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1. PI-QUAL version 2: an update of a standardised scoring system for the assessment of image quality of prostate MRI

Author

de Rooij, Maarten, Allen, Clare, Twilt, Jasper J., Thijssen, Linda C. P., Asbach, Patrick, Barrett, Tristan, Brembilla, Giorgio, Emberton, Mark, Gupta, Rajan T., Haider, Masoom A., Kasivisvanathan, Veeru, Løgager, Vibeke, Moore, Caroline M., Padhani, Anwar R., Panebianco, Valeria, Puech, Philippe, Purysko, Andrei S., Renard-Penna, Raphaële, Richenberg, Jonathan, Salomon, Georg, Sanguedolce, Francesco, Schoots, Ivo G., Thöny, Harriet C., Turkbey, Baris, Villeirs, Geert, Walz, Jochen, Barentsz, Jelle, and Giganti, Francesco

Published
2024
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2. Evaluation of tumor microenvironment and biomarkers of immune checkpoint inhibitor response in metastatic renal cell carcinoma

Author

Brown, Landon C, Zhu, Jason, Desai, Kunal, Kinsey, Emily, Kao, Chester, Lee, Yong Hee, Pabla, Sarabjot, Labriola, Matthew K, Tran, Jennifer, Dragnev, Konstantin H, Tafe, Laura J, Dayyani, Farshid, Gupta, Rajan T, McCall, Shannon, George, Daniel J, Glenn, Sean T, Nesline, Mary K, George, Saby, Zibelman, Matthew, Morrison, Carl, Ornstein, Moshe C, and Zhang, Tian

Subjects
Cancer, Clinical Research, Immunization, Kidney Disease, Vaccine Related, Prevention, Genetics, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, 4.1 Discovery and preclinical testing of markers and technologies, Good Health and Well Being, Humans, B7-H1 Antigen, Carcinoma, Renal Cell, CTLA-4 Antigen, Forkhead Transcription Factors, Immune Checkpoint Inhibitors, Ipilimumab, Kidney Neoplasms, Nivolumab, Retrospective Studies, Tumor Microenvironment, Immunotherapy, Tumor Biomarkers, Gene Expression Profiling
Abstract

BackgroundImmunotherapy combinations including ipilimumab and nivolumab are now the standard of care for untreated metastatic renal cell carcinoma (mRCC). Biomarkers of response are lacking to predict patients who will have a favorable or unfavorable response to immunotherapy. This study aimed to use the OmniSeq transcriptome-based platform to develop biomarkers of response to immunotherapy.MethodsTwo cohorts of patients were retrospectively collected. These included an investigational cohort of patients with mRCC treated with immune checkpoint inhibitor therapy from five institutions, and a subsequent validation cohort of patients with mRCC treated with combination ipilimumab and nivolumab from two institutions (Duke Cancer Institute and Cleveland Clinic Taussig Cancer Center). Tissue-based RNA sequencing was performed using the OmniSeq Immune Report Card on banked specimens to identify gene signatures and immune checkpoints associated with differential clinical outcomes. A 5-gene expression panel was developed based on the investigational cohort and was subsequently evaluated in the validation cohort. Clinical outcomes including progression-free survival (PFS) and overall survival (OS) were extracted by retrospective chart review. Objective response rate (ORR) was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1.ResultsThe initial investigation cohort identified 86 patients with mRCC who received nivolumab (80%, 69/86), ipilimumab/nivolumab (14%, 12/86), or pembrolizumab (6%, 5/86). A gene expression score was created using the top five genes found in responders versus non-responders (FOXP3, CCR4, KLRK1, ITK, TIGIT). The ORR in patients with high gene expression (GEhigh) on the 5-gene panel was 29% (14/48), compared with low gene expression (GElow) 3% (1/38, χ2 p=0.001). The validation cohort was comprised of 62 patients who received ipilimumab/nivolumab. There was no difference between GEhigh and GElow in terms of ORR (44% vs 38.5%), PFS (HR 1.5, 95% CI 0.58 to 3.89), or OS (HR 0.96, 95% CI 0.51 to 1.83). Similarly, no differences in ORR, PFS or OS were observed when patients were stratified by tumor mutational burden (high=top 20%), PD-L1 (programmed death-ligand 1) expression by immunohistochemistry or RNA expression, or CTLA-4 (cytotoxic T-lymphocytes-associated protein 4) RNA expression. The International Metastatic RCC Database Consortium (IMDC) risk score was prognostic for OS but not PFS.ConclusionA 5-gene panel that was associated with improved ORR in a predominantly nivolumab monotherapy population of patients with mRCC was not predictive for radiographic response, PFS, or OS among patients with mRCC treated with ipilimumab and nivolumab.

