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Clinical Focus

Howard I. Scher, MD; Scott T. Tagawa, MD, MS, FACP; Mary-Ellen Taplin, MD

Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?

, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer. He also highlights the recent Northwestern-led course, “Enhancing Recruitment of Ethnic Minorities in Cancer Clinical Trials,” which took place on February 16, 2024. Murphy is a prostate cancer disparities researcher and a urologist at Northwestern University Feinberg School of Medicine in Chicago, Illinois.

During the discussion, Murphy provides some advice for researchers looking to increase diversity in their trials. He also references a study in which 64% of Black patients indicated that they would be willing to discuss clinical trials in prostate cancer, compared with 82% of White patients.

 While there is a difference, Murphy notes that the percentage of more than half of Black patients being willing to discuss clinical trials is not insignificant, and the data supports the idea of clinicians continuing to make the ask to their patients in order to help increase diversity in prostate cancer trials.

Murphy ends the discussion by sharing some of his thoughts on future work building on the Northwestern-led course, such as a session focused on mock recruitments with patients who have previously enrolled in clinical trials.

Don’t forget to subscribe to Speaking of Urology® on 

, or anywhere that podcasts are available.

1. Senft N, Hamel LM, Manning MA, et al. Willingness to discuss clinical trials among Black vs White men with prostate cancer. 

. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697

In this podcast episode, Adam B. Murphy, MD, MBA, MSCI, discusses the need to increase diversity in clinical trials, specifically focusing on studies in prostate cancer.

Dr. Murphy on increasing diversity in cancer clinical trials 

On an episode of Cleveland Clinic’s Cancer Advances podcast, host Dale Shepard, MD, PhD, talked with Zeyad Schwen, MD, about the use of focal therapy to treat patients with localized prostate cancer.

Schwen, who is a urologic oncologist at Cleveland Clinic, covers these topics:

The difference between traditional treatments and focal therapies

Factors that make a patient a good candidate for focal therapy

Focal procedures, including Nanoknife, high-intensity focused ultrasound and cryotherapy

Clinical trials devoted to focal therapies

Zeyad Schwen, MD, a urologic oncologist at Cleveland Clinic, discusses how patient factors and cancer characteristics are key to deciding between focal therapies and whole gland treatment for prostate cancer. 

Dr. Schwen on focal therapies for prostate cancer

In this episode of Speaking of Urology®, 

, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection. Albala is the chief of urology at Crouse Hospital in Syracuse, New York, and Punnen is an associate professor of urologic oncology and an associate professor and vice chair of research at the Desai Sethi Urology Institute at the University of Miami in Florida.

This discussion originally took place during a live X (formerly Twitter) Spaces event held by Urology Times. In this exclusive interview, Albala and Punnen discussed the significance of advances such as liquid biopsies in prostate cancer, reviewed the current liquid biopsy tests available, and shared their own clinical experiences with the tests in their practice. They also highlighted data on the ExoDx prostate test from studies of clinical utility and validation studies.

Albala and Punnen ended their discussion by highlighting current education gaps surrounding the use of biomarker tests in practice and their predictions for the future of precision medicine.

In this episode, David M. Albala, MD, and Sanoj Punnen, MD, discuss precision medicine and the use of biomarker tests in prostate cancer screening and detection.

Speaking of Urology: Liquid biopsy in prostate cancer 

 (NCT04384770), which compared Magnetic Resonance Imaging-guided stereotactic body radiotherapy with Computed Tomography-guided stereotactic body radiotherapy in localized prostate cancer. Kishan is an associate professor of radiation oncology and urology and the chief of genitourinary oncology for radiation oncology at University of California, Los Angeles. 

Don’t forget to subscribe to Speaking of Urology

Amar Kishan, MD, highlights findings showing that MRI-guided SBRT is superior to CT-guided SBRT in localized prostate cancer.

Dr. Kishan highlights findings from the MIRAGE trial in prostate cancer

® spoke with Dr. Aaron Laviana, who discusses decisional regret in patients with prostate cancer. Laviana is an assistant professor of surgery and perioperative care and a courtesy faculty member of the department of oncology at The University of Texas at Austin Dell Medical School.

