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Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

19th Annual New York GU Cancers Congress™

, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, discussed the highly anticipated 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, underscored the curative potential of adjuvant therapy in kidney cancer.

During the discussion, the experts highlight the abstracts that have caught their eye and offer their predictions on the data that could reshape the landscape of genitourinary oncology.

Several intriguing abstracts are highlighted, with a focus on the evolving role of immunotherapy and the potential for novel combinations.

Phase 3 PDIGREE trial (NCT03793166): Immunotherapy plus nivolumab (Opdivo) and ipilimumab (Yervoy) followed by nivolumab alone or nivolumab with cabozantinib (Cabometyx) for patients with advanced kidney cancer. This will be presented by Tian Zhang, MD, MHS, on May 31 from 1:27-1:33 pm CDT.

Phase 1b STELLAR-002 trial (NCT05176483): Zanzalintinib plus nivolumab and relatlimab in patients with advanced solid tumors. This will be presented by Benjamin Garmezy, MD, in a poster presentation on June 2 at 2:30 pm CDT.

The Bupathi and Garmezy suggest we should be on the lookout for data that could refine treatment algorithms and identify new biomarkers to guide therapy selection.

The potential impact of neoadjuvant therapy and the role of circulating tumor DNA (ctDNA) analysis were key discussion points. The experts anticipated seeing updates from ongoing trials exploring the utility of ctDNA as a predictive and prognostic biomarker, potentially allowing for more personalized treatment approaches.

Phase 3 NIAGARA trial (NCT03732677): ctDNA will be assessed in those who received perioperative durvalumab (Imfinzi) for muscle-invasive bladder cancer. This will be presented by Thomas Pwles, MD, PhD, FCRP, on June 1 from 10:45-10:57 am CDT.

Phase 3 Checkmate901 (NCT03036098): Nivolumab plus ipilimumab vs gemcitabine/carboplatin in patients who are previously untreated with unresectable or metastatic urothelial carcinoma. This will be presented by Michael Simon Van Der Heijden, MD, PhD, on June 1 from 9:45-9:57 am CDT.

A significant portion of the discussion revolves around prostate cancer, with several potentially practice-changing abstracts generating excitement.

Artificial intelligence (AI): The use of a multimodal AI model to determine the benefit from a second-generation androgen receptor pathway inhibitor for patients who are high-risk and have non-metastatic prostate cancer and were enrolled on the phase 2/3 STAMPEDE trial (NCT00268476). This will be presented by Nicholas David James, PhD, FRCP, MBBS, on June 3 from 9:57-10:09 am CDT.

Radiation therapy: A phase 3 trial assessing CAN-2409 plus prodrug and standard of care external beam radiation therapy in patients with newly diagnosed localized prostate cancer. This will be presented by Theodore L. De-Weese, MD, on June 3 from 9:45-9:57 am CDT.

Furthermore, the conversation touched upon anticipated phase 3 data in hormone-sensitive prostate cancer. Specifically, there’s excitement around upcoming results for patients with high-risk or high-volume metastatic hormone-sensitive prostate cancer harboring 

 mutations. This data could be practice-changing and offer a new therapeutic avenue for this specific subset of patients.

Beyond these specific disease areas, the podcast highlighted the broader themes expected at 2025 ASCO, including the continued development and refinement of immunotherapy, the integration of multimodal AI in oncology, and the ongoing investigation of novel targets, like TROP2 inhibitors.

Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, highlight exciting trials in the genitourinary cancer space expected to be presented at 2025 ASCO. 

A Sneak Peek at 2025 ASCO From the GU Perspective

Maha H. Hussain, MD, and Sarah E. Fenton, MD, PhD, spoke with 

 about developments in their careers and the evolution of research in the genitourinary oncology (GU) field. Additionally, they discussed their personal experiences in the field, which ranged from applying key pieces of advice from former mentors, handling challenges, and maintaining a healthy work/life balance.

Hussain is a Genevieve E. Teuton Professor of Medicine at Northwestern Medicine, and her mentee and fellow colleague, Fenton, is an assistant professor of Medicine at Northwestern Medicine.

The conversation partly focused on how the GU oncology landscape has evolved over time. According to Hussain, funding for new research and clinical trials has grown due to partnerships with pharmaceutical companies, which has accompanied a growth in median survival for patients with metastatic castration-resistant and metastatic hormone-sensitive prostate cancer. Looking ahead, Fenton said she hopes to see a greater proportion of patients achieve improved disease control, thereby leading to more treatment discontinuations or longer treatment-free intervals.

