próstata/terapia , Biópsia , Humanos , Masculino , Estadiamento de Neoplasias/métodos , Prostatectomia , Neoplasias da Próstata/patologia , Fatores de RiscoRESUMO
Immune checkpoint inhibitors (ICI) have significantly improved the systemic therapy of metastatic disease in genitourinary malignancies. With the European Medicines Agency (EMA) approval of the antibodies nivolumab and pembrolizumab directed against programmed cell death 1 (PD-1) as well as the PD-L1 antibody atezolizumab, three agents are available for the treatment of metastatic urothelial carcinoma and renal cell carcinoma. This article describes the underlying mode of action of PD-1/PD-L1 blockade and other ICIs to activate the immune system for effective tumor rejection. Future therapeutic strategies are focusing on the combination of ICI with targeted therapies to enhance the immune defense, especially in the local tumor microenvironment. A further clinical need exists for the establishment of biomarkers to predict a therapy response under ICI, in particular for the role of the PD-L1 status. Biomarkers for predicting primary or acquired therapy resistance are also of clinical importance to enable good patient selection for ICI therapy.
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Carcinoma de Células Renais , Carcinoma de Células de Transição , Imunoterapia , Neoplasias Renais , Carcinoma de Células Renais/terapia , Humanos , Imunoterapia/tendências , Neoplasias Renais/terapia , Receptor de Morte Celular Programada 1 , Microambiente TumoralRESUMO
PURPOSE: The performance of urinary markers for detecting bladder cancer (BC) is influenced by various factors. The aim of the present study was to evaluate the influence of smoking habits on the performance of four commonly used urine markers. METHODS: Urine samples of 723 patients with suspected BC were analysed using urine cytology, fluorescence in situ hybridization (FISH), immunocytology (uCyt+ test), and quantitative nuclear matrix protein 22 (NMP22) immunoassay. The smoking habits of all patients were recorded and a cystoscopy performed within 2 weeks after urinary marker testing. Rates of false negative and false positive results were compared between non-smokers, former smokers, and current smokers by contingency analyses. RESULTS: We included 723 patients in this study, 431 (59.6%) of which were non-smokers, 215 former smokers (29.7%), and 77 (10.7%) current smokers. 148 patients (20.5%) had a tumour at the time of urinary marker testing. Respective rates of false positive test results among non-smokers, former smokers, and current smokers were: 16.3, 19.1, and 11.5% (p = 0.81) for urine cytology; 36.8, 42.0, and 32.7% for the uCyt+ test (p = 0.88); 18.0, 19.1, and 13.5% for FISH (p = 0.66); and 69.5, 71.6, and 71.2% for NMP22 (p = 0.67). Respective rates of false negatives among non-smokers, former smokers, and current smokers were: 31.4, 15.1, and 28.0% for cytology (p = 0.34); 21.4, 22.6, and 16.0% for uCyt+ test (p = 0.67); 24.3, 13.2, and 28.0% for FISH (p = 0.88); and 10.0, 18.9, and 8.0% for NMP22 (p = 0.80). CONCLUSIONS: Our results strongly suggest that smoking habits do not affect performance characteristics of urinary markers in the diagnostics of BC.
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Biomarcadores Tumorais/urina , Fumar/urina , Neoplasias da Bexiga Urinária/urina , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Feminino , Humanos , Imunoensaio , Imuno-Histoquímica , Hibridização in Situ Fluorescente , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Proteínas Nucleares/urina , Estudos Retrospectivos , Fumar/patologia , Neoplasias da Bexiga Urinária/patologia , Adulto JovemRESUMO
After surgical resection of renal cell carcinoma by laparoscopic or open partial or complete nephrectomy, medical aftercare based on the current guidelines should be provided. This seems desirable, especially because one third of patients after initial curative tumor resection develop recurrence over time. In this article, the current recommendations for follow-up will be systematically presented based on the accepted German S3 guideline and the European Association of Urology (EAU) guideline. Another point of this article will be the presentation of the currently applied risk scores to predict prognosis with a focus on molecular markers. The goal is to improve the prediction of survival and to facilitate risk-adjusted aftercare.