“Localized prostate cancer is a very complicated disease space,” says Aaron A. Laviana, MD, MBA.

Dr. Laviana on decisional regret after prostate cancer treatment

®Assistant Editor Janelle Hart spoke with 

. She discusses the findings of a recent 

 study, “Representation in Online Prostate Cancer Content Lacks Racial and Ethnic Diversity: Implications for Black and Latinx Men.” More specifically, she explains how these findings emphasize the need for content creators to focus more on equity, diversity, and inclusion when it comes to online medical literature. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine in New York City, New York.

“The current landscape of online materials about prostate cancer is generally pretty bleak,” says Stacy Loeb, MD, PhD, MSc.

Study finds lack of Black and Latinx representation in online prostate cancer literature

® Assistant Editor Janelle Hart spoke with 

 She discusses the role that high-intensity focused ultrasound (HIFU) has played among other minimally invasive and robotic technologies to mitigate the side effects and complications of treatment for prostate cancer, compared toe other treatment options. Linehan is an associate professor of urology and urologic oncology at the John Wayne Cancer Institute in Santa Monica, California.

“It's really become the epicenter of all the surgeries that we do in urology,” says Jennifer Linehan, MD.

Emerging HIFU technology shows promise in men with prostate cancer

 He discusses how even though there are stigmas surrounding active surveillance, a lot of research actually suggests that this form of care is preferred in patients with prostate cancer. Therefore, he emphasizes that this treatment method should be counseled accordingly by clinicians. Ehdaie is a urologic surgeon at the Memorial Sloan Kettering Cancer Center, New York City, New York.

“It doesn't need to be surgery or radiation. Setting that stage, really focusing on those conversations, using the appropriate tools that we've grasped from behavioral psychologists that are being used by negotiation specialists, are critical in medicine,” says Behfar Ehdaie, MD, MPH.

Destigmatizing Urology: Dr. Ehdaie discusses active surveillance

. She discusses the benefits of plant-based diets given the promising findings of the prospective study, “Association of plant-based diet index with prostate cancer risk,” published recently in the 

. Loeb is a professor in the departments of urology and population health at the NYU Grossman School of Medicine, New York City, New York.

“We find that consuming more healthy, plant-based foods is associated with a lower risk of aggressive and lethal prostate cancer, and has many other health benefits, too,” says Stacy Loeb, MD, PhD, MSc.

Dr. Loeb on the association between plant-based diets and prostate cancer risk

 He discusses how his new technology, The PrecisionPoint Transperineal Access System, is used for detecting prostate cancer in patients. Matthew J. Allaway, MD, is the founder and president of Perinealogic and a urologist and managing partner at Urology Associates, Cumberland, Maryland.

“We need to do a better job sampling the prostate,” says Matthew J. Allaway, MD.

Dr. Allaway on the increased efficiency of transperineal biopsies

PT217 is currently under investigation in the phase 1/2 SKYBRIDGE trial in patients with neuroendocrine cancers.

FDA fast tracks PT217 for neuroendocrine prostate cancer

"That pan-tumor approval and this patient case really highlight that in prostate cancer, we should be checking HER2 by immunohistochemistry," says Maneesh R. Jain, MD.

The potential of HER2 targeting in prostate cancer: A case study with trastuzumab deruxtecan

Data showed that all patients achieved a PSA decline of at least 50%. 

JANX007 demonstrates encouraging clinical activity in mCRPC

“The combination of pembrolizumab and chemotherapy presents a promising new treatment approach for these challenging-to-treat, rare cancers and could be a major breakthrough for patient care,” says Arnold I. Chin, MD, PhD.

Pembro/chemo combo shows promise in small cell/neuroendocrine bladder and prostate cancer

"Most of the published data about HIFU tended to be with relatively short-term follow-up," says Ralph J. Miller Jr, MD. 