Published
2022

3. Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: Recommendations of an international Delphi consensus

Author

Tan, Wei Phin, Rastinehad, Ardeshir R, Klotz, Laurence, Carroll, Peter R, Emberton, Mark, Feller, John F, George, Arvin K, Gill, Inderbir S, Gupta, Rajan T, Katz, Aaron E, Lebastchi, Amir H, Marks, Leonard S, Marra, Giancarlo, Pinto, Peter A, Song, Daniel Y, Sidana, Abhinav, Ward, John F, Sanchez-Salas, Rafael, de la Rosette, Jean, Polascik, Thomas J, Authors, Focal Therapy Group, Katz, Aaron, Aminsharifi, Alireza, Lebastchi, Amir, Abreu, Andre, Villers, Arnauld, Schulman, Ariel, Rastinehad, Ardeshir, George, Arvin, Oto, Aytekin, Turkbey, Baris, Malavaud, Bernard, Muller, Berrend, Moore, Caroline, Eberli, Daniel, Margolis, Daniel, Song, Daniel, Lomas, Derek, Orabi, Hazem, Lepor, Herbert, Tan, Hui Meng, Jambor, Ivan, Grummet, Jeremy, Feller, John, Ward, John, Colemen, Jonathan, Gregg, Justin, Tay, Kae Jack, Marks, Leonard, Deane, Leslie, Laguna, M Pilar, Kimura, Masaki, Tsivian, Matvey, Gorin, Michael, Siddiqui, Minhaj, Ukimura, Osamu, Gontero, Paolo, Carroll, Peter, Pinto, Peter, Mozer, Pierre, Arcot, Ro, Taneja, Samir, Ghai, Sangeet, Crouzet, Sebastian, Mehralivand, Sherif, Joniau, Steven, Shoji, Sunao, Shiraishi, Takumi, Polascik, Thomas, Shin, Toshitaka, Lindnet, Uri, Tammisetti, Varaha, van den Bos, Willemien, and Matsuoka, Yoh

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Urologic Diseases, Prostate Cancer, Clinical Research, Ablation Techniques, Aged, Aged, 80 and over, Consensus, Delphi Technique, Humans, Male, Middle Aged, Prostatic Neoplasms, Watchful Waiting, Localized prostate cancer, Focal therapy, Partial gland ablation, Active surveillance, Focal Therapy Group Authors, Urology & Nephrology, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundWith the advancement of imaging technology, focal therapy (FT) has been gaining acceptance for the treatment of select patients with localized prostate cancer (CaP). We aim to provide details of a formal physician consensus on the utilization of FT for patients with CaP who are discontinuing active surveillance (AS).MethodsA 3-stage Delphi consensus on CaP and FT was conducted. Consensus was defined as agreement by ≥80% of physicians. An in-person meeting was attended by 17 panelists to formulate the consensus statement.ResultsFifty-six respondents participated in this interdisciplinary consensus study (82% urologist, 16% radiologist, 2% radiation oncology). The participants confirmed that there is a role for FT in men discontinuing AS (48% strongly agree, 39% agree). The benefit of FT over radical therapy for men coming off AS is: less invasive (91%), has a greater likelihood to preserve erectile function (91%), has a greater likelihood to preserve urinary continence (91%), has fewer side effects (86%), and has early recovery post-treatment (80%). Patients will need to undergo mpMRI of the prostate and/or a saturation biopsy to determine if they are potential candidates for FT. Our limitations include respondent's biases and that the participants of this consensus may not represent the larger medical community.ConclusionsFT can be offered to men coming off AS between the age of 60 to 80 with grade group 2 localized cancer. This consensus from a multidisciplinary, multi-institutional, international expert panel provides a contemporary insight utilizing FT for CaP in select patients who are discontinuing AS.