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Carcinoma de Células Renais/cirurgia , Neoplasias Renais/cirurgia , Nefrectomia , Guias de Prática Clínica como Assunto , Seguimentos , Humanos , Laparoscopia , Recidiva Local de NeoplasiaRESUMO
INTRODUCTION: Paraneoplastic syndromes (PNS) in renal cell carcinoma (RCC) are important to be recognized by the treating physician, because they may lead to diagnosis of underlying malignant disease. On the other hand, PNS may dominate the clinical picture and can hide the true disorder like a chameleon. When realized, a PNS can be used as a 'neoplastic tumour marker', especially in case of recurrence. Their occurrence can even be linked to prognosis of disease. METHODS: A PubMed search combining the MeSH terms renal cell carcinoma and paraneoplastic syndrome was executed in April 2015. All hits concerning these MeSH terms have been taken into account when writing this review. RESULTS: There is a big gap between reporting and incidence of paraneoplastic syndromes in renal cell carcinoma. Most of the articles in Medline are case reports and reviews of research done in the 1950s-1990s. One problem is that a clear definition of a paraneoplastic syndrome is still lacking. The most important PNS in RCC are hypercalcemia. It is important that PNS are not only arising in advanced stages of renal cell carcinoma; in contrast, a PNS can often be the first symptom of RCC. CONCLUSION: Paraneoplastic syndromes are often unrecognized but are important biomarkers in RCC. Further research into the underlying pathomechanisms of PNS may improve our understanding of the RCC tumour biology and is urgently needed.
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Carcinoma de Células Renais/diagnóstico , Neoplasias Renais/diagnóstico , Síndromes Paraneoplásicas/diagnóstico , Humanos , Hipercalcemia/diagnóstico , Hipercalcemia/etiologia , Metáfora , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/etiologiaRESUMO
Only for renal cell carcinoma (RCC) in a local stage curative treatment option by surgical resection exists. For metastatic disease the 5year survival rate decreases radically. A factor that contributes to this is the low sensibility to radiation and chemotherapeutics. Since the approval of the tyrosine kinase inhibitors in 2006 effective drugs for the treatment of mRCC is available. The specific inhibition of the vascular-endothelial-growth (VEGF)-receptor and the "mammalian Target of Rapamycin" (mTOR) leads to a prolongation of the progression-free survival as well as the overall survival rate. For a long time, the current target therapy with TKI appeared to be exhausted, but since recently research has gone a step further. Thus, Cabozantinib and Lenvatinib in the combination with Everolimus have been approved for second-line therapy in mRCC. For the first time a clinical study demonstrated positive results for an adjuvant treatment with sunitinib in patients with a high-risk RCC. Furthermore, in april 2016 the immune checkpoint inhibitor Nivolumab was approved for second-line therapy in mRCC in Germany. The following report examines briefly the current therapeutic recommendations, new findings and drug approvals and ongoing clinical trials.
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Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Everolimo/uso terapêutico , Neoplasias Renais/tratamento farmacológico , TYK2 Quinase/uso terapêutico , Animais , Alemanha , HumanosAssuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos/uso terapêutico , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/secundário , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/secundário , Carcinoma de Células Renais/patologia , Humanos , Neoplasias Renais/patologia , Metástase Linfática , Estadiamento de Neoplasias , Segunda Neoplasia Primária , Resultado do TratamentoAssuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos/efeitos adversos , Axitinibe/efeitos adversos , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/patologia , Neoplasias Renais/tratamento farmacológico , Sunitinibe/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Antineoplásicos/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica , Axitinibe/administração & dosagem , Humanos , Neoplasias Renais/patologia , Sunitinibe/administração & dosagem , Resultado do TratamentoRESUMO
PURPOSE: To clarify the value of targeted versus off-target biopsies in men with a suspicion of prostate cancer (PC) and a visible lesion in multi-parametric magnetic resonance imaging (mpMRI) using transperineal robot-assisted biopsy. METHODS: Fifty-five consecutive men with one non-palpable suspicious lesion in mpMRI after negative 12-core transrectal ultrasound-guided biopsy were enrolled in 2014-2015. Lesions were scored using the Prostate Imaging Reporting and Data System. A robot-assisted system was utilized to collect four robot-assisted targeted transperineal biopsy cores (RA-TB) within the lesion using mpMRI-TRUS elastic fusion. Untargeted transperineal 14-core biopsy was performed only outside the lesion (RA-UB). Histological grade was compared in biopsies and available prostatectomy specimens. RESULTS: Overall, 34 of 55 patients (62%) were diagnosed with PC based on biopsy. 85% of cancers were clinically significant PC (csPC) defined as GS ≥ 7. 85% of biopsy-proven cancers were detected with RA-TB alone. RA-UB identified only one additional patient with csPC and lead to upgrading in five biopsy cases (14.7%). Pathological evaluation of 14 prostatectomy specimens showed upgrading in 2 patients (14.3%), while all other patients were correctly classified by RA-TB without need of additional RA-UB. Mean procedure duration was 43 (±6) min, and only minor complications according to Clavien-Dindo were recorded during 30-day follow-up. CONCLUSIONS: This is the first report of transperineal robot-assisted elastic mpMRI-TRUS fusion biopsy. RA-TB of positive MR lesions enabled reliable detection of csPC, while RA-UB in MRI-negative regions is of minor importance.
