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Level 1 Evidence: Practice-Changing Clinical Trials View all
PYLARIFY (18F DCFPyL) in Prostate Cancer
PURPOSE: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule PSMA-targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging.
JAVELIN Bladder 100 Trial
BACKGROUND Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.
PROfound Study

We previously reported that olaparib led to significantly longer imaging-based progression-free survival than the physician's choice of enzalutamide or abiraterone among men with metastatic castration-resistant prostate cancer who had qualifying alterations in homologous recombination repair genes and whose disease had progressed during previous treatment with a next-generation hormonal agent.

HERO Study
Injectable luteinizing hormone–releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known.
Conference Coverage
Conference Highlights from Recent Conference Coverage
Presented by Fernando López-Campos, MD
The availability of multiple treatments for metastatic castration-resistant prostate cancer (mCRPC) mandates the need to identify, as well as validate, prognostic and predictive factors applicable to clinical practice. Given the complexity of therapeutic decision-making in these patients, there is a need to determine which patients would be most likely to benefit from a given treatment more rapidly and facilitate optimized decisions on therapeutic sequencing. 
Presented by Silke Gillessen, MD
Beginning with the introduction of docetaxel for metastatic castration resistant prostate cancer (mCRPC) in 2004, there has been a dramatic and rapid proliferation of systemic therapy options in advanced prostate cancer including a number of novel hormonal therapies (including abiraterone acetate and enzalutamide), second-line chemotherapy (cabazitaxel), bone-targeting agents (radium-223) and other targeted agents (including olaparib, rucaparib, and pembrolizumab), each of which has proven survival benefits.
Presented by Mary-Ellen Taplin, MD
Following Micheal Morris’s presentation of the results of the phase III VISION trial of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer in the Plenary Session of the 2021 ASCO, Dr. Mary-Ellen Taplin from the Dana Farber Cancer Institute provided a discussant overview of these data and helped to contextualize how we may apply them to our practices.
Presented by Micheal Morris, MD
In a plenary presentation at the 2021 ASCO Annual Meeting, Dr. Morris presented the first results of the VISION trial, a phase III study assessing lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer.
Presented by Daniel J. George, MD
There are a number of treatment options that have been shown to improve overall survival in mCSPC, including docetaxel and novel hormonal therapies including abiraterone acetate, enzalutamide, and apalutamide. While these agents have proven beneficial in clinical trials, improvement in population-level outcomes depends on their widespread adoption. Dr. Daniel George and colleagues assessed the real-world utilization of effective combination therapies in the first-line treatment of mCSPC in oncology practice.
Presented by Andrew J. Armstrong, MD
The phase III ARCHES trial, along with the ENZAMET trial, provided the basis for enzalutamide’s approval in this disease space. However, data from each of these trials have suggested that the benefit of treatment intensification may differ on the basis of disease extent. To explore this further, Dr. Andrew Armstrong presented a post-hoc analysis of the ARCHES trial aimed at evaluating the efficacy of enzalutamide with ADT in men with bone oligometastatic metastatic hormone-sensitive prostate cancer (mHSPC) compared to polymetastatic mHSPC.
Presented by Dean F. Bajorin, MD
For patients with muscle-invasive bladder cancer who are eligible for curative-intent treatment, cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) is a standard of care with improved pathologic response and overall survival (OS) compared to RC alone.
Presented by Arlene O. Siefker-Radtke, MD
In this presentation, Arlene O. Siefker-Radtke, MD provided a discussion on two presentations on Enfortumab Vedotin (EV)  in previously treated urothelial cancer. Primary results of EV-301 and EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.
Presented by Anne K. Schuckman, MD
The optimizing personalized management of non-muscle-invasive bladder cancer session at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) included a presentation from Dr. Anne Schuckman discussing which patients with high-risk non-muscle-invasive bladder cancer may benefit from radical cystectomy.
Presented by Brian I. Rini, MD
The activity of tivozanib after axitinib has not been previously defined, and as such the activity of tivozanib after prior therapy types including axitinib is of clinical relevance. At the 2021 ASCO GU, Dr. Brian Rini and colleagues presented results of the TIVO-3 trial testing tivozanib in patients with advanced RCC who had progressed after prior axitinib treatment.
Presented by David Cella, PhD
The treatment landscape for first-line therapy among patients with metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 2 years. In 2018, publication of the CheckMate214 data demonstrated a survival benefit for patients treated with nivolumab and ipilimumab compared with sunitinib in intermediate and poor-risk mRCC, ushering in the immunotherapy era for mRCC.
Presented by Michael J. Morris, MD
The case presented was that of a 54-year-old man with an extensive family history of cancer. His mother died from ovarian cancer, his father had prostate cancer and died of colon cancer, his brother developed kidney and prostate cancer, and his sister had breast and ovarian cancer.