Ralph Miller, MD, on the state of HIFU in prostate cancer

Michael Jenson, PA-C, discusses the benefits of the Surgical Impotence Management Strategy program. 

Urology PA on how the Surgical Impotence Management Strategy program results in better informed patients

 discusses the benefits of the Surgical Impotence Management Strategy program. Jenson is a physician’s assistant with Minnesota Urology.

I think that as patients go through this, it's a reminder that it's very scary. I know it's routine for the providers that are going through it, because we do it on a regular basis. Providing that that extra insight is just always going to be very helpful, and it keeps also the patients away from essentially going online, looking at blogs or social media posts, where all you're going to find is the best outcomes or the worst outcomes, [and] then you're constantly comparing where you are to those far ends of the spectrum. It's more just encouraging people to do this, to help their practice, to help their patients, and overall, it keeps them from being more frustrated patients, [and makes them] better informed patients. All that is going to benefit you and your practice.

This transcript was AI generated and edited by human editors for clarity.

Videos

The Surgical Impotence Management Strategy program aims to enhance patient care by providing comprehensive insights and support, reducing reliance on potentially misleading online information. This approach helps patients avoid comparing themselves to extreme outcomes found on social media or blogs, fostering a more informed and less frustrated patient experience. By encouraging healthcare providers to adopt this strategy, the program ultimately benefits both patients and medical practices, leading to improved patient satisfaction and outcomes.

"I think that as patients go through this, it's a reminder that it's very scary," says MIchael Jenson, PA-C.

Stacy Loeb, MD, MSc, PhD (hon), discusses the new the Sexual Concerns In Partners of Patients with Prostate cancer (SCIPPP-F) questionnaire

Expert details questionnaire for female partners of patients with prostate cancer

 discusses the new the Sexual Concerns In Partners of Patients with Prostate cancer (SCIPPP-F) questionnaire. She presented a study evaluating the SCIPPP-F, “Impact of Prostate Cancer on Sexual Quality of Life for Female Partners of Patients,” at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona. Loeb is a professor in the departments of urology and population health at NYU Grossman School of Medicine and Perlmutter Cancer Center in New York.

How does the SCIPPP-F compare to other existing measures of sexual quality of life in this population? Are there any specific domains or aspects of sexual function that the SCIPPP-F assesses that are not captured by other instruments?

Honestly, there really isn't another measure of sexual quality of life for females that addresses the specific concerns of the female partners of patients with prostate cancer, because it's more than just their own sexual function. It is all these other things that are happening too, like feeling frustration at being ignored by clinicians, feeling like they can't communicate about their feelings about their sex life with their partner, feelings of grief and loss.

But then also, there were some positive aspects too. A lot of people expressed in the survey willingness to try other methods of sexual activity to obtain sexual satisfaction, and how intimacy is so important to them above and beyond sexual intercourse, just maintaining intimacy, even things like hugging and kissing. So I do think we have a lot that we can learn from this too, in terms of ways to help people to move forward and expand the sexual repertoire to achieve satisfaction, even if it isn't in exactly the same way as it was before.

The SCIPPP-F questionnaire addresses the unique sexual quality of life concerns of female partners of prostate cancer patients, which are not covered by existing measures. It highlights issues such as frustration with clinicians, communication barriers, and feelings of grief and loss. Additionally, it reveals positive aspects, such as the willingness to explore alternative sexual activities and the importance of maintaining intimacy beyond intercourse. The findings suggest potential strategies for enhancing sexual satisfaction and intimacy for these partners, even when traditional sexual activities are altered due to the patient's condition.

"Honestly, there really isn't another measure of sexual quality of life for females that addresses the specific concerns of the female partners of patients with prostate cancer," says Stacy Loeb, MD, MSc, PhD (hon).