Assuntos
Imageamento por Ressonância Magnética , Próstata , Neoplasias da Próstata , Robótica/métodos , Ultrassonografia de Intervenção , Idoso , Humanos , Biópsia Guiada por Imagem/instrumentação , Biópsia Guiada por Imagem/métodos , Imageamento Tridimensional/métodos , Imageamento por Ressonância Magnética/instrumentação , Imageamento por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Próstata/diagnóstico por imagem , Próstata/patologia , Prostatectomia/métodos , Neoplasias da Próstata/diagnóstico , Neoplasias da Próstata/patologia , Reprodutibilidade dos Testes , Ultrassonografia de Intervenção/instrumentação , Ultrassonografia de Intervenção/métodosRESUMO
BACKGROUND: Injuries of the urinary bladder can be associated with blunt and penetrating abdominal or pelvic trauma. In addition, they can be an iatrogenic complication in open, laparoscopic, and endoscopic urogenital or abdominal surgery. OBJECTIVES: The present article reviews relevant causes of bladder injuries and the subsequent diagnostic and treatment modalities.
Assuntos
Técnicas de Diagnóstico Urológico , Tratamento de Emergência/métodos , Bexiga Urinária/diagnóstico por imagem , Bexiga Urinária/lesões , Ferimentos e Lesões/diagnóstico , Ferimentos e Lesões/terapia , Estado Terminal , Diagnóstico Diferencial , Emergências , Serviços Médicos de Emergência/métodos , Medicina Baseada em Evidências , Alemanha , Humanos , Resultado do TratamentoRESUMO
PURPOSE: Multiparametric magnetic resonance imaging (mpMRI) improves diagnostic accuracy in re-biopsies of men with prostate cancer (PC) suspicion, but predictive value is limited despite the use of the new Prostate Imaging Reporting and Data System (PI-RADS). Prognostic value of the PC-specific biomarker prostate cancer gene 3 (PCA3) added to the PI-RADS score was evaluated. METHODS: The study was a retrospective analysis of the institutional database for men with MR-guided biopsy (MR-GB) for suspicious lesion in mpMRI and who had an additional pre-MR-GB PCA3 testing for ongoing PC suspicion. All men had ≥ 1 negative ultrasound GB. Lesions were retrospectively scored by PI-RADS in three MRI sequences (T2w, DCE, and DWI). PCA3 was analyzed with cutoffs of 25 and 35. The prognostic value of mpMRI and PCA3 and the additional value of both were explored. RESULTS: Tumor detection rate (49 men, mean PSA 10 ng/ml, lesion size 40 mm(2)) was 45 % (22/49 patients). In the subgroup of PI-RADS IV°, 17/17 patients had PC; in PI-RADS III° (intermediate) 5/15 had PC, and all 5 had a PCA3 > 35. PCA3 > 35 had no additional prognostic value in the whole cohort. Out of the 10/15 PC negative patients (PI-RADS III°), PCA3 was < 35 in 6. The inclusion of PCA3 value in PI-RADS III° patients improved predictive accuracy to 91.8 %. CONCLUSION: MpMRI and subsequent grading to PI-RADS significantly improves PC detection in the re-biopsy setting. The diagnostic uncertainty in the PI-RADS intermediate group can be ameliorated by the addition of PCA3 cutoff of 35 to avoid potential unnecessary biopsies.