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Contemporary Treatment Strategies for ADT in prostate cancer

European Society for Medical Oncology 2020

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Transformative Evidence
Level 1 Evidence: Practice-Changing Clinical Trials View all
CARD Trial
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.
CARD Trial
Presented by Ronald de Wit, MD, PhD
Taxanes (docetaxel, cabazitaxel) and androgen-signaling-targeted inhibitors (abiraterone, enzalutamide) have shown survival benefits in metastatic castration resistant  prostate cancer (mCRPC), however until recently the optimal sequence of these treatments was unclear.
CARD Trial
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.
CARD Trial
Presented by Mihaela Aldea, MD, PhD
Up to 30% of metastatic castration-resistant prostate cancer (mCRPC) men harbor DNA damage repair defects and may benefit from poly-ADP ribose polymerase (PARP) inhibitors after abiraterone/enzalutamide and docetaxel failure. Cabazitaxel was recently shown to improve overall survival in this population
CARD Trial

In the CARD study, cabazitaxel significantly improved radiographic progression-free survival and overall survival versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen signalling-targeted inhibitor.

CARD Trial
Presented by Gero Kramer, MD
 The CARD study was a multicenter, randomized, open-label study enrolling patients with metastatic castrate-resistant prostate cancer who progressed in less than 12 months on prior androgen receptor-targeted agent1 (before or after docetaxel therapy).
PROSPER Trial
Presented by Cora N. Sternberg, MD, FACP
(UroToday.com) There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide 
CARD Trial
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.
CARD Trial
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,
PROSPER Trial
Presented by Cora N. Sternberg, MD, FACP
Enzalutamide is an FDA approved androgen receptor antagonist used in the treatment of essentially every phase of advanced prostate cancer, from metastatic hormone-sensitive prostate cancer to metastatic and non-metastatic castration-resistant prostate cancer.
PROSPER Trial
Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.
CARD Trial
As medical oncologists, urologists, radiation oncologists, and other clinicians, we find ourselves feeling very comfortable understanding Kaplan Meier survival curves and forest plots describing subgroups in the setting of different treatments. We review CTCAE adverse event data, drilling down on the 10% of adverse effects that happen most commonly, and nearly always arrive at the conclusion that “such and such treatment is relatively well tolerated”.
ENZAMET Trial
Presented by Alicia Morgans, MD, MPH
San Francisco, California (UroToday.com) Dr. Alicia Morgans, Associate Professor and Medical Oncologist at Northwestern University Feinberg School of Medicine, presented some of the most influential articles from the past year in the field of prostate cancer research from a medical oncology perspective.
CARD Trial
Presented by Karim Fizazi, MD, PhD
San Francisco, California (UroToday.com) The survival outcomes of the CARD trial, a practice-informing study of men with pre-treated metastatic castration-resistant prostate cancer (mCRPC), have previously been reported.
PROSPER Trial
San Francisco, CA (UroToday.com) -- Astellas Pharma Inc. and Pfizer Inc. announced the results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
CARD Trial

The robust outcome of CARD with a hazard ratio (HR) for radiographic progression-free survival (rPFS) 0.54 in favor of cabazitaxel allows meaningful subgroup analyses. Preplanned subgroups of particular interest and that, importantly, retained statistical significance including the time to failure on the first androgen receptor targeted agents (ARTA) (0-6 months, 6-12 months) and the docetaxel- first ARTA sequence.

CARD Trial
Presented by Silke Gillessen, MD
Barcelona, Spain (UroToday.com) Dr. De Wit’s presentation of the positive CARD trial, Dr. Silke Gillessen provided an invited discussion regarding the implications and practice-changing measures that result from these findings.
CARD Trial

The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear.