Andrew C. Peterson, MD, MPH, discusses implications from the study “The Artificial Urinary Sphincter Improves Depression, Anxiety and Overall Emotional Health in Men With Stress Urinary Incontinence; Analysis of the Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO),”

Andrew C. Peterson, MD, MPH, on counseling men regarding the artificial urinary sphincter

 discusses implications from the study “The Artificial Urinary Sphincter Improves Depression, Anxiety and Overall Emotional Health in Men With Stress Urinary Incontinence; Analysis of the Artificial Urinary Sphincter Clinical Outcomes Trial (AUSCO),” which he presented at the 2024 Sexual Medicine Society of North America Fall Scientific Meeting in Scottsdale, Arizona. Peterson is a professor of surgery at Duke University in Durham, North Carolina.

How can these findings be translated into clinical practice to optimize patient care and improve outcomes for men with SUI?

I think the component we as surgeons have always concentrated on is these very objective physical exam findings to relate to quality of life and to relate success of any device or surgery. For instance, any abstract or paper has to have number of pads and pad weight change in order to tell you that a device is working well for treatment of incontinence. I think that now we have good data that patient-reported outcomes have to be considered in these patient populations. We now have data that the PROs indicate significant anxiety and effects on quality of life, and the men being able to live their life normally and unencumbered and do things they want to do on a daily basis, and we've seen significant improvement with that with this study, and it's just an observational study. We've probably always seen that. The problem is, as surgeons, I don't think we've recognized that component and given it its due attention, and today is the day that I think we need to start doing this; in other words, start paying attention to how we're affecting their anxiety, their depression, their relationships with those around them, and how we're really improving those. Even though we're not going to 0 pads per day, most men are still wearing some, these other components, I think, outweigh the idea that we're not completely treating the incontinence. So an improvement, whatever it is, is really helping these men out, and I think we have to recognize that.

We use it currently in our counseling as well. Now, when I tell this story to men that we're meeting for the first time, maybe 6 months out from their surgery or radiation, or even 5 or 10 or 20 years out from their surgery or radiation, some of them look at it and say, "This is a mechanical thing. It's another surgery. I'm really not interested in surgery." When we tell them about the anxiety and the depression components, typically, we'll see the light go on in their head. Oftentimes, we'll see their family member, partner or spouse light up, as we say these types of things, and I think it can very much help them understand the other benefits they may get from undergoing treatment for male incontinence, such as the quality of life that we've been mentioning.

The study highlights the importance of considering patient-reported outcomes (PROs) in managing stress urinary incontinence (SUI) in men. While traditional metrics focus on physical improvements, the study emphasizes the significant impact of the artificial urinary sphincter on emotional health, including reductions in anxiety and depression. Surgeons are encouraged to integrate these findings into clinical practice, recognizing the broader benefits of treatment beyond physical symptoms. This approach can enhance patient counseling and decision-making, ultimately improving quality of life for men with SUI.

"I think that now we have good data that patient-reported outcomes have to be considered in these patient populations," says Andrew C. Peterson, MD, MPH. 

Michael Jenson, PA-C, offers advice for implementing a Surgical Impotence Management Strategy program. 

Expert offers advice on implementing a prostate cancer support program within a practice

 offers advice for implementing a Surgical Impotence Management Strategy program. Jenson is a physician’s assistant with Minnesota Urology.

What advice would you give health care professionals interested in implementing an initiative like the Surgical Impotence Management Strategy program?

I think it is extremely helpful. Every practice is going to be a little bit different on how they would like to approach this. Not everyone has the same resources, the same staff, that they're able to, where our group I'm a dedicated provider to a lot of the rehabilitation. I do a lot of men's health as well, but I pretty much see majority of our patients within a large half of our practice, and then the other half of the practice also has someone that does that. So having that connection to the patients, where they're going to see a familiar face that gave the lecture to them initially, that's following up with them via portal and then seeing them afterwards, that consistency is nice, but not everyone's going to have that. So it's finding what works really best for you and what you have available, and it's information. Information is always going to be beneficial. A lot of the time, you're going to have patients that go into the family tumor conference is what we call it, where they're sitting down talking about all the treatment options. They're hearing cancer surgery, radiation. They're not focusing on the other things that are mentioned by the physician, the side effects associated to each thing, what to expect shortly after. They're overwhelmed in that initial visit, so having that separate time to process that and then talk with another provider about the other stuff. Now, they've processed the cancer, they've processed what's their decision? It's kind of now focusing on a little bit of the stuff that might have been overlooked by the patient and the family.