Presented by Tamer Khashab, MD
In this study, Dr. Khashab presented genomic data derived from a retrospective analysis of patients treated at a community-focused academic healthcare system in Texas that serves a higher percentage of Hispanic and African American patients with prostate cancer. 
Presented by Petros Grivas, MD, Ph.D.
In a presentation at the 2021 ASCO GU, Dr. Grivas described the design of the confirmatory phase III trial, TROPiCS-04. TROPiCS-04 is a global, multicenter, open-label, randomized controlled trial, performed among patients with locally advanced unresectable or metastatic urothelial carcinoma.
Presented by Lawrence Mbuagbaw, MD, MPH, Ph.D.
At the 2021 ASCO GU, Dr. Lawrence Mbuagbaw and colleagues presented results of their real-world study evaluating clinical outcomes of patients when Radium-223 was used early (second-line) or late (third or later lines) among men with mCRPC.
Presented by Daniel J. George, MD
Dr. Daniel George and colleagues presented a subgroup analysis assessing the impact of concomitant prostate cancer therapy on the safety and efficacy of the oral GnRH receptor antagonist relugolix versus leuprolide in men with advanced prostate cancer. 
Presented by Ian Davis, MBBS, PhD, FRACP, FAChPM
The 2020 Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Mini Annual Scientific Meeting featured a session on ANZUP trial updates, including an update of the critical Phase III ENZAMET trial provided by Drs. Ian Davis, Arun Azad, and Lisa Horvath.
Presented by Andrea Necchi, MD,
In an oral presentation in a session examining neoadjuvant versus adjuvant strategies in locally advanced bladder cancer at the 12th European Multidisciplinary Congress on Urological Cancers (EMUC), Dr. Andrea Necchi led a discussion of neoadjuvant strategies in advanced bladder cancer.
Presented by Tamim Niazi, MDCM
Patients with high-risk localized prostate cancer who receive radiotherapy for management of their primary disease also receive LHRH analog therapy for at least one year or longer.
Presented by Michiel S. van der Heijden, MD, PhD
Platinum-based chemotherapy is the mainstay of first-line treatment for medically eligible patients with advanced urothelial carcinoma (UC). Unfortunately, up to 50% of patients are unable to receive cisplatin, and disease progression often develops even for patients who receive cisplatin.
Presented by Casilda Llacer Perez, MD
The CARD trial was a randomized open-label study of cabazitaxel versus the alternative anti-androgen therapy in patients with metastatic castration resistant prostate cancer (mCRPC) who had progressed on docetaxel and also progressed on either enzalutamide or abiraterone within 12 months of therapy initiation.
Presented by Cora Sternberg, MD
Many immunotherapy strategies have been pursued in metastatic castration-resistant prostate cancer (mCRPC) to date, with the dendritic cell vaccine sipuleucel-T representing the only approved therapy in this space.
Presented by Ben Tran, MBBS, FRACP
There is an urgency to develop therapies with novel mechanisms of action to treat prostate cancers resistant to chemohormonal and radiation therapies. Unfortunately, to date, immune therapies have offered limited efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).
Presented by Yohann Loriot, MD, MSc
Treatment options for advanced urothelial cancer that has progressed through platinum chemotherapy and immune checkpoint blockade consist of (1) single agent chemotherapy, (2) FGFR inhibitor therapyfor tumors harboring susceptible alterations, and (3) the antibody-drug conjugate enfortumab vedotin.
Presented by Toni K. Choueiri, MD
The treatment landscape for first-line therapy among patients with metastatic renal cell carcinoma (mRCC) has changed dramatically over the past 2 years.
Presented by Ronald De Wit PhD
(UroToday.com) It is well known that inflammation is a hallmark of cancer, harboring a critical role in tumor development and metastatic progression in many cancers, including prostate cancer.
Presented by Thomas Powles, MBBS, MRCP, MD
Advanced urothelial carcinoma resulted in over 200,000 deaths across the world in 2018. Though the majority of patients eligible for such therapy respond to platinum-based chemotherapy, disease progression occurs relatively quickly and half or less of patients receive second line treatment.
Presented by Michael J. Morris, MD
Radium-223 is a bone-targeted alpha therapy that prolongs survival in patients with symptomatic metastatic castration-resistant prostate cancer (mCRPC) to the bone based on results from the phase III ALSYMPCA trial.
Presented by Michael J. Morris, MD
Biochemical recurrence is not an infrequent occurrence following local therapy for prostate cancer, utilizing either radiotherapy or radical prostatectomy. Following biochemical relapse, patients may have disease either locally in the pelvic or more distantly.
Presented by Bertrand F. Tombal, MD, PhD
The CARD trial, initially presented at ESMO 2019 and subsequently published, addressed the question of appropriate third line therapy in mCRPC for patients who had previously received docetaxel and also progressed on an anti-androgen therapy (either abiraterone or enzalutamide) within 12 months.
