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BACKGROUND: Digital health applications (DiGA) were included in the German healthcare system in 2020. They are available for prescription and reimbursed by public and private insurance companies. For the specialty of urology, there are currently two DiGA available: for the treatment of erectile dysfunction and benign prostatic hyperplasia/overactive bladder (BPH/OAB). The legal basis, clinical results and practical implementation are presented. METHODS: Evaluation of websites and publications to show the regulatory requirements, mode of action, results of clinical trials and prescribing practice with DiGA. RESULTS: Since 2020, 63 DiGA have been listed in the register of the Federal Office for Drugs and Medical Devices (BfArM), 35 of them definitively. Two urological DiGA aim to treat erectile dysfunction and BPH/OAB. Randomized, controlled studies have shown a significant and clinically relevant patient benefit for both DiGA. Further urological DiGA are in clinical development. CONCLUSIONS: DiGAs offer multimodal therapy combinations that have not yet been used in clinical practice and show a multidimensional benefit for the patient.
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BACKGROUND AND OBJECTIVE: While international guidelines advocate for a multifaceted approach to treating erectile dysfunction (ED) involving physical activities, psychological support, and education, structured programs are infrequent. To address this gap, an app-based therapy was developed, offering a systematic approach. This randomized, single-blind controlled trial aimed to assess the effectiveness of an app-based therapeutic in improving ED. METHODS: A total of 241 patients (49.74, standard deviation 12.73 yr) with ED (International Index of Erectile Function [IIEF]-5 <22) were randomized to the 12-wk app-based therapy (treatment group [TG], n = 122) or a waiting list for the app with continuation of their current management protocol (control group [CG], n = 119). Patients on long-term medication for ED were included, but subsequent exclusion occurred for those starting new medication. Coprimary endpoints were improvements from baseline to 12 wk in erectile function (IIEF-5), disease-related quality of life (QOL-Med-15), and patient activation (Patient Activation Measure [PAM-13]). KEY FINDINGS AND LIMITATIONS: Erectile function (IIEF-5) improved by 4.5 points in the TG versus 0.2 points in the CG (p < 0.0001, 95% confidence interval [CI] 3.4-5.0) group. Quality of life (QOL-Med) improved by 20.5 points in the TG versus -0.0 points in the CG (p < 0.0001, 95% CI 19.2-26.0) group. Patient activation (PAM-13) improved by 11.2 points in the TG versus 0.6 points in the CG (p < 0.0001, 95% CI 9.1-13.6) group. Phosphodiesterase type 5 inhibitor intake had no influence on all observed treatment effects. CONCLUSIONS AND CLINICAL IMPLICATIONS: App-based therapy of patients with ED provided a significant, clinically meaningful improvement. Quality of life and patient activation were also enhanced significantly. This program has the potential to change clinical practice in the treatment of ED. PATIENT SUMMARY: A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.
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PURPOSE: Female urologists are distinctly underrepresented in leading positions. The reasons behind this inequity remain unclear, with some suggesting factors such as family responsibilities, part-time work and insufficient mentorship. This study aimed to explore and characterize the working conditions of female urologists in Germany, with a focus on factors influencing the working time model. METHODS: A questionnaire was developed and distributed to 1343 female members of the German Society of Urology between February and March 2022. The survey consisted of 43 questions covering the categories demographics, occupation situation, satisfaction at work, family situation, career aspects and research activity. RESULTS: Of the 487 female German urologists who participated in the survey, 167 (34.3%) worked part-time. Doctors in training were significantly less likely to work part-time than colleagues who had completed their specialist training (p < 0.001). Only 10% of female doctors in training reported working part-time. Similarly, having children (p < 0.001) and engaging in scientific activities (p = 0.03) were independent factors influencing part-time work, with children increasing the likelihood of working part-time as expected, while scientifically active female urologists were more likely to work full-time. CONCLUSION: This study provides the largest survey on the situation of female urologists in German-speaking countries to date. Part-time work during specialist training is rare, while more than 50% of female urologists with children work part-time. With the projected decline in the number of practicing physicians and the increasing demand for medical attention, it is crucial to find ways to retain and support healthcare professionals, particularly female urologists.