Implementing a Surgical Impotence Management Strategy program requires tailoring the approach to the specific resources and staff available in each practice. Consistency in patient-provider interactions is beneficial, but not always feasible. Providing comprehensive information is crucial, as patients often feel overwhelmed during initial consultations. Offering separate sessions to discuss side effects and post-treatment expectations can help patients and families process information more effectively. This approach ensures that important aspects of care, which might be overlooked during initial discussions, are adequately addressed.

"Every practice is going to be a little bit different on how they would like to approach this," says Michael Jenson, PA-C.

Unmet Needs and Clinical Challenges for PSMA Imaging 

Video content above is prompted by the following:

What are some unmet needs and clinical challenges for PSMA imaging in patients with prostate cancer?

Prostate-specific membrane antigen (PSMA) imaging has significantly advanced prostate cancer diagnostics, yet several unmet needs and clinical challenges persist. These include the need for standardized imaging protocols and interpretation criteria to ensure consistent results across different clinical settings. Additionally, there is a demand for more robust data on the impact of PSMA imaging on patient outcomes, particularly in guiding treatment decisions. Furthermore, accessibility and cost-effectiveness of PSMA imaging remain concerns, as well as the need for further research into its role in various stages of prostate cancer.

Oliver Sartor, MD, discusses how unmet needs and clinical challenges for PSMA imaging in prostate cancer patients include standardizing interpretation criteria, addressing false negatives in certain tumor phenotypes, improving accessibility and cost-effectiveness, and developing strategies for patients with low PSMA expression or PSMA-negative disease.

Video Series

Unmet Needs and Clinical Challenges for PSMA Imaging

Michael Jenson, PA-C, discusses patient response to the Surgical Impotence Management Strategy program at Minnesota Urology. 

Urology PA describes patient response to prostate cancer support program

 discusses patient response to the Surgical Impotence Management Strategy program at Minnesota Urology. Jenson is a physician’s assistant with Minnesota Urology.

How has the patient response been for the Surgical Impotence Management Strategy program?

Patients, in general, have been extremely happy, and the one thing that I think keeps them happy is I'm continually evolving with how I give the information, the information that's provided, and I encourage feedback at my visits through the portal. If there's something they experience on a consistent basis that I'm hearing from a number of different providers, I typically incorporate it into the lecture, or if it's something that I did mention, but maybe I didn't spend enough time on it, and there were multiple people from a class saying, "This wasn't talked about very much," I then emphasize that a little bit greater. So I try to keep everyone as informed as possible in this. Some people are bringing up things that happen infrequently, where it's 1 in 5000. I can't touch on all of those, but it's something that I still listen to and make sure that if enough people are bringing it up, then it's something that we need to address.

Patient response to the Surgical Impotence Management Strategy program at Minnesota Urology has been overwhelmingly positive. Michael Jenson, PA-C, attributes this satisfaction to his adaptive approach in delivering information and encouraging patient feedback. He incorporates common concerns and feedback into his lectures, ensuring patients are well-informed. While he cannot address every rare issue, he remains attentive to recurring concerns. This dynamic approach helps maintain patient satisfaction and ensures the program remains responsive to patient needs and experiences.

"Patients, in general, have been extremely happy, and the one thing that I think keeps them happy is I'm continually evolving with how I give the information," says Michael Jenson, PA-C.

Bridget F. Koontz, MD, FASTRO, highlights the data supporting the ongoing phase 2 NRG-GU011 trial 

Bridget Koontz, MD, highlights trials of radiation, hormone therapy in prostate cancer

, highlights the data supporting the ongoing phase 2 NRG-GU011 trial (NCT05053152), which is assessing the combination of relugolix plus stereotactic body radiation therapy (SBRT) vs SBRT alone in patients with PET-oligometastatic prostate cancer. The trial is currently seeking enrollment.