Published
2021

11. Variability of the Positive Predictive Value of PI-RADS for Prostate MRI across 26 Centers: Experience of the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel

Author

Westphalen, Antonio C, McCulloch, Charles E, Anaokar, Jordan M, Arora, Sandeep, Barashi, Nimrod S, Barentsz, Jelle O, Bathala, Tharakeswara K, Bittencourt, Leonardo K, Booker, Michael T, Braxton, Vaughn G, Carroll, Peter R, Casalino, David D, Chang, Silvia D, Coakley, Fergus V, Dhatt, Ravjot, Eberhardt, Steven C, Foster, Bryan R, Froemming, Adam T, Fütterer, Jurgen J, Ganeshan, Dhakshina M, Gertner, Mark R, Mankowski Gettle, Lori, Ghai, Sangeet, Gupta, Rajan T, Hahn, Michael E, Houshyar, Roozbeh, Kim, Candice, Kim, Chan Kyo, Lall, Chandana, Margolis, Daniel JA, McRae, Stephen E, Oto, Aytekin, Parsons, Rosaleen B, Patel, Nayana U, Pinto, Peter A, Polascik, Thomas J, Spilseth, Benjamin, Starcevich, Juliana B, Tammisetti, Varaha S, Taneja, Samir S, Turkbey, Baris, Verma, Sadhna, Ward, John F, Warlick, Christopher A, Weinberger, Andrew R, Yu, Jinxing, Zagoria, Ronald J, and Rosenkrantz, Andrew B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Biomedical Imaging, Urologic Diseases, Prevention, Prostate Cancer, Aging, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Aged, Cross-Sectional Studies, Humans, Magnetic Resonance Imaging, Male, Predictive Value of Tests, Prostate, Prostatic Neoplasms, Radiology Information Systems, Reproducibility of Results, Retrospective Studies, Societies, Medical, Medical and Health Sciences, Nuclear Medicine & Medical Imaging, Clinical sciences
Abstract

Background Prostate MRI is used widely in clinical care for guiding tissue sampling, active surveillance, and staging. The Prostate Imaging Reporting and Data System (PI-RADS) helps provide a standardized probabilistic approach for identifying clinically significant prostate cancer. Despite widespread use, the variability in performance of prostate MRI across practices remains unknown. Purpose To estimate the positive predictive value (PPV) of PI-RADS for the detection of high-grade prostate cancer across imaging centers. Materials and Methods This retrospective cross-sectional study was compliant with the HIPAA. Twenty-six centers with members in the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel submitted data from men with suspected or biopsy-proven untreated prostate cancer. MRI scans were obtained between January 2015 and April 2018. This was followed with targeted biopsy. Only men with at least one MRI lesion assigned a PI-RADS score of 2-5 were included. Outcome was prostate cancer with Gleason score (GS) greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2). A mixed-model logistic regression with institution and individuals as random effects was used to estimate overall PPVs. The variability of observed PPV of PI-RADS across imaging centers was described by using the median and interquartile range. Results The authors evaluated 3449 men (mean age, 65 years ± 8 [standard deviation]) with 5082 lesions. Biopsy results showed 1698 cancers with GS greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2) in 2082 men. Across all centers, the estimated PPV was 35% (95% confidence interval [CI]: 27%, 43%) for a PI-RADS score greater than or equal to 3 and 49% (95% CI: 40%, 58%) for a PI-RADS score greater than or equal to 4. The interquartile ranges of PPV at these same PI-RADS score thresholds were 27%-44% and 27%-48%, respectively. Conclusion The positive predictive value of the Prostate Imaging and Reporting Data System was low and varied widely across centers. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Milot in this issue.

