Topic: Bladder Cancer

Current Status of PSMA Diagnostics

by Jeremie Calais, MD, MSc | Aug 2021

Jeremie Calais, MD, MSc, Assistant Professor and Director of the Clinical Research Program in the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at UCLA, discusses PSMA diagnostics and compares imaging modalities to establish which modality is ideal for prostate cancer staging. He shares the FDA guidelines, stating that Ga 68 PSMA-11 is to be used for patients with prostate cancer (PCa) with suspected metastasis who are candidates for definitive therapy, and with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Dr. Calais summarizes two trials used to support FDA approval of the diagnostic agent, including one on biochemical recurrence localization showing an overall detection rate of 75%, and another on primary nodal N1 staging that shows a sensitivity of 40% and a specificity of 95% for Ga 68 PSMA-11. Dr. Calais also notes the weaknesses of PSMA-11, including PET/CT’s inability to detect microscopic cancer cells, the way bone trauma in the ribs can lead to false positives, the challenge of accurately reading faint uptake lymph nodes, and how urine can disrupt analysis of the prostate fossa. Dr. Calais then compares PSMA against fluciclovine, finding that PSMA has a 30% higher detection rate; and against conventional imaging, finding that PSMA has a 27% higher rate of accuracy, as well as higher sensitivity and specificity. He also compares PSMA and local staging with MRI, highlighting a study on intra-prostatic tumor detection that shows a negligible difference in detection rates, as well as two studies on PSMA PET for biopsy guidance that show PSMA PET’s effectiveness in detecting especially challenging cancer. Dr. Calais concludes that PSMA PET/CT should replace other imaging modalities for prostate cancer staging and should be used as a complement to MRI for intra-prostatic tumor detection and staging.

Next Generation Imaging for Prostate Cancer

by Phillip J. Koo, MD | Aug 2021

Phillip J. Koo, MD, Division Chief of Diagnostic Imaging and Northwest Region Oncology Physician Executive at the Banner MD Anderson Cancer Center in Phoenix, Arizona, gives an overview of the current state of next generation imaging (NGI) for prostate cancer and how it compares to conventional imaging, i.e., bone scans and CT scans. He begins by noting that while there are strengths to conventional imaging and the NCCN clinical guidelines still recommend its use, it misses a lot of cancer, especially in patients with low PSA or biochemical recurrence (BCR). Dr. Koo suggests that NGI is to conventional imaging as a high-definition television is to a conventional one: both show a picture, but one shows a clearer one. He briefly looks at how NGI for prostate cancer works, explaining that NGI takes advantage of unique biological aspects of prostate cancer carcinogenesis and that increased metabolism and vascular changes in prostate cancer cells can be evaluated with radiolabeled analogs of choline, acetate, glucose, amino acids, and nucleotides. Dr. Koo then goes over the different approved NGI PET/CT options, including 11C-choline, 18F-fluciclovine, 68Ga-PSMA-11, and PyLARIFY PSMA. He particularly focuses on the 2 PSMA ligands, since data indicates that PSMA PET/CT performs better than anything used in the past, detecting more cancer at lower PSA levels than other techniques and in places where prostate cancer has rarely been seen before. Dr. Koo notes that PSMA is not infallible though, highlighting a study showing that while 68Ga-PSMA-11 generally has better detection rates than fluciclovine, fluciclovine has a higher detection rate in the prostate bed, suggesting that each radiopharmaceutical has its own strengths and weaknesses. He concludes with a summary of when and how clinicians should use NGI, emphasizing that NGI is here to stay and the field of urologic oncology should be prepared for rapid change.

Urine Biomarkers for the Detection of Urothelial Carcinoma

by Siamak Daneshmand, MD | Jul 2021

Siamak Daneshmand, MD, Associate Professor of Urology and Director of Clinical Research at the University of Southern California discusses the ability of urinary markers to rule out bladder cancer and decrease the frequency of and need for cystoscopy and cytology. He goes over the limitations and adverse effects of cystoscopy and cytology before summarizing the findings of several studies looking at different urinary biomarkers for bladder cancer, including Cxbladder, Bladder EpiCheck, Bladder CARE™, and Decipher Bladder.

Blue Light vs. White Light Cystoscopy for NMIBC

by Sanjay G. Patel, MD | Jul 2021

Sanjay G. Patel, MD, Assistant Professor of Urology at the University of Oklahoma in Oklahoma City, considers the benefits of blue light versus white light cystoscopy for non-muscle-invasive bladder cancer (NMIBC) imaging. He goes over the importance of good imaging in minimizing progression and recurrence, then looks at the evidence behind blue light cystoscopy, highlighting the improved rates of detection of Ta, T1, and CIS tumors compared to white light cystoscopy. Dr. Patel also notes that these improved rates of detection appear to translate to reduced rates of recurrence and progression as well as increased time to recurrence and progression. He concludes by looking at guideline recommendations on when to use blue light cystoscopy.

A Review of AUA / SUO / ASTRO Guidelines for MIBC

by Michael S. Cookson, MD, MMHC | Jun 2021

Michael S. Cookson, MD, MMHC, Professor and Chairman of the Department of Urology at the University of Oklahoma Health Sciences Center, summarizes the updated AUA/SUO/ASTRO guideline for the treatment of muscle-invasive bladder cancer (MIBC), a particularly deadly and difficult-to-treat disease. He explains the purpose and methodology of the guideline, summarizes its contents, and makes a note of recent and ongoing research in the areas of chemotherapy, extended pelvic lymphadenectomy, and bladder preservation that may change the guidelines in the future.

Bladder Cancer Journal Vol. 7, Issue 2

by Bladder Cancer Journal | Jun 2021

Rationale for Randomized Clinical Trials Investigating the Potential of BCG Vaccination in...