CARD Trial
Presented by Ronald De Wit, MD, PhD
Barcelona, Spain (UroToday.com) Multiple therapeutic options have been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC), including the second-generation anti-androgens abiraterone and enzalutamide, and chemotherapy with docetaxel or cabazitaxel.
ENZAMET Trial
Presented by Henrik Gronberg, MD, PhD
Barcelona, Spain (UroToday.com) At the prostate cancer poster discussion at ESMO 2019, Dr. Henrik Gronberg provided a discussion of three important abstracts: the updated STAMPEDE “M1|RT Comparison”, as well as patient reported outcomes from both ENZAMET and TITAN.
ENZAMET Trial
Presented by Martin R. Stockler, MBBS(Hons) MSc(Clin Epi) FRACP
Barcelona, Spain (UroToday.com)  At 2019 ASCO meeting, Davis and colleagues previously reported that treatment with enzalutamide rather than an older non-steroidal anti-androgen (bicalutamide, nilutamide, or flutamide), resulted in longer overall survival 
ENZAMET Trial
San Francisco, CA USA (UroToday.com) -- Astellas Pharma Inc. and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI®(enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC).
ENZAMET Trial
Presented by Tanya B. Dorff, MD
Chicago, IL (UroToday.com) The presentation of ENZAMET, overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial, by Christopher Sweeney, MBBS, was followed by Tanya B. Dorff, MD, of City of Hope Cancer Center,
ENZAMET Trial
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Abiraterone and docetaxel are both standard of care options for available for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the United States. 
ENZAMET Trial
BACKGROUND: Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.
ENZAMET Trial
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Testosterone suppression is the backbone of treatment for metastatic hormone-sensitive prostate cancer (mHSPC), however, until 2014, testosterone suppression +/- standard nonsteroidal antiandrogen was the only therapy available. 
PROSPER Trial

Men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising prostate-specific antigen (PSA) level are at high risk for metastasis. We hypothesized that enzalutamide, which prolongs overall survival among patients with metastatic, castration-resistant prostate cancer, would delay metastasis in men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level.

PROSPER Trial

In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study.

PROSPER Trial
Presented by Karim Fizazi, MD, Ph.D
Munich, Germany (UroToday.com) During GU ASCO 2018, Dr. Hussain presented the results of PROSPER (NCT02003924), a phase III randomized, double-blind, placebo-controlled study of enzalutamide in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC)1.
PROSPER Trial
Presented by Gerhardt Attard, MD, FRCP, Ph.D
Chicago, IL (UroToday.com) At the 2018 GU ASCO meeting in San Francisco, Maha Hussain, MD presented the results of PROSPER, a phase III randomized controlled trial assigning 1,401 men with non-metastatic CRPC (M0 CRPC) 2:1 to enzalutamide (160 mg) or placebo.
PROSPER Trial
Presented by Fred Saad, MD, FRCS
San Francisco, CA (UroToday.com) The PROSPER trial (NCT02003924) compared the efficacy and safety of enzalutamide (ENZA) 160 mg/day vs placebo (PBO) in asymptomatic men with non-metastatic castration-resistant prostate cancer with prostate-specific antigen doubling time of 10 months.
PROSPER Trial
Presented by Neal Shore, MD
San Francisco, CA USA (UroToday.com) Earlier this year, at the 2018 GU ASCO conference, the results of two major clinical trials assessing androgen-targeted therapies (ART) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC or M0 CRPC)
PROSPER Trial
Presented by Bernard Tombal, MD
Copenhagen, Denmark (UroToday.com) At GU ASCO 2018, Dr. Maha Hussain presented the data from the PROSPER study, which was an incredibly important study looking at the role for enzalutamide (ENZA) in the setting of non-metastatic castration-resistant prostate cancer (nmCRPC).
PROSPER Trial
Presented by Cora Sternberg, MD
Copenhagen, Denmark (UroToday.com)  Androgen deprivation therapy (ADT) is the standard treatment recommended for hormone-sensitive prostate cancer. Since their initial introduction as alternatives to docetaxel for metastatic castrate resistant prostate cancer (mCRPC)
PROSPER Trial
Presented by Philip W. Kantoff, MD
San Francisco, CA (UroToday.com) The management of metastatic prostate cancer (PCa) continues to change in rapid succession. While we were once reliant on androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer (hsPCa) and docetaxel alone
PROSPER Trial
Presented by Maha Hussain, MD, FACP, FASCO
San Francisco, CA (UroToday.com) Dr. Maha Hussain provided the first presentation of the phase III randomized double-blind controlled trial, the following men were eligible for inclusion
PROSPER Trial
Truckee, CA (UroToday.com) - Pfizer Inc. and Astellas Pharma Inc. announced that the Phase 3 PROSPER trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS). The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.
Conference Coverage
Recent data from conferences worldwide
Presented by André Deschamps, MD
(UroToday.com) André Deschamps, MD, presented a study assessing the quality of life of patients after being treated for prostate cancer. The study involved a 20-minute online survey intended for patients with prostate cancer who received treatment in Europe. It is an observational one-arm study, aiming to examine the quality of life of prostate cancer patients in Europe.
Presented by Elizabeth Wulff-Burchfield, MD
(UroToday.com) Elizabeth Wulff-Burchfield, MD, is a medical oncologist specializing in palliative care. At the 2020 Society of Urologic Oncology Virtual Webcast, she discussed supportive and palliative care for urologists.
Presented by Kathryn Hacker Gessner, MD, Ph.D.
Washington, DC (UroToday.com) There is an increasing recognition that postoperative opioid prescriptions are contributing to the opioid crisis in the United States. This is in part due to the diversion of excess opioid medications,
Presented by Neeraj Agarwal, MD
Barcelona, Spain (UroToday.com) Androgen deprivation therapy (ADT) has long been considered the standard of care for patients with metastatic prostate cancer, however recent studies have shown improved survival outcomes by adding additional agents.
Presented by Henrik Gronberg, MD, PhD
Barcelona, Spain (UroToday.com) At the prostate cancer poster discussion at ESMO 2019, Dr. Henrik Gronberg provided a discussion of three important abstracts: the updated STAMPEDE “M1|RT Comparison”, as well as patient reported outcomes from both ENZAMET and TITAN.
Presented by Sumanta K. Pal, MD
Chicago, IL (UroToday.com) The landscape of systemic therapy for metastatic renal cell carcinoma (mRCC) is rapidly changing. Beyond the addition of immune checkpoint inhibitor combinations (nivo/ipi), additional TKI’s (cabozantinib),
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Written by Diane K. Newman, DNP, ANP-BC, FAAN
March 4, 2020
Intermittent catheterization (IC) can be indicated as treatment for voiding problems due to disturbances or injuries to the nervous system, non-neurogenic bladder dysfunction, or intravesical obstruction with incomplete bladder emptying.

