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Transformative Evidence
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 Written by Physician-Scientist
Presented by Karim Fizazi, MD, PhD
 The ESMO 2021 annual meeting’s prostate cancer mini oral session included a presentation by Dr. Karim Fizazi discussing health-related quality of life, pain, and safety outcomes in the phase 3 VISION study. [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) delivers β-particle radiation to prostate-specific membrane antigen (PSMA) expressing cells and the surrounding microenvironment.
Presented by Karim Fizazi, MD, PhD
In this presentation, Dr. Karim Fizazi discussed updated results of PEACE-1, a randomized Phase 3 trial in men with de novo metastatic castration-sensitive prostate cancer (mCSPC). This update focused on the overall survival (OS) for men treated with or without abiraterone plus prednisone (AAP).
Presented by Shahneen K. Sandhu, MBBS FRACP
In the Proffered Paper Session of the ESMO Annual Congress focusing on prostate cancer, Dr. Shahneen Sandu presented the preliminary results based on an interim analysis of the PRINCE trial assessing the role of 177-Lu-PSMA-617 in combination with pembrolizumab in men with metastatic castration-resistant prostate cancer (mCRPC).
Presented by Andrew J. Armstrong, MD
(UroToday.com) In the Proffered Paper Session of the ESMO Annual Congress focusing on prostate cancer, Dr. Andrew Armstrong presented the final overall survival analysis from the ARCHES trial of enzalutamide in men with metastatic hormone-sensitive prostate cancer (mHSPC).
Presented by Bertrand Tombal, MD, PhD,
At the ESMO 2021 annual meeting Dr. Bertrand Tombal presented a subgroup analysis of the phase 3 HERO study assessing the efficacy and safety of relugolix versus leuprolide among men with advanced prostate cancer.
Presented by Bertrand Tombal, MD, PhD
At the ESMO 2021 annual meeting, Dr. Bertrand Tombal presented a subgroup analysis of the phase 3 HERO study assessing geographical efficacy and safety of relugolix versus leuprolide among men with advanced prostate cancer.
Presented by Elena Castro, MD
In the on-demand poster session of the ESMO Annual Congress, Dr. Elena Castro presented results from the PRORADIUM cohort (NCT02925702) examining the effect of germline mutations on outcomes for patients treated with radium-223.
Presented by Alicia Morgans, MD, MPH
In the on-demand poster session of the ESMO Annual Congress, Dr. Alicia Morgans discussed a modeling analysis of cabazitaxel compared to repeat treatment with an androgen receptor targeting agent (ARTA) among patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel and the alternative ARTA.
Presented by Michael Morris, MD
In the on-demand poster session of the ESMO Annual Congress, Dr. Morris provided a summary of the PSMAfore trial in progress (NCT04689828). This study examines the role of [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) in taxane-naïve patients with mCRPC.
Presented by Sanam Seyedian, MD
The role in the surveillance of patients following intravesical therapy has not been established. In a podium presentation at the American Urologic Association Virtual Annual Meeting, Dr. Seyedian and colleagues presented the results of their analysis examining this question.
Presented by Karim Chamie, MD
The AUA 2021 virtual annual meeting included a late-breaking abstract session with a presentation by Dr. Karim Chamie discussing long-term recurrence free survival following UGN-101 treatment for low-grade upper tract urothelial carcinoma.
Presented by Andrei Iagaru, MD
The AUA annual meeting included a late-breaking abstract session with a presentation by Dr. Andrei Iagaru discussing the prospective evaluation of 18F-DCFPyL PET/CT in biochemically recurrent prostate cancer and the detection of extra-pelvic oligometastases.
Presented by Alberto Briganti, MD, PhD
The plenary session at the 2021 AUA virtual annual meeting included the European Association of Urology lecture by Dr. Alberto Briganti who discussed clinically relevant questions in the management of locally advanced and oligometastatic prostate cancer.
Presented by Alejandro R. Rodriguez, MD
At the plenary session of the AUA 2021 virtual annual meeting, Dr. Alejandro Rodriguez provided the Confederacion Americana de Urologia (CAU) lecture discussing controversies and challenges of penile cancer management.
Presented by Fred Saad, MD, FRCS

In a podium presentation at the American Urologic Association (AUA) Virtual Annual Meeting, Dr. Fred Saad and colleagues presented an exploratory analysis of the efficacy of olaparib versus either abiraterone or enzalutamide, given a potential difference in the efficacy of NHA sequencing.

 

Presented by Eila C. Skinner, MD
The 2021 Ramon Guiteras Lecture at the 2021 AUA annual meeting was provided by Dr. Eila Skinner who provided her perspective on three decades of bladder cancer treatment and advances.
Presented by James McKiernan, MD
The 2021 AUA annual meeting included a guideline amendment update for non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC) provided by Dr. James McKiernan.
Presented by Brian Chapin, MD
 The AUA annual meeting included a State-of-the-Art Lecture by Dr. Brian Chapin who discussed personalized medicine in the management of prostate cancer across the patient care continuum.
Presented by Cora Sternberg, MD, FACP
In this rapid review for the American Urologic Association (AUA) plenary session, Dr. Cora Sternberg summarized the current status of first and second-line therapy for advanced and metastatic urothelial cancer – while also touching on changes that are upcoming.
Presented by Chris H. Bangma, MD, PhD
In this presentation, Dr. Chris Bagma, Professor of Urology at Erasmus MC, focused on anxiety and quality-of-life for men on active surveillance for prostate cancer. First, he started by reviewing active surveillance. Active surveillance (AS) is a treatment option for low-risk prostate cancer per the EAU and AUA guidelines. 
Presented by William Thomas Lowrance, MD, MPH, MBA
In this plenary session, Dr. William Thomas Lowrance summarized the 2021 AUA/ASTRO/SUO guidelines on advanced prostate cancer, with key take-home points highlighted. The full 2 part guidelines1,2 can be found online at They are also published in the Journal of Urology.
Presented by Stephen A. Boorjian, MD
The AUA annual meeting’s evolving landscape of advanced prostate cancer treatment session included a talk by Dr. Stephen Boorjian discussing bone health and radionuclide therapy. Dr. Boorjian notes that there are several clinically relevant aspects of bone health in CRPC including (i) the issue of bone loss, given that the median age of patients with CRPC is similar to the age of at-risk patients for physiologic/age-related decrease in bone mineral density
Presented by Leonard G. Gomella, MD
The AUA annual meeting’s evolving landscape of advanced prostate cancer treatment session included a talk by Dr. Leonard Gomella discussing genetic testing in advanced prostate cancer. Dr. Gomella notes that there have been rapid advances in prostate cancer genetic testing, reflected in changes made to the NCCN guidelines from 2016-2020.
Presented by Stephen A. Boorjian, MD
The Society of Urologic Oncology held an associated session at the American Urologic Association Virtual Annual Meeting entitled “The Evolving Landscape of Advanced Prostate Cancer Treatment: A Guidelines and Case-Based Discussion.” Dr. Stephen Boorjian began this session with a talk focusing on the identification of patients with high-risk prostate cancer and the initial management of those with biochemical recurrence following therapy.
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),
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. 
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, 
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.
Library Resources
State of the Evidence Review Articles
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,