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Urologistas , Urologia , Criança , Humanos , Feminino , Urologia/educação , Inquéritos e Questionários , AlemanhaRESUMO
INTRODUCTION: Job satisfaction is a valuable good. However, literature on job satisfaction of female and male physicians, especially in the field of urology, is scarce. Therefore, the aim of this study was to evaluate job satisfaction among female members of the German Society of Urology (DGU). MATERIALS AND METHODS: An online questionnaire was sent to 1343 female members of the DGU in Germany, Austria, and Switzerland. The responses of 521 female physicians were statistically analyzed regarding baseline characteristics and in relation to job satisfaction and satisfaction with the choice of specialty. RESULTS: The median age of the participants was 37 (IQR 33; 45) years. While 91% of the respondents were rather or very satisfied with their choice of specialty-urology-only about 54% of the female urologists were satisfied with their job situation. Of the female urologists satisfied (vs. not satisfied) with their professional situation, 95% (vs. 87%) were also satisfied with their choice of urology as their specialty. Satisfaction with the working time model (odds ratio [OR] 9.61) and feeling unequal treatment (OR: 0.18) were independent predictors of satisfaction with the professional situation. CONCLUSION: Considering the increasing proportion of women in the health sector, it is important to identify factors influencing decisions on career and choice of specialty as well as career progression. Achieving career goals, increasing satisfaction with the working time model, and reducing unequal treatment or discrimination are central arguments for sustainably increasing the job satisfaction of female urologists.
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Médicos , Urologia , Humanos , Masculino , Feminino , Urologistas , Satisfação no Emprego , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The proportion of female urologists is steadily increasing, yet they continue to be underrepresented in academic leadership positions. A postdoctoral lecture qualification (habilitation), which is mandatory for a successful scientific career, is achieved significantly less often by female urologists in Germany than by their male colleagues. OBJECTIVE: To identify factors to effectively promote female urologists into academic leadership positions, the current situation, as well as factors influencing successful habilitation of women who are members of the German Society of Urology (Deutsche Gesellschaft für Urologie [DGU]) were investigated. METHODS: An online questionnaire was distributed to 1343 female members of the DGU in Germany, Austria, and Switzerland. The responses of 521 women were statistically analyzed with respect to baseline characteristics and in relation to research funding. The primary endpoint of our study was the habilitation rate. RESULTS: The average age of the 521 participating female urologists who completed the questionnaire was 37 years (range 21-67 years). Of these, most female physicians were in postgraduate training (nâ¯= 168, 32%), worked full-time (nâ¯= 324, 62%), and had children (nâ¯= 277, 53%). Overall, 359 (69%) of the participants had a PhD and 63 (12%) were still working on their PhD. Thirty (5.8%) female urologists had a habilitation. In univariable logistic regression models, age (odds ratio [OR] 1.06), working time model (part-time OR 0.19), a research fellowship (OR 21.4), release from clinical work for research purposes (OR 13.7), and participation in a funding program (OR 6.9) or mentoring program (OR 7.0) were independent predictors of achieving habilitation. Whether a urologist had children was not an independent predictor of achieving habilitation. In multivariable logistic regression models, age (OR 1.08), and a research fellowship (OR 9.04) were independent predictors of achieving habilitation. CONCLUSIONS: Promoting habilitation among female urologists is required in order to increase the proportion of women in leading academic positions. The results of the data analysis show that the promotion of research fellowships explicitly for women could be a promising approach.