Additionally, Fenton described some of the advice she received that impacted the trajectory of her career and helped her decide to specialize in GU oncology.

“You need to stick with things that are important to you, worth your time, and are going to help people,” Fenton said. “That is the best piece of advice that Maha has given me as I’ve been moving through and thinking about what projects I’m going to start and where I am going to work hard.”

Hussain and Fenton also spoke about some of the personal challenges they have encountered in genitourinary oncology, including the difficulty of balancing their personal lives with professional aspirations. Both spoke to the importance and possibility of caring for their families while establishing priorities for their work.

“You can parallel-track your career and your personal life. I would say motherhood is wonderful; it’s a wonderful opportunity to be a mother,” Hussain said. “At the same time, it was a wonderful opportunity to be a physician and move the field there and work hard. Don’t forget that your personal life is very important because a happy personal life also reflects on your work life.”

Leaders in genitourinary oncology spoke about key research advances as well as personal experiences in navigating the field.

Finding Ways to Break the Mold in GU Oncology

CancerNetwork examines research from the October issue of the journal 

Value of Geriatric Assessment in Patients With Genitourinary Carcinoma

” alongside lead author of the substudy, which was based on the previously published PERATECS3 project (NCT01278537), Quirin Zangl, MD, from the Department of Neuroanesthesia, at the Christian Doppler Hospital in Salzburg, Austria.

The research featured 111 patients with urogenital carcinomas with the goal of evaluating comprehensive geriatric assessment tools that may be utilized to better guide these individuals perioperatively. Patients were divided into 2 groups, consisting of prostate cancer (n = 88) and distal urinary tract cancer (n = 29). In this episode, Zangl discussed the relationships between comprehensive geriatric assessment tools and complications, hospital duration, death rate, and baseline characteristics were analyzed.

Don’t forget to subscribe to the "Oncology Peer Review On-The-Go" podcast on Apple Podcasts, Spotify or anywhere podcasts are available.

Lead author, Quirin Zangl, MD, spoke with CancerNetwork about research published in the journal ONCOLOGY focusing on the importance comprehensive geriatric assessment tools for patients with genitourinary carcinomas.

Oncology Peer Review On-The-Go: Value of Geriatric Assessment in Patients With Genitourinary Carcinomas

Today we are discussing immunotherapy approaches for the treatment of advanced urothelial cancer with Dr. Petros Grivas, MD, PhD, a medical oncologist who focuses on genitourinary cancers at the Seattle Cancer Care Alliance and the University of Washington. Grivas is an associate professor and clinical director of the Genitourinary Cancers Program at the University of Washington, and associate member of the Fred Hutchinson Cancer Research Center in Seattle. 

There have been at least five Food and Drug Administration (FDA) approvals of immunotherapies, and specifically of immune checkpoint inhibitor antibodies, for urothelial cancer. Could you briefly go through the agents now available for treatment and which patients are eligible?

I would start by saying that we have experienced a revolution in the treatment landscape for advanced urothelial cancer in the last few years and this has led to the FDA approval of five distinct immune checkpoint inhibitors that inhibit the PD1/PDL1 axis of the immune system. These five agents are pembrolizumab, atezolizumab, durvalumab, avelumab and nivolumab.

All of these agents are approved for patients who have advanced urothelial cancer, meaning locally advanced/unresectable or metastatic disease and have progressed despite treatment with platinum-based chemotherapy. These agents are approved by the FDA in what we call the “salvage setting” after prior platinum-based chemotherapy.

One of those agents, pembrolizumab, has shown overall survival benefit, as a primary endpoint of a phase 3III trial, compared to salvage chemotherapy in patients who progressed on platinum-based chemotherapy. The other agents were approved based on phase II trials. It is worth mentioning that another agent, atezolizumab, was also tested in a phase III trial that showed that in “all-comers," meaning in the entire study population, there was overall survival benefit compared to salvage chemotherapy.

However, this was not the primary endpoint; the primary endpoint was overall survival in the subset of patients who had higher PD-L1 expression and this particular primary endpoint was not met in this IMvigor211 trial.