Intermittent catheterization should be performed in the presence of a residual urine volume and symptoms or complications arising from this residual volume of urine.
Written by Diane K. Newman, DNP, ANP-BC, FAAN
March 4, 2020
Intermittent catheterization (IC) is the preferred procedure for people with incomplete bladder emptying not satisfactorily managed by other methods. Complications and adverse events can arise in both men and women but are seen especially in male patients performing intermittent self-catheterization long-term. Urethral/scrotal events can include bleeding, urethritis, stricture, the creation of a false passage, and epididymitis. Bladder-related events can cause UTIs, bleeding, and stones. The most frequent complication of IC is urinary tract infection (UTI).
Written by Diane K. Newman, DNP, ANP-BC, FAAN
March 3, 2020
The number of catheter types and designs has increased with the advancement of new technology. This has added complexity to the catheterization process for both the nurse and the patient. Catheter types are now gender specific, acknowledging the anatomical differences in urethral length between men and women. Standard male catheter length is 16” (~40cm), whereas female catheters range in length from 6-12”.  Pediatric lengths are 6-10”.  Many women find that shorter catheters do not shift and are easier to grasp and insert.
Written by Diane K. Newman, DNP, ANP-BC, FAAN
November 29, 2019
Intermittent catheterization (IC) is the insertion and removal of a catheter several times a day to empty the bladder. This type of catheterization is used to drain urine from a bladder that is not emptying adequately or from a surgically created channel that connects the bladder with the abdominal surface (such as Mitrofanoff continent urinary diversion). Intermittent catheterization is widely advocated as an effective bladder management strategy for patients with incomplete bladder emptying due to idiopathic or neurogenic detrusor (bladder) dysfunction (NDO).
Written by Diane K. Newman, DNP, ANP-BC, FAAN
February 5, 2020
Medicare Changes Reimbursement Policy to End Re-use of Intermittent Catheters.  This change allows for up to 6 catheter changes a day in hopes to stop re-use of FDA labeled "single-use" catheters. The old policy made individuals sterilize and clean their catheters any way they knew how which lets a very high-risk opportunity to have the individual get infected with catheter-associated bacteria to arise.  No longer will catheter users suffer from severely painful UTIs.
Written by Diane K. Newman, DNP, ANP-BC, FAAN
February 1, 2013
Patients may be concerned about the discomfort associated with intermittent catheterization, the need to maintain privacy, the fear of performing the catheterization, and the inability to find a clean and appropriate toilet when traveling outside their home. Clinicians need to consider these patient concerns in their teaching and recommend possible strategies.