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Urologia , Adulto , Idoso , Bolsas de Estudo , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Urologistas , Urologia/educação , Adulto JovemRESUMO
Magnetic resonance imaging/Ultrasound (MRI/US) fusion targeted biopsy (TB) in combination with a systematic biopsy (SB) improves cancer detection but limited data is available how to manage patients with a Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 4 lesion and a negative biopsy. We evaluate the real-world management and the rate of clinically significant Prostate Cancer (csPCa) during follow-up. 1546 patients with a multi-parametric MRI (mpMRI) and a PI-RADS ≥ 3 who underwent SB and TB between January 2012 and May 2017 were retrospectively analyzed. 222 men with a PI-RADS ≥ 4 and a negative biopsy were included until 2019. For 177/222 (80%) complete follow-up data was obtained. 66/84 (78%) had an initial PI-RADS 4 and 18 (22%) a PI-RADS 5 lesion. 48% (84/177) received a repeat mpMRI; in the follow-up mpMRI, 39/84 (46%) lesions were downgraded to PI-RADS 2 and 11 (13%) to PI-RADS 3; three cases were upgraded and 28 lesions remained consistent. 18% (32/177) men underwent repeated TB and csPCa was detected in 44% (14/32). Our study presents real world data on the management of men with a negative TB biopsy. Men with a positive mpMRI and lesions with high suspicion (PI-RADS4/5) and a negative targeted biopsy should be critically reviewed and considered for repeat biopsy or strict surveillance. The optimal clinical risk assessment remains to be further evaluated.
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Imageamento por Ressonância Magnética , Neoplasias da Próstata , Seguimentos , Humanos , Biópsia Guiada por Imagem , Masculino , Neoplasias da Próstata/patologia , Estudos RetrospectivosRESUMO
OBJECTIVE: To compare the efficacy of multiparametric magnetic resonance imaging (mpMRI)-directed and micro-ultrasonography (micro-US)-directed biopsy for detecting clinically significant (Grade Group >1) prostate cancer (csPCa). MATERIALS AND METHODS: A total of 203 patients were prospectively enrolled at three institutions across Germany and Austria in the period from January 2019 to December 2019. During each biopsy, the urologist was blinded to the mpMRI report until after the micro-US targets had been assessed. After unblinding, targets were then sampled using software-assisted fusion, followed by systematic samples. The primary outcome measure was non-inferiority of micro-US to detect csPCa, with a detection ratio of at least 80% that of mpMRI. RESULTS: A total of 79 csPCa cases were detected overall (39%). Micro-US-targeted biopsy detected 58/79 cases (73%), while mpMRI-targeted biopsy detected 60/79 (76%) and non-targeted (completion sampling) samples detected 45/79 cases (57%). mpMRI-targeted samples alone detected 7/79 (9%) csPCa cases which were missed by micro-US-targeted and non-targeted samples. Three of these seven were anterior lesions with 2/7 in the transition zone. Micro-US-targeted samples alone detected 5/79 (6%) and completion sampling alone detected 4/79 cases (5%). Micro-US was non-inferior to mpMRI and detected 97% of the csPCa cases detected by mpMRI-targeted biopsy (95% CI 80-116%; P = 0.023). CONCLUSIONS: This is the first multicentre prospective study comparing micro-US-targeted biopsy with mpMRI-targeted biopsy. The study provides further evidence that micro-US can reliably detect cancer lesions and suggests that micro-US biopsy might be as effective as mpMRI for detection of csPCA. This result has significant implications for increasing accessibility, reducing costs and expediting diagnosis.