So overall, we have five agents approved in this particular salvage setting, and one of them has Level 1 evidence based on NCCN [National Comprehensive Cancer Network] guidelines based on the phase III Keynote 045 trial, that compared pembrolizumab vs salvage chemotherapy. However, all of these therapy options are approved and available in this setting, but there is no data to use one after progression on another checkpoint inhibitor.

Moreover, in the first-line setting, especially for cisplatin-unfit patients, meaning patients who cannot safely receive cisplatin in the first-line, chemotherapy-naÃ¯ve for advanced disease setting, two of these agents are FDA approved: atezolizumab and pembrolizumab based on single arm, phase II studies (IMvigor 210, cohort 1, for atezolizumab, and Keynote 052 for pembrolizumab). These agents were initially approved regardless of tumor tissue PD-L1 expression.

However, more recently, around May and June of 2018, there were discussions with the FDA and EMA (European Medicines Agency) in Europe that ultimately led to the modification of the label of these two agents in the first-line setting. The chemotherapy naÃ¯ve cisplatin-unfit patients that restricted the use of these two checkpoint inhibitors to patients with high PD-L1 expression based on the companion corresponding assay for each agent.

For example, for pembrolizumab, this is the Agilent/Daco 22C3 assay, and for atezolizumab, the Ventana SP142 assay. However, in the US based on FDA clarification, if a patient is very frail and unfit for carboplatin, so not a good fit for any platinum-based chemotherapy, there is no need to check PD-L1 expression in these patients and they could get either approved checkpoint inhibitor in the first-line setting regardless of PD-L1 expression.

These are the approved agents, but there are a plethora of ongoing clinical trials that are looking at combination therapies in advanced urothelial cancer, while also looking at biomarkers. There is also evaluation of those and other immune checkpoint inhibitors in earlier disease settings, including the adjuvant and neoadjuvant settings as well as the non-muscle invasive bladder cancer setting.

You mentioned cisplatin-based chemotherapy has been the standard of care for urothelial carcinoma. In the context of the labels for the approved checkpoint inhibitors, how do you view the role of these agents in treatment? Are there also other options for the same line of therapy? How do you choose an immunotherapy vs a different type of treatment for patients?

There are a few points to make here. Number one is that in the front-line setting in the locally advanced/unresectable or metastatic urothelial cancer, the standard of care is cisplatin-based chemotherapy. Of course, we always want to do clinical trials and this is the optimal way to go regardless of treatment setting. But in the absence of trials, cisplatin chemotherapy, usually gemcitabine-cisplatin, or less frequently, accelerated, dose dense MVAC [methotrexate, vinblastine, doxorubicin, cisplatin] is used in this first-line setting.

The patients who cannot get cisplatin have the option of getting non-cisplatin chemotherapy and usually many of those patients end up getting carboplatin/gemcitabine or a checkpoint inhibitor, pembrolizumab or atezolizumab, which, as we just discussed, are approved in this first-line “chemotherapy naive for advanced disease” setting for cisplatin unfit patients. The decision depends on the fitness, candidacy, eligibility for cisplatin, and the availability of clinical trials. Right now, in advanced urothelial cancer we have chemotherapy and immunotherapy as approved options.

We don't have any other agents approved yet, however, we have many ongoing clinical trials looking at antibody drug conjugates. Agents like enfortumab vedotin and sacituzumab govitecan, which are being tested in very interesting phase II and III trials, with prior, early-phase, trial data looking very promising.

There are also targeted therapy trials, including inhibitors against FGF receptor, PARP, HER2, and other molecular targets. I think that these trials are very interesting, and hopefully we will have more agents approved in the future. Until then, I think clinical trials is the optimal way to go.

To summarize, cisplatin-based chemotherapy upfront is the standard of care for fit patients. For cisplatin-unfit patients we have either other chemotherapy, for example carboplatin/gemcitabine, or the two approved checkpoint inhibitors as first line therapy, based on the details we discussed above.

If a patient is progressing on platinum-based chemotherapy, a clinical trial is again the way to go. Outside of clinical trials, we have the five FDA-approved checkpoint inhibitors, with pembrolizumab having Level 1 evidence in this salvage therapy setting.

You mentioned that there are clinical trials of combinations and there are trials testing these immunotherapy agents in earlier disease settings, and also biomarkers. Of all of these questions that you and your colleagues are addressing with respect to checkpoint inhibitor antibodies, are there one or two questions that you could highlight?