Published
2020

15. ACR Appropriateness Criteria® Acute Pyelonephritis: 2022 Update

Author

Smith, Andrew D., Nikolaidis, Paul, Khatri, Gaurav, Chong, Suzanne T., De Leon, Alberto Diaz, Ganeshan, Dhakshinamoorthy, Gore, John L., Gupta, Rajan T., Kwun, Richard, Lyshchik, Andrej, Nicola, Refky, Purysko, Andrei S., Savage, Stephen J., Taffel, Myles T., Yoo, Don C., Delaney, Erin W., and Lockhart, Mark E.

Published
2022
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16. A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND)

Author

Harrison, Michael R., Davis, Paul G., Khouri, Michel G., Bartlett, David B., Gupta, Rajan T., Armstrong, Andrew J., McNamara, Megan A., Zhang, Tian, Anand, Monika, Onyenwoke, Kelly, Edwardson, Sara, Craig, Danielle, Michalski, Meghan, Wu, Yuan, Oyekunle, Taofik, Coyne, Brian, Coburn, Aubrie, Jones, Lee W., and George, Daniel J.

Published
2022
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20. Image‐guided multiparametric magnetic resonance imaging‐transrectal ultrasound fusion biopsy augmented with a sextant versus an extended template random biopsy: Comparison of cancer detection rates, complication and functional outcomes.

Author

Adams, Eric S., Deivasigamani, Sriram, Kotamarti, Srinath, Wolf, Steven, Mottaghi, Mahdi, Aminsharifi, Ali, Taha, Terek, Seguier, Denis, Michael, Zoe, Ivey, Michael, Gupta, Rajan T., and Polascik, Thomas J.

Published
2024
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22. ACR Appropriateness Criteria® Adrenal Mass Evaluation: 2021 Update

Author

Mody, Rekha N., Remer, Erick M., Nikolaidis, Paul, Khatri, Gaurav, Dogra, Vikram S., Ganeshan, Dhakshinamoorthy, Gore, John L., Gupta, Rajan T., Heilbrun, Marta E., Lyshchik, Andrej, Mayo-Smith, William W., Purysko, Andrei S., Savage, Stephen J., Smith, Andrew D., Wang, Zhen J., Wolfman, Darcy J., Wong-You-Cheong, Jade J., Yoo, Don C., and Lockhart, Mark E.

Published
2021
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24. Successful Diagnosis and Treatment of Occult Prostate Cancer Despite Multiple Negative Prostate Biopsies and Negative Prostate MRIs

Author

Morris, Kostantinos E., Grimberg, Dominic C., Gupta, Rajan T., Pendse, Avani A., and Moul, Judd W.

Subjects
Prostate cancer -- Diagnosis -- Care and treatment, Metastasis -- Care and treatment -- Diagnosis, Magnetic resonance imaging -- Health aspects, Antigens -- Health aspects, Health
Abstract

Prostate-specific antigen (PSA) values above 100 ng/mL often suggest metastatic prostate cancer. We present the case of a patient with a PSA of 110 ng/mL, 4 negative prostate biopsies, and 4 negative prostate MRIs. After his fifth MRI revealed a PI-RADS 5 lesion, he underwent his fifth transrectal biopsy; this revealed Gleason 3 + 4 = 7. He was found to have organ-confined pT2 disease on subsequent radical prostatectomy pathology. This case highlights that there may be no PSA for which one can assume metastatic disease with certainty. Depending on life expectancy, patients with extremely elevated PSA may still warrant a full staging workup. KEY WORDS: prostate, prostate cancer, mpMRI, radical prostatectomy, PSA, PHI, Exosome, delayed diagnosis, surgical pathology, Introduction And Initial Presentation A man, aged 73 years, presented to our care in early 2021 with a prostate-specific antigen (PSA) of 110 ng/mL after 4 negative prostate biopsies and [...]