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Biópsia Guiada por Imagem , Neoplasias da Próstata , Humanos , Biópsia Guiada por Imagem/métodos , Imageamento por Ressonância Magnética/métodos , Masculino , Estudos Prospectivos , Neoplasias da Próstata/patologia , UltrassonografiaRESUMO
BACKGROUND: Although multiparametric magnetic resonance imaging (mpMRI) revolutionized the implementation of prostate biopsies, a considerable amount of clinically significant prostate cancer (csPCa) is missed when performing mpMRI-targeted biopsies only. Microultrasound (micro-US) is a new modality that allows real-time targeting of suspicious regions. OBJECTIVE: To evaluate micro-US of the prostate with real-time targeting of suspicious regions in patients suspected to have prostate cancer (PCa). DESIGN, SETTING, AND PARTICIPANTS: We examined 159 patients with prior mpMRI and suspicion of PCa with micro-US in the period from February to December 2018. Micro-US lesions were documented according to the prostate risk identification for micro-US (PRI-MUS) protocol, and were blinded to the mpMRI results and targeted independently of the mpMRI lesions. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The main outcomes were cancer detection rate, additional detection of csPCa, and International Society of Urological Pathology (ISUP) grade group upgrading via micro-US. RESULTS AND LIMITATIONS: PCa was found in 113/159 (71%) men, with 49% (78/159) having clinically significant cancer (csPCa; ISUP ≥ 2). Micro-US-targeted biopsies resulted in a higher ISUP grade group than the nontargeted biopsies in 26% (42/159), compared with both nontargeted and MRI-targeted biopsies in 16% (26/159). In 17% (27/159) of patients, targeted mpMRI-guided biopsy was negative with cancer identified in the micro-US-guided biopsy, of whom 20 had csPCa. The comparison with only MRI-positive patients is the main limitation of this analysis. CONCLUSIONS: Our data show an added benefit of micro-US in addition to mpMRI-targeted biopsies in a population of men at risk of PCa. A novel biopsy protocol with solely targeted biopsy with micro-US and mpMRI seems possible, replacing conventional ultrasound and omitting standard systematic biopsies. PATIENT SUMMARY: In this report, we looked at the performance of microultrasound in the setting of diagnosing prostate cancer. We found that microultrasound is a good addition to magnetic resonance imaging (MRI) of the prostate and presents an alternative for men who may not undergo MRI.
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Imageamento por Ressonância Magnética Multiparamétrica , Neoplasias da Próstata , Humanos , Biópsia Guiada por Imagem/métodos , Imageamento por Ressonância Magnética , Masculino , Próstata/diagnóstico por imagem , Próstata/patologia , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologiaRESUMO
INTRODUCTION: High-resolution micro-ultrasound has the capability of imaging prostate cancer based on detecting alterations in ductal anatomy, analogous to multiparametric magnetic resonance imaging (mpMRI). This technology has the potential advantages of relatively low cost, simplicity, and accessibility compared to mpMRI. This multicenter, prospective registry aims to compare the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of mpMRI with high-resolution micro-ultrasound imaging for the detection of clinically significant prostate cancer. METHODS: We included 1040 subjects at 11 sites in seven countries who had prior mpMRI and underwent ExactVu micro-ultrasound-guided biopsy. Biopsies were taken from both mpMRI targets (Prostate Imaging-Reporting and Data System [PI-RADS] >3 and micro-ultrasound targets (Prostate Risk Identification using Micro-ultrasound [PRIMUS] >3). Systematic biopsies (up to 14 cores) were also performed. Various strategies were used for mpMRI target sampling, including cognitive fusion with micro-ultrasound, separate software-fusion systems, and software-fusion using the micro-ultrasound FusionVu system. Clinically significant cancer was those with Gleason grade group ≥2. RESULTS: Overall, 39.5% were positive for clinically significant prostate cancer. Micro-ultrasound and mpMRI sensitivity was 94% vs. 90%, respectively (p=0.03), and NPV was 85% vs. 77%, respectively. Specificities of micro-ultrasound and MRI were both 22%, with similar PPV (44% vs. 43%). This represents the initial experience with the technology at most of the participating sites and, therefore, incorporates a learning curve. Number of cores, diagnostic strategy, blinding to MRI results, and experience varied between sites. CONCLUSIONS: In this initial multicenter registry, micro-ultrasound had comparable or higher sensitivity for clinically significant prostate cancer compared to mpMRI, with similar specificity. Micro-ultrasound is a low-cost, single-session option for prostate screening and targeted biopsy. Further larger-scale studies are required for validation of these findings.