I think there are multiple, very interesting clinical trials, really a huge list, and I don’t want to leave anything out. But overall, the main questions we are trying to answer are in the first-line setting, is chemotherapy or immunotherapy the way to start for advanced urothelial cancer?

In that context, there are four large, phase III trials asking this question of chemotherapy vs immunotherapy in the front-line setting. Two of these trials are asking an additional question, which is whether the combination of chemotherapy and immunotherapy is better than chemotherapy or immunotherapy alone. I think these trials may potentially impact the treatment landscape.

There are also two very important “switch maintenance” trials. One is a phase III trial that is testing an anti-PDL1 agent, avelumab), after 4 to 6 cycles of front-line platinum-based chemotherapy, with no progression. Patients get randomized to avelumab and best supportive care vs best supportive care alone.

There is also a phase II trial that has a very similar design that is randomizing patients to pembrolizumab vs placebo with a crossover design after front-line platinum-based chemotherapy to evaluate this “switch maintenance” question, whether this sequencing of therapies is of benefit. As I mentioned, there are numerous other trials with a plethora of agents, checkpoint inhibitors plus chemotherapy, radiation therapy, targeted therapies, antibody drug conjugates, vaccines, other immune related molecules, cytokines, epigenetic modulators, anti-angiogenesis agents, etc., that are all very interesting.

These trials are trying to build upon what we have already seen with checkpoint inhibitors and are trying to prospectively evaluate the clinical utility of biomarkers. The question is, could we try to select the right patients for the right treatment in the future? Because “one size may not fit all” and patient selection is critical. So far, with the exception of tumor tissue PD-L1 in the front-line setting, we do not have clinically useful biomarkers in advanced urothelial cancer.

There is definitely the opportunity to try to identify clinically useful biomarkers to select patients, but this requires multi-center collaborations and prospective validation of candidate biomarkers across clinical trials. This is something very hard to do, but we should all push through. Candidate biomarkers span across tumor tissue, urine and blood-based biomarkers, which are interesting and worth exploring further.

Thank you so much for joining us today Dr. Grivas.

My pleasure. Hopefully we will experience many more advances in the near future in the field of urothelial cancer with new agents and biomarkers.

Grivas has done consulting with Genentech, Merck & Co., Pfizer, Bristol-Myers Squibb, AstraZeneca, Biocept, Clovis Oncology, EMD Serono, Seattle Genetics, Foundation Medicine, Driver Inc., QED Therapeutics, Heron Therapeutics, and Janssen within the past 2 years. He was previously involved in an educational, unbranded program with Genentech and Bristol-Myers Squibb. His institutions have received research support from Genentech, Bayer, Merck & Co., Mirati, OncoGenex, Bavarian Nordic, Pfizer, AstraZeneca, Clovis Oncology, and Immunomedics.

Cancer Network spoke with Dr. Petros Grivas about emerging immunotherapy approaches for the treatment of advanced urothelial cancer.

Emerging Immunotherapy Approaches For Urothelial Cancer

Ahead of the American Association for Cancer Research annual meeting, being held April 14–18 in Chicago, Illinois, we spoke with Elizabeth Plimack, MD. Dr. Plimack is chief of the division of genitourinary medical oncology and director of genitourinary clinical research at the Fox Chase Cancer Center in Philadelphia, where she specializes in the treatment of genitourinary cancers, including bladder cancer. At the meeting, she will be discussing recent advances in systemic therapy for bladder cancer, in a presentation entitled, “Systemic Therapy for Locally Advanced and Metastatic Bladder Cancer: A Rapidly Evolving Landscape.”

First, can you talk about the standard surgical and therapy options for locally advanced disease that have been around now for a while, and then how these contrast with the options for metastatic bladder cancer patients?

Sure. Bladder cancer has a variety of presentations. And in fact, the majority of people who develop bladder cancer have what is called noninvasive or localized bladder cancer, which can be treated with topical instillations and procedures done to the bladder itself.

Beyond that, there is a subset of patients with muscle-invasive bladder cancer, and that is what we talk about as locally advanced bladder cancer. Those patients can be cured of their cancer, but it requires what we call multimodality treatment with both chemotherapy and surgery and, in some cases, chemotherapy with radiation. The difference between that state and the metastatic state is that the locally advanced state we are treating with a curative intent and in the metastatic setting, although treatable, the cancer is not curable.