Published
2022

26. ACR Appropriateness Criteria® Renal Failure

Author

Wong-You-Cheong, Jade J., Nikolaidis, Paul, Khatri, Gaurav, Dogra, Vikram S., Ganeshan, Dhakshinamoorthy, Goldfarb, Stanley, Gore, John L., Gupta, Rajan T., Heilbrun, Marta E., Lyshchik, Andrej, Metter, Darlene F., Purysko, Andrei S., Savage, Stephen J., Smith, Andrew D., Wang, Zhen J., Wolfman, Darcy J., and Lockhart, Mark E.

Published
2021
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30. ACR Appropriateness Criteria® Indeterminate Renal Mass

Author

Wang, Zhen J., Nikolaidis, Paul, Khatri, Gaurav, Dogra, Vikram S., Ganeshan, Dhakshinamoorthy, Goldfarb, Stanley, Gore, John L., Gupta, Rajan T., Hartman, Robert P., Heilbrun, Marta E., Lyshchik, Andrej, Purysko, Andrei S., Savage, Stephen J., Smith, Andrew D., Wolfman, Darcy J., Wong-You-Cheong, Jade J., and Lockhart, Mark E.

Published
2020
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31. ACR Appropriateness Criteria® Hematuria

Author

Wolfman, Darcy J., Marko, Jamie, Nikolaidis, Paul, Khatri, Gaurav, Dogra, Vikram S., Ganeshan, Dhakshinamoorthy, Goldfarb, Stanley, Gore, John L., Gupta, Rajan T., Heilbrun, Marta E., Lyshchik, Andrej, Purysko, Andrei S., Savage, Stephen J., Smith, Andrew D., Wang, Zhen J., Wong-You-Cheong, Jade J., Yoo, Don C., and Lockhart, Mark E.

Published
2020
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33. Implementation and Impact of a Risk-Stratified Prostate Cancer Screening Algorithm as a Clinical Decision Support Tool in a Primary Care Network

Author

Shah, Anand, Polascik, Thomas J., George, Daniel J., Anderson, John, Hyslop, Terry, Ellis, Alicia M., Armstrong, Andrew J., Ferrandino, Michael, Preminger, Glenn M., Gupta, Rajan T., Lee, W. Robert, Barrett, Nadine J., Ragsdale, John, Mills, Coleman, Check, Devon K., Aminsharifi, Alireza, Schulman, Ariel, Sze, Christina, Tsivian, Efrat, Tay, Kae Jack, Patierno, Steven, Oeffinger, Kevin C., and Shah, Kevin

Published
2021
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34. Interobserver Reproducibility of the PI-RADS Version 2 Lexicon: A Multicenter Study of Six Experienced Prostate Radiologists.

Author

Rosenkrantz, Andrew B, Ginocchio, Luke A, Cornfeld, Daniel, Froemming, Adam T, Gupta, Rajan T, Turkbey, Baris, Westphalen, Antonio C, Babb, James S, and Margolis, Daniel J

Subjects
Humans, Prostatic Diseases, Organometallic Compounds, Contrast Media, Magnetic Resonance Imaging, Biopsy, Retrospective Studies, Reproducibility of Results, Adult, Aged, Middle Aged, Male, Neoplasm Grading, Practice Patterns, Physicians', Clinical Research, Biomedical Imaging, Prostate Cancer, Urologic Diseases, Cancer, Medical and Health Sciences, Nuclear Medicine & Medical Imaging
Abstract