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The aim of this paper was to compare the perioperative and postoperative results of photoselective vaporization of the prostate with the GreenLight-XPS 180 Watt System (PVP) and transurethral resection of the prostate (TURP). This retrospective study included 140 men who underwent PVP and 114 men who underwent TURP for symptomatic benign prostate enlargement (BPE) between June 2010 and February 2015. The primary outcome measures were the patient reported outcome, operative results, International Prostate Symptom Score-Quality of Life (IPSS-QoL), complication rates, catheterization time, and length of hospital stay. The median follow-up times were 27 months (range 14-44) for the PVP group and 36 months (range 25-47) for the TURP group. The patient characteristics were well balanced in both groups with a median age of 71 years (PVP group) vs. 70 years (TURP group) and a comparable prostate volume (median 50 mL in the PVP group vs. 45 mL in the TURP group). The IPSS-QoL was significantly higher in the PVP group than in the TURP group (median 22 + 4; range 16-27 + 3-5 vs. median 19 + 3; range 15-23 + 3-4; p = 0.02). Men undergoing PVP were more likely to be on anticoagulants (PVP group n = 23; 16% vs. TURP group n = 2; 2%, p < 0.001). The median operation time (OT; min) for both procedures was comparable with 68 min (PVP group; range 53-91) vs. 67 min (TURP group; range 46-85). The rate of severe intraoperative bleeding was significantly lower in the PVP group than in the TURP group (n = 7; 5% vs. n = 16; 14%; p = 0.01). The postoperative catheterization time and length of hospital stay was significantly lower in the PVP group (median 1-2 days; range 1-4) vs. the TURP group (median 2-4 days; range 2-5; both p < 0.001). Complication rates (Clavien-Dindo classification ≥III) based on the follow-up data showed no statistically significant difference between the PVP group and the TURP group (n = 6; 4% vs. n = 6; 5%; p = 0.28). The IPSS on follow-up showed an equivalent reduction in symptoms for both treatment modalities (IPSS-QoL of 5 + 1; range 2-11 + 0-2 for both). There were no differences concerning urge (PVP group n = 3; 2% vs. TURP group n = 3; 3%; p = 0.90) and men were similarly satisfied with the postoperative outcome (PVP group 92% vs. TURP group 87%; p = 0.43). The PVP group was associated with a shorter hospitalization time and showed a reduced risk of bleeding, despite patients remaining on anticoagulants, without increasing the overall operative time. There was no difference in the patient reported outcome for both procedures.
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PURPOSE: The second version of the PI-RADS™ (Prostate Imaging Reporting and Data System) was introduced in 2015 to standardize the interpretation and reporting of prostate multiparametric magnetic resonance imaging. Recently low cancer detection rates were reported for PI-RADS version 2 category 4 lesions. Therefore the aim of the study was to evaluate the cancer detection rate of PI-RADS version 2 in a large prospective cohort. MATERIALS AND METHODS: The study included 704 consecutive men with primary or prior negative biopsies who underwent magnetic resonance imaging/ultrasound fusion guided targeted biopsy and 10-core systematic prostate biopsy between September 2015 and May 2017. All lesions were rated according to PI-RADS version 2 and lesions with PI-RADS version 2 category 3 or greater were biopsied. An ISUP (International Society of Urological Pathology) score of 2 or greater (ie Gleason 3 + 4 or greater) was defined as clinically significant prostate cancer. RESULTS: The overall cancer detection rate of PI-RADS version 2 categories 3, 4 and 5 was 39%, 72% and 91% for all prostate cancer, and 23%, 49% and 77% for all clinically significant prostate cancer, respectively. If only targeted biopsy had been performed, 59 clinically significant tumors (16%) would have been missed. The PI-RADS version 2 score was significantly associated with the presence of prostate cancer (p <0.001), the presence of clinically significant prostate cancer (p <0.001) and the ISUP grade (p <0.001). CONCLUSIONS: PI-RADS version 2 is significantly associated with the presence of clinically significant prostate cancer. The cancer detection rate of PI-RADS version 2 category 4 lesions was considerably higher than previously reported. When performing targeted biopsy, the combination with systematic biopsy still provides the highest detection of clinically significant prostate cancer.