Presented by Cora N. Sternberg, MD, FACP
Prostate cancer is the 2nd and 3rd leading cause of cancer death in the USA and in Europe, respectively,1,2 with most deaths occurring in men over the age of 75. In men with metastatic castrate-resistant prostate cancer (mCRPC), there are multiple treatment options available today,
Presented by  Antoine Thiery-Vuillemin, MD, PhD
The randomized Phase 3 PROfound trial showed that olaparib significantly prolonged radiographic progression-free survival compared with physician’s choice of new hormonal agent (enzalutamide or abiraterone) in men with mCRPC and HRR gene alterations, whose disease had progressed on prior new hormonal agent.
Everyday Urology™ – Oncology Insights
Review Articles Focusing on Urologic Oncology View all
Everyday Urology™ – Oncology Insights
Everyday Urology: Volume 5, Issue 4
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The State-of-the-Evidence in Brief Reviews by Experts
Written by Christopher J.D. Wallis, MD, PhD, & Zachary Klaassen, MD, MSc,
June 22, 2021
In spite of the rapid progress and  many exciting advances in the treatment of metastatic castration-resistant prostate cancer (mCRPC) over the past few years, the disease remains incurable with a median overall survival of 12-35 months.
Written by Christopher J.D. Wallis, MD, PhD, & Zachary Klaassen, MD, MSc
June 22, 2021
An accurate assessment of the extent of disease is critical to the care of patients with cancer, across the natural history of disease including initial evaluation, following local treatment, and assessing response to systemic therapy. Thus, improvements in radiographic imaging may revolutionize
Written by Charles Ryan, MD
June 30, 2020
June 26, 2020, marked the 20th anniversary of the publication of the first working draft from the Human Genome Project. At a special White House event to commemorate the results of this 10-year public effort (it was really more like 50 years since the discovery of DNA, but I digress), then-President Bill Clinton called the project “the most wondrous map ever created by humankind”, and touted its promise to detect, prevent, and treat disease.
June 24, 2020
Despite the recent disruptions in health care delivery due to the COVID-19 pandemic, patients at risk for developing prostate cancer as well as those diagnosed with prostate cancer still deserve timely and optimal decision making. Unfortunately, the uncertainty of the pandemic requires urologists to adopt innovative strategies in order to prioritize patient care while being mindful to mitigate the potential infectious risks of COVID-19 to their patients as well as to their healthcare team.
Written by Arpit Rao, MBBS and Charles Ryan, MD
June 29, 2020
In this review, we will summarize the current indications for PARP inhibitor monotherapies and combination(s), review data from clinical trials in prostate cancer, discuss management of commonly encountered side effects, and highlight exciting clinical research on expanding the role of PARP inhibitors in prostate cancer.
Written by Veda N. Giri, MD
June 29, 2020
Understanding the role of germline testing in prostate cancer is now critical to urologic and oncology practice for metastatic castration-resistant prostate cancer. Here, we will address who should be considered for germline testing, when germline testing may influence treatment and management, and how to implement germline testing involving provider practices and genetic counseling.
Written by Patrick G. Pilié, MD
June 29, 2020
Men with advanced prostate cancer have a 10-15% risk of carrying a hereditary, or germline, variant in a DNA damage response gene. Pathogenic or deleterious variants in these same DNA damage response genes can also be found at the somatic, or tumor-associated level, in up to 25% of metastatic castrate-resistant prostate cancer.
Written by Christopher J.D. Wallis, MD, PhD and Zachary Klaassen, MD, MSc
June 17, 2020
Prostate cancer is a clinically heterogeneous disease with many patients having an indolent course requiring no interventions and others who either present with or progress to metastasis. While underlying dominant driving mutations are not widespread, there have been a number of key genomic mutations that have been consistently identified in prostate cancer patients, across the disease spectrum
Written by Zachary Klaassen, MD, MSc and Christopher J.D. Wallis, MD, PhD
May 14, 2020
The coronavirus has the potential to impact the integrity and patient safety of ongoing trials as well as increase the operational burden on trial programs, therefore potentially limiting access to trials and new therapies for oncology patients. Opportunities for clinical trial enrollment may still be provided to patients during the COVID-19 outbreak, but likely require thorough evaluation on a case-by-case basis.
May 20, 2020
The purpose of this document is to describe the appropriate use of imaging in the diagnostic evaluation of patients with BCR after definitive primary treatment. The imaging modalities that were considered included CT, bone scan, and the U.S. Food and Drug Administration (FDA)–approved PET radiotracers that track malignancy-induced lipogenesis (11C-choline) and amino acid metabolism (18F-fluciclovine). 
Written by Christopher J.D. Wallis, MD, PhD and Zachary Klaassen, MD, MSc
April 20, 2020

The rapid spread of Coronavirus Disease 2019 (COVID-19), caused by the betacoronavirus SARS-CoV-2, throughout the world has had dramatic effects on healthcare systems with impacts far beyond the patients actually infected with COVID-19. Patients who manifest severe forms of COVID-19 requiring respiratory support typically require this for prolonged durations,