So the goals of care are different and the treatment paradigm is different. I can speak first about best practices for patients with locally advanced muscle-invasive bladder cancer. The treatment algorithm for those patients is fairly well defined, with multiple guideline groups-NCCN [National Comprehensive Cancer Network], the AUA [American Urological Association], and the European groups recommending chemotherapy prior to surgery to increase the chance of a cure, defined as being disease-free at 5 years. We know that adding chemotherapy prior to treatment (typically surgery), helps. Recently, novel developments suggested that chemotherapy alone may be curative for a subset of patients, perhaps 10% to 30% of patients, and we are finding trials in that space to allow for patients to keep their bladders when chemotherapy is curative. I will be speaking about that in my talk at AACR.

What are some of the new treatment modalities that have recently been approved for either locally advanced or metastatic bladder cancer?

In locally advanced disease, we have developed [potential therapeutic regimens] and have started to enroll in clinical trials, looking to identify complete responders to chemotherapy and allowing for bladder-sparing. Those are the trials that are ongoing but have not yielded data yet. We are waiting for data on the 

 a trial that randomized patients to gemcitabine and cisplatin chemotherapy or dose-dense chemotherapy, and that study will provide really important data on more modern chemotherapy regimens in this curative situation, and [on] response rates and cure rates.

But also, this trial will help us define a number of biomarkers, including the ‘COXEN’ biomarker for which the trial was designed. And again, we are waiting for data on all of those trials. In the metastatic setting, it’s a different story. We have had an explosion of data over the last 3 years, which has defined and changed how we treat metastatic patients. And I will be speaking about that in my talk at AACR as well.

Just as an overview, prior to 2016, the last time a drug was approved for metastatic bladder cancer was in the 1970s, when cisplatin and doxorubicin were approved, which is a really long drought that we had of treatment for metastatic disease. We’ve been dependent entirely on chemotherapy up until that time.

Since 2016, a number of checkpoint inhibitors have been approved in the US, and those are now used in both the frontline and second-line setting for patients with metastatic bladder cancer. I will be speaking in my talk about the comparative data across these different agents, their toxicity profile and what questions still remain in terms of guiding their use. A couple of key points to make about the use of these novel checkpoint inhibitors in bladder cancer once it’s metastatic: There are five of these agents approved; all of them inhibit either PD-1 [programmed cell death 1]or PD-L1 [programmed death-ligand 1] and are all in the same pathway. Those drugs are pemrolizumab, atezolizumab, avelumab, durvalumab, and nivolumab.

While it seems like we have five new options, they really all do the same thing and there is no evidence that after we treat with one, treating with another one of those five will yield responses. So what we have that is growing is a group of patients who have had chemotherapy and had [treatment with] a checkpoint inhibitor who now need a novel therapy. I am particularly excited about data emerging in that space, helping patients either reinvigorate their immune response against their cancer or treat with a non-immunotherapy targeted agent such as a VEGF [vascular endothelial growth factor] inhibitor, an inhibitor of NECTIN-4, a novel antibody drug conjugate; that is currently in clinical trials.

In terms of reinvigorating the immune response for patients whose tumors have evaded their single-agent PD-1 or PD-L1 therapy, there are a couple of really interesting approaches. One is with epacadostat plus pembrolizumab. Epacadostat makes the immune microenvironment more appropriate for immune surveillance and [achieving] an antitumor effect. Then a study we are running here, funded by Stand Up 2 Cancer, is looking at hypomethylation to reinvigorate the immune response both by changing the biology of T-lymphocytes and the immune microenvironment. So we are excited about all of those trials, which are all currently enrolling-and many are in phase III already.

Are there additional therapies you haven’t mentioned, with different mechanisms of action, that are still in development and appear to be promising?

There are many. What is exciting for us in treating urothelial cancer is that this disease was one that was usually avoided in trying to develop new drugs; most of the development went to the more common tumor types. The truth is that bladder cancer is very common and has been very responsive to many treatments. So there has been an influx of interest in developing novel agents for this disease, which is great.

One area that we will be looking at closely is earlier stages of disease, so non–muscle-invasive bladder cancer. Again, most of these patients can be treated with treatments that are directly just to the bladder, but there are a lot of rationales for trying both immunotherapies and targeted agents in this space. Again, ideally, the goal is to cure patients of their bladder cancer with systemic therapy, and make sure that they don’t go to surgery.

Now, if the disease cannot be controlled topically, those patients end up with surgical removal of their bladder. Research in that space is interesting and promising, and some of that data will be presented at AACR.