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Biópsia Guiada por Imagem/métodos , Imagem por Ressonância Magnética Intervencionista/métodos , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Projetos de Pesquisa , Ultrassonografia Doppler/métodos , Idoso , Estudos de Coortes , Sistemas de Dados , Humanos , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Invasividade Neoplásica/patologia , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To examine the performance of a primary magnetic resonance imaging (MRI)/ultrasonography (US) fusion-guided targeted biopsy (TB), and in combination with an added systematic biopsy (SB). PATIENTS AND METHODS: Analysis of 318 consecutive biopsy-naïve men with suspicious multiparametric MRI (mpMRI; Prostate Imaging Reporting and Data System [PI-RADS] score ≥3) undergoing transrectal TB and 10-core SB between January 2012 and December 2016. The indication for performing mpMRI was based on clinical parameters and decided by the treating urologist before admission. TB was performed with a sensor-based MRI/US fusion-guided platform. Clinically significant prostate cancer was defined as Gleason score ≥4 + 3 = 7 (International Society of Urological Pathology Grade [ISUP] grade 3) or maximum cancer core length of ≥6 mm. RESULTS: A median (interquartile range) of 14 (13-14) biopsies per case were taken. The overall cancer detection rate (CDR) was 77% (245/318). The TB alone detected 67% of prostate cancers and the SB alone detected 70%. The PI-RADS dependent CDR for the combination of TB/SB were 38% (21/55), 78% (120/154) and 95% (104/109) for PI-RADS scores of 3/4/5, respectively. Clinically significant prostate cancer was diagnosed by the combination of TB and SB in 195 men (61%) and by TB alone in 163 cases (51%). The number of missed or underestimated prostate cancers with a Gleason score ≥8 for TB alone was 31 (10%, P < 0.001) and 21 (7%, P < 0.001) for SB alone in comparison with the results of the combination of TB and SB. The rate of insignificant prostate cancer was comparable for the combination of TB and SB and TB alone (50/318, 16% vs 50/318, 16%). CONCLUSIONS: Pre-biopsy mpMRI is of incremental value in increasing the detection of clinically significant prostate cancer in biopsy-naïve patients with suspicion of prostate cancer. Combining TB with SB further improved the diagnostic accuracy without increasing the rate of insignificant prostate cancer.
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Próstata/patologia , Neoplasias da Próstata/patologia , Idoso , Detecção Precoce de Câncer , Humanos , Biópsia Guiada por Imagem/métodos , Biópsia Guiada por Imagem/normas , Imagem por Ressonância Magnética Intervencionista/normas , Masculino , Pessoa de Meia-Idade , Gradação de Tumores , Estudos Prospectivos , Estudos Retrospectivos , Sensibilidade e Especificidade , Ultrassonografia de Intervenção/normasRESUMO
Adrenocortical carcinoma (ACC) is a rare malignancy that harbors a dismal prognosis in advanced stages. Mitotane is approved as an orphan drug for treatment of ACC and counteracts tumor growth and steroid hormone production. Despite serious adverse effects, mitotane has been clinically used for decades. Elucidation of its unknown molecular mechanism of action seems essential to develop better ACC therapies. Here, we set out to identify the molecular target of mitotane and altered downstream mechanisms by combining expression genomics and mass spectrometry technology in the NCI-H295 ACC model cell line. Pathway analyses of expression genomics data demonstrated activation of endoplasmic reticulum (ER) stress and profound alteration of lipid-related genes caused by mitotane treatment. ER stress marker CHOP was strongly induced and the two upstream ER stress signalling events XBP1-mRNA splicing and eukaryotic initiation factor 2 A (eIF2α) phosphorylation were activated by mitotane in NCI-H295 cells but to a much lesser extent in four nonsteroidogenic cell lines. Lipid mass spectrometry revealed mitotane-induced increase of free cholesterol, oxysterols, and fatty acids specifically in NCI-H295 cells as cause of ER stress. We demonstrate that mitotane is an inhibitor of sterol-O-acyl-transferase 1 (SOAT1) leading to accumulation of these toxic lipids. In ACC tissue samples we show variable SOAT1 expression correlating with the response to mitotane treatment. In conclusion, mitotane confers adrenal-specific cytotoxicity and down-regulates steroidogenesis by inhibition of SOAT1 leading to lipid-induced ER stress. Targeting of cancer-specific lipid metabolism opens new avenues for treatment of ACC and potentially other types of cancer.