Koontz is radiation oncologist and the medical director of radiation oncology programs at AdventHealth Cancer Institute in Orlando, Florida.

First I'd like to highlight some studies that support the rationale for our 2 treatment arms. The first is that SBRT alone arm in the PSMA recurrence [subset]. That, of course, is the ORIOLE study (NCT02680587) and STOMP study (NCT01558427). Those studies randomized to SBRT alone or observation. The fact that observation is an option for these men highlights the equipoise that we don't know that they need ADT that early in their disease course. That both showed that SBRT, particularly when it was given to all areas of known metastasis, could delay additional recurrence. The 5-year data from STOMP showed that about a third of men could go 5 years without requiring ADT, which is exciting.

The other studies from a background standpoint are 2 studies that looked at whether or not you could give intermittent hormone therapy for metastatic disease. The one of course that I think folks remember is the SWOG-9346 trial (NCT00002651), which showed that intermittent therapy was not as beneficial treatment as continuous therapy. What people forget about is the is the Canadian NCI study, the PR07 study (NCT00002633). That was also a non-inferiority study looking at PSA rise in the pre-PET M0, non-metastatic space, so the exact space that we're looking at with this study. They actually found that delaying hormone therapy or intermittent hormone therapy was non-inferior to starting immediate hormone therapy. So, that's the rationale.

There are other studies that are open right now for patients in this PSMA recurrent space. That includes the ECOG-8191 or the INDICATE trial (NCT04423211), and that's a study that actually looks at the opposite question. That looks at hormone therapy alone, plus or minus radiation. I think those 2 studies together covers the gamut of treatment options for patients. The PI of INDICATE and I wrote those studies thinking of the other trial and hoping that we'll be able to compare results. Then the last one is for VA patients, and that's called the STARPORT trial (NCT04787744), and it's looking at the same 3 treatment options as well. So, [there are] a lot of studies that are out there and available, because this is a hot space that we don't know what the right answer is. So, we can do lots of different options, but we need to do them on a study so that we can understand and learn and make sure that the next time around, we're treating patients with better evidence data.

This transcription was AI generated and edited by human editors for clarity.

The ongoing phase 2 NRG-GU011 trial is evaluating the efficacy of combining relugolix with SBRT versus SBRT alone in patients with PET-oligometastatic prostate cancer. Previous studies, such as ORIOLE and STOMP, have shown that SBRT can delay recurrence without immediate ADT. The SWOG-9346 and PR07 trials provide insights into intermittent versus continuous hormone therapy. Other ongoing trials, like ECOG-8191 and STARPORT, explore various treatment combinations, highlighting the need for evidence-based approaches in this evolving therapeutic landscape.

"The 5-year data from STOMP showed that about a third of men could go 5 years without requiring ADT, which is exciting," says Bridget F. Koontz, MD, FASTRO. 

Confirming Eligibility for Lutetium Therapy

Is this the imaging modality of choice to use to confirm eligibility for lutetium therapy? What other options are available use 68gallium PSMA-11 PET is not available?

Lutetium therapy eligibility is often confirmed using 68Gallium PSMA-11 PET imaging, which is highly effective in detecting prostate-specific membrane antigen (PSMA) expression in prostate cancer. However, if 68Gallium PSMA-11 PET is unavailable, alternative imaging modalities can be considered. These include 18F-DCFPyL PET, which also targets PSMA, and conventional imaging techniques like CT or MRI, although they may not provide the same specificity. The choice of imaging modality should be guided by availability, patient-specific factors, and the clinical context to ensure accurate assessment for lutetium therapy.

Oliver Sartor, MD, discusses how 68gallium PSMA-11 PET is indeed the preferred imaging modality for confirming eligibility for lutetium therapy, but when unavailable, alternative options such as F-18 PSMA PET, conventional bone scintigraphy, or CT/MRI may be considered, albeit with potential limitations in sensitivity and specificity.

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