Purpose To determine the interobserver reproducibility of the Prostate Imaging Reporting and Data System (PI-RADS) version 2 lexicon. Materials and Methods This retrospective HIPAA-compliant study was institutional review board-approved. Six radiologists from six separate institutions, all experienced in prostate magnetic resonance (MR) imaging, assessed prostate MR imaging examinations performed at a single center by using the PI-RADS lexicon. Readers were provided screen captures that denoted the location of one specific lesion per case. Analysis entailed two sessions (40 and 80 examinations per session) and an intersession training period for individualized feedback and group discussion. Percent agreement (fraction of pairwise reader combinations with concordant readings) was compared between sessions. κ coefficients were computed. Results No substantial difference in interobserver agreement was observed between sessions, and the sessions were subsequently pooled. Agreement for PI-RADS score of 4 or greater was 0.593 in peripheral zone (PZ) and 0.509 in transition zone (TZ). In PZ, reproducibility was moderate to substantial for features related to diffusion-weighted imaging (κ = 0.535-0.619); fair to moderate for features related to dynamic contrast material-enhanced (DCE) imaging (κ = 0.266-0.439); and fair for definite extraprostatic extension on T2-weighted images (κ = 0.289). In TZ, reproducibility for features related to lesion texture and margins on T2-weighted images ranged from 0.136 (moderately hypointense) to 0.529 (encapsulation). Among 63 lesions that underwent targeted biopsy, classification as PI-RADS score of 4 or greater by a majority of readers yielded tumor with a Gleason score of 3+4 or greater in 45.9% (17 of 37), without missing any tumor with a Gleason score of 3+4 or greater. Conclusion Experienced radiologists achieved moderate reproducibility for PI-RADS version 2, and neither required nor benefitted from a training session. Agreement tended to be better in PZ than TZ, although was weak for DCE in PZ. The findings may help guide future PI-RADS lexicon updates. (©) RSNA, 2016 Online supplemental material is available for this article.

Published
2016

41. The role of magnetic resonance imaging (MRI) in focal therapy for prostate cancer: recommendations from a consensus panel

Author

Muller, Berrend G, Fütterer, Jurgen J, Gupta, Rajan T, Katz, Aaron, Kirkham, Alexander, Kurhanewicz, John, Moul, Judd W, Pinto, Peter A, Rastinehad, Ardeshir R, Robertson, Cary, de la Rosette, Jean, Sanchez‐Salas, Rafael, Jones, J Stephen, Ukimura, Osamu, Verma, Sadhna, Wijkstra, Hessel, and Marberger, Michael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Prostate Cancer, Cancer, Biomedical Imaging, Urologic Diseases, Biopsy, Consensus, Humans, Magnetic Resonance Imaging, Male, Patient Selection, Practice Guidelines as Topic, Prostatic Neoplasms, Risk Assessment, Sensitivity and Specificity, Ultrasonography, Interventional, Ultrasound, High-Intensity Focused, Transrectal, United States, prostate cancer, focal therapy, consensus, multiparametric magnetic resonance imaging, prostate biopsies, Urology & Nephrology, Clinical sciences, Oncology and carcinogenesis
Abstract

ObjectiveTo establish a consensus on the utility of multiparametric magnetic resonance imaging (mpMRI) to identify patients for focal therapy.MethodsUrological surgeons, radiologists, and basic researchers, from Europe and North America participated in a consensus meeting about the use of mpMRI in focal therapy of prostate cancer. The consensus process was face-to-face and specific clinical issues were raised and discussed with agreement sought when possible. All participants are listed among the authors. Topics specifically did not include staging of prostate cancer, but rather identifying the optimal requirements for performing MRI, and the current status of optimally performed mpMRI to (i) determine focality of prostate cancer (e.g. localising small target lesions of ≥0.5 mL), (ii) to monitor and assess the outcome of focal ablation therapies, and (iii) to identify the diagnostic advantages of new MRI methods. In addition, the need for transperineal template saturation biopsies in selecting patients for focal therapy was discussed, if a high quality mpMRI is available. In other words, can mpMRI replace the role of transperineal saturation biopsies in patient selection for focal therapy?ResultsConsensus was reached on most key aspects of the meeting; however, on definition of the optimal requirements for mpMRI, there was one dissenting voice. mpMRI is the optimum approach to achieve the objectives needed for focal therapy, if made on a high quality machine (3T with/without endorectal coil or 1.5T with endorectal coil) and judged by an experienced radiologist. Structured and standardised reporting of prostate MRI is paramount. State of the art mpMRI is capable of localising small tumours for focal therapy. State of the art mpMRI is the technique of choice for follow-up of focal ablation.ConclusionsThe present evidence for MRI in focal therapy is limited. mpMRI is not accurate enough to consistently grade tumour aggressiveness. Template-guided saturation biopsies are no longer necessary when a high quality state of the art mpMRI is available; however, suspicious lesions should always be confirmed by (targeted) biopsy.

Published
2014

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