Industry Perspective: The Role of URO17 ^TM in the Diagnosis and Management of Bladder Cancer

by John Cucci | Jun 2021

John Cucci, an executive at Acupath Laboratories, Inc., introduces the URO17TM antibody, a promising adjunct to cytology for bladder cancer diagnosis. Mr. Cucci explains that while cytology is the standard technique used in diagnosing bladder cancer and has a high positive predictive value, its sensitivity is low. URO17TM detects the expression of keratin-17, a protein strongly associated with bladder cancer, and has greater than 95% sensitivity and specificity. Mr. Cucci goes over the promising early results for URO17TM, as discussed in several papers, and notes that it has been given an expedited clinical trial process by the FDA. He also looks at its potential clinical utilization, both as a screening tool for hematuria patients and as a long-term monitoring tool for bladder cancer patients after they complete therapy. He emphasizes that URO17TM can cheaply and effectively provide additional and reliable information for the pathologist and urologist to more appropriately rule in or out additional diagnostic work-up in patients. Mr. Cucci concludes by presenting a graphic of the URO17TM diagnosis categories and risk meter.

Industry Perspective: Panel Discussion on Cxbladder Genomic Urine Test for Bladder Cancer

by Siamak Daneshmand, MD | May 2021

Siamak Daneshmand, MD, Associate Professor of Urology and Director of Clinical Research at the University of Southern California (USC), along with Anne Schuckman, MD, Assistant Professor of Clinical Urology at the USC, and Sima P. Porten MD, MPH, Associate Professor at the USC participated in a panel discussion on the Cxbladder Genomic Urine Test for Bladder Cancer at the 5th Annual International Bladder Cancer Update. Dr. Daneshmand reviews a research study that audited the clinical utility of the Cxbladder monitor assay and found that it accurately ruled out patients who did not have recurrent UC, enabling low risk patients to undergo cystoscopy at a longer-than-recommended interval, thereby reducing the cystoscopy burden by 39%. He then asks Drs. Porten and Schuckman questions about their experience with Cxbladder, leading the two to discuss ideal patient populations for Cxbladder, in-home sampling procedures, and situations wherein Cxbladder is most effective.

Bladder Cancer Journal Vol. 7, Issue 1

by Bladder Cancer Journal | Apr 2021

Tumor Subtyping: Making Sense of Heterogeneity with a Goal Toward Treatment ABSTRACT: BACKGROUND:...

Neoadjuvant Cisplatin-Based Chemotherapy for Muscle-Invasive Bladder Cancer

by Robert R. Dreicer, MD, MS, MACP, FASCO | Mar 2021

Robert Dreicer, MD, MS, MACP, FASCO, Associate Director for Clinical Research and the Deputy Director of the University of Virginia Cancer Center, discusses phase 3 study evidence in support of cisplatin-based chemo which he argues is a secure alternative to immune-checkpoint inhibition, a more experimental treatment. He begins by paralleling support of immune-checkpoint inhibition to other oncological examples of physician claims of “I already know the answer.” Dr. Dreicer reflects on the 90s, specifically on the recommendation of high dose chemo for advanced breast cancer prior to the completion of studies. Once the studies were completed it became clear that high dose chemo did not demonstrate an improvement in treatment and may in fact have proved itself mostly harmful. He continues by reviewing a randomized trial comparing long-term survival results of patients treated with gemcitabine plus cisplatin against methotrexate, vinblastine, doxorubicin, and cisplatin in patients with bladder cancer. The trial found that cisplatin-based chemo had a 15.3% response rate. Dr. Dreicer overviews a phase 3 trial which found that cisplatin-based therapy reduced risk of death by 16%, corresponding to an increase in 10-year survival from 30% to 36%. He concludes with an argument for cisplatin-based treatment due to the availability of higher-quality evidence for its use than immune-checkpoint inhibition.

Neoadjuvant Immune-Checkpoint Inhibition for Muscle-Invasive Bladder Cancer

by Petros Grivas, MD, PhD | Feb 2021

Petros Grivas, MD, PhD, Associate Professor of Oncology at the University of Washington School of Medicine in Seattle, argues for the use of immune-checkpoint inhibition over cisplatin-based chemotherapy for muscle-invasive bladder cancer (MIBC) based on promising level 1 evidence. He begins with an overview of the PURE-01 trial, which found that single-agent pembrolizumab safely achieved a pTO of 42% and a down-staging rate of 54%. Dr. Grivas continues by discussing the possibility of imaging endpoint use, reaching the conclusion that more validation is necessary before progress can be made in this area. He then returns to the PURE-01 trial, reviewing the surgical safety data which demonstrate high-grade complications post-pembrolizumab in 34% of patients, a significant minority. Dr. Grivas follows this by looking at the wider landscape of phase 2 trials in MIBC beyond just PURE-01, noting that they have shown promising pathologic complete response rates and rates of pathologic downstaging to non-muscle invasive disease. He looks to the future, suggesting that with more data and validation physicians will be able to treat patients based on their individual biology. Dr. Grivas concludes by arguing that it may be possible to use immune-checkpoint inhibition in patients who are unfit for cisplatin or to even avoid using cisplatin altogether, but notes that there is a need for more high-quality studies to inform discussions.

Bladder Cancer Journal Vol. 6, Issue 4

by Bladder Cancer Journal | Dec 2020

Upregulated FGFR3 signaling in NMIBC and MIBC, the diagnosis and management of checkpoint inhibitor side effects in bladder cancer patients, the etiology of treatment delays in patients receiving neoadjuvant chemotherapy for MIBC, and 25-year trends in stage-specific incidence rates for bladder cancer.

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