American Association for Cancer Research Annual Meeting (AACR)

Dr. Elizabeth Plimack discusses her 2018 AACR meeting presentation on recent advances in systemic therapy for bladder cancer.

Systemic Therapy for Advanced Bladder Cancer Evolves

The American Society of Clinical Oncology (ASCO) 

 the first guidance, a provisional clinical opinion (PCO), on second-line hormonal therapy for chemotherapy-naive castration-resistant prostate cancer (CRPC). Today we are speaking about the guideline with one of its authors, Eric Singer, MD, a urologic oncologist at Rutgers Cancer Institute of New Jersey. 

Can you talk about why this guideline is particularly timely?

 We have the good fortune in the management of prostate cancer to have new agents available, and in hearing from practitioners, patients, and patient advocates, I think there was a need to put more of a framework in place in terms of when these agents should be used and which men are the ideal candidates. ASCO has a very robust clinical practice guidelines committee and puts out guidelines regularly across the entire spectrum of cancer treatments, and so this seemed like a great opportunity for us to do one on second-line hormonal therapy for advanced CRPC, because there are now these options available.

How was the PCO developed? What goes into deciding what is actually in the guideline?

ASCO has both guidelines and PCOs, and the goal for both is to provide the best evidence available. It’s a very robust, detailed process. There is an incredibly talented ASCO guideline staff, expert oncologists who form the clinical guideline committee membership, and individual guideline authorship teams. We do a detailed literature review, pulling published studies and presentations at national meetings, and go through all of the different levels of evidence to try to put together the most impactful and strongest evidence in support of doing something or sometimes 

The goal is to make it clear who we should be thinking about using an intervention in, when it should be used, how it should be used, and what the tradeoffs are in terms of toxicity vs increases or improvements in survival. We might perhaps address preventing complications or side effects, disease progression, metastasis, while also keeping in mind palliation and being thoughtful about financial toxicity-what impact would this treatment have on the patient in terms of out-of-pocket costs.

So we try to take all of those divergent pieces and interests and synthesize it down for our end users to something very readable, usable, and evidence-based.

What is the weight of this PCO, how important is this for clinical care? Can you help put that into context?

The PCO-not quite the full weight of a formal guideline-was developed to try to be more nimble and more responsive to emerging evidence as the field continues to develop and mature. So in situations like CRPC where there are many studies, new agents coming out, new major reports being issued very regularly, the PCO allows us to still be able to get some guidance out there in a thoughtful and thorough manner-even though we know that the rate and pace of the field will change so that we will need to update this fairly regularly.

Can you talk about the major recommendations within the PCO?

Some of the major recommendations from this PCO talk about when we should think about implementing second-line hormonal therapy in men with CRPC. Essentially, in men who do not have evidence of metastatic disease, who are M0, the thought is that we would typically not suggest treatment-unless they are at very high risk of developing metastasis because of a very rapidly progressing prostate-specific antigen (PSA) velocity.

Even in men who do have rapid PSA doubling time, if they don't have evidence of metastatic disease, we really want to counsel them carefully and make sure they fully understand the limitations of the evidence in terms of what benefit they might get from starting second-line hormonal therapy vs the side effects and costs that go along with it. And of course these are men who, very often, are eligible for clinical trials, and we certainly want to support men enrolling in clinical trials to try to answer these questions in a more robust fashion.

In terms of men who do have metastatic disease, so M1a or M1s, we would think about offering them second-line hormonal therapy-that would typically be abiraterone acetate (with prednisone) or enzalutamide, as both of these drugs have been shown to meet all of the endpoints that were specified in the clinical trials that looked at them. So they both increase the time to radiographic progression-free survival and improve survival. Those are the two agents that are currently being used in men with M1a and M1s CRPC.

Anything else you would like to add, maybe the best way for clinicians to utilize the PCO?

I think one of the most important goals of the PCO is to help inform shared decision-making between our doctors and our patients. The PCO is intended to help synthesize all of the information out there so patients understand the potential benefits as well as the known risks that go along with starting a new line of therapy, and to remind all of our providers that palliation, attention to symptoms, and symptom management should be brought in very early on in the disease.

In this interview we discuss the ASCO provisional clinical opinion on second-line hormonal therapy for chemotherapy-naive castration-resistant prostate cancer.

Genitourinary Cancers

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