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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

In the recent news release, Koelis reported that the final patient was enrolled in the VIOLETTE study in September 2024. 

Targeted microwave ablation shows precision, safety in localized prostate cancer

The sNDA is supported by data from the pivotal phase 3 ARANOTE trial.

FDA accepts sNDA for darolutamide plus ADT in mHSPC

“Prostate cancer patients with life expectancies of less than 5 or 10 years were being subjected to treatments that can take up to a decade to significantly improve their chances of surviving cancer, despite guidelines recommending against treatment," says Timothy J. Daskivich, MD. 

Study indicates overtreatment of men with prostate cancer and limited life expectancy

Final completion of the ECLIPSE trial is anticipated for February 2029.

ECLIPSE trial: 177Lu-PSMA-I&T extends rPFS vs hormone therapy in mCRPC

“Our study is distinguished by long follow-up, out to 12 years, looking at a broad spectrum of key complications," says Joseph M. Unger, PhD. 

Study characterizes long-term impact of prostate cancer treatment

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?

Videos

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.

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

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.

Key Trials on PARP Inhibitor Combinations in Metastatic Prostate Cancer: Efficacy and Future Considerations

Video Content above is prompted by the following:

The TALAPRO-2 study authors noted that the use of androgen receptor (AR)–targeted therapy in clinical practice has increased considerably in recent years. How might prior use of AR-targeted therapy affect the effectiveness of this combination?

What are the main safety concerns with use of talazoparib and other PARP inhibitors (eg, anemia, neutropenia, thrombocytopenia)? Would these make you more hesitant to use PARP inhibitors compared with another option?

How do you expect the results found in the TALAPRO-2 trial population to compare to that in the ZZ-First trial (NCT04332744) population (metastatic hormone-naive prostate cancer)?

What future studies are needed to clarify the optimal approaches for different populations of people with metastatic prostate cancer?

The TALAPRO-2 study highlights the increased use of androgen receptor (AR)-targeted therapy in clinical practice and examines its impact on the efficacy of combination treatments. Safety concerns with talazoparib and other PARP inhibitors, such as anemia, neutropenia, and thrombocytopenia, are discussed, raising questions about their use compared to other options. The study also considers how results might differ from the ZZ-First trial, which focuses on metastatic hormone-naive prostate cancer. Future research is needed to determine optimal treatment strategies for various metastatic prostate cancer populations.

Panelists discuss how the increased use of androgen receptor–targeted therapy in clinical practice may impact the effectiveness of PARP inhibitor combinations like talazoparib in the TALAPRO-2 study, while also addressing safety concerns, potential differences in trial populations, and the need for future studies to optimize treatment approaches for various metastatic prostate cancer patient subgroups.

Investigator Perspectives

PARP Inhibitors in Metastatic Prostate Cancer: Efficacy, Trials, and Combination Therapies

Discuss efficacy and safety findings from monotherapy trials PARP inhibitors in metastatic prostate cancer harboring homologous recombination repair gene alterations.

PARP inhibitors, particularly olaparib, have shown promise in treating metastatic prostate cancer with homologous recombination repair (HRR) gene alterations. The PROfound trial demonstrated olaparib's efficacy, significantly improving radiographic progression-free survival and overall survival compared to standard treatments. Safety profiles were consistent with known PARP inhibitor effects, with manageable adverse events. These findings underscore the potential of PARP inhibitors as a targeted therapy for patients with HRR gene alterations, offering a personalized treatment approach and highlighting the importance of genetic testing in guiding therapeutic decisions.

Panelists discuss how the PROfound trial (NCT02987543) demonstrated the efficacy and safety of olaparib monotherapy in metastatic prostate cancer patients with homologous recombination repair gene alterations, highlighting its potential as a targeted treatment option and its impact on the landscape of precision medicine in prostate cancer management.

Michael Jenson, PA-C, gives an overview of the Surgical Impotence Management Strategy program at Minnesota Urology

Michael Jenson, PA-C, on Minnesota Urology’s Surgical Impotence Management Strategy program

 gives an overview of the Surgical Impotence Management Strategy program at Minnesota Urology. Jenson is a physician’s assistant with Minnesota Urology.

What does the Surgical Impotence Management Strategy program consist of?

The program typically starts off with, they get their diagnosis, they have their conference with the physician to talk about the treatment options, and then, typically, when they have selected the treatment option, we have what's called a SIMS lecture. SIMS stands for Surgical Impotence Management Strategy. A lot of it's focused on the erections, but it's evolved significantly beyond just the erectile component of this. The lecture is provided once a month to pretty much anyone that is having surgery coming up in the next month to 2 months, trying to get people before they have surgery. Periodically, we have patients that aren't able to make it and they attend it shortly after their surgery, to get some of that information that's there. The lecture itself is going through basic information, anatomy, explaining some of the differences they may notice after surgery, why they have those differences. We dive into the post operative care, so what to expect immediately after the surgery, so while still in the hospital, or just shortly thereafter, with the catheter in place and with catheter removal, just giving further insight, because the majority of the patients haven't managed a catheter before, or really have much of an idea of what they're doing with it, or how long it's going to be in.

Then we start progressing to the side effects side of things, where we talk about incontinence and erectile dysfunction. We do touch on a number of other side effects that they will notice, especially on them. We don't go through the 1-in-5000 type options; we focus on the ones that are more common. Throughout that lecture, patients are able to ask questions, get better understanding for something that maybe was a little bit too quick, or something that was touched on by the physician that they just wanted a little bit more information on. Following that SIMS lecture, we also then have a vacuum erection device class, because we encourage a lot of our patients to pursue a vacuum erection device while going through this recovery process. And we have a class dedicated specifically to that. It's a very foreign device to a lot of people, which then creates a lot of confusion. Are they using it appropriately? How do they how do we want them to use it? I talk about it in the lecture, but it's nice to have a separate instructional class specifically dedicated to that device. So we walk them through how to properly use it. We walk them through the frequency at which we want them to use it, give them all the information that they have, and then talk about the different ones that are on the market - manual, automatic, having the combination of either/or, how to use constriction bands. It's basically everything you need to know about the vacuum erection device and our protocol that's associated with it.

Then they have their surgery. I'm there on our portal as the main resource for rehabilitation following the prostatectomy, so they can reach out to me in between, before the surgery, or shortly thereafter if they have questions. But then after the surgery, I see them. I see pretty much every one of the patients that opts into doing the SIMS protocol. And I see them typically 2 to 3 months after the surgery to just touch on, hey, what have they started? Have they started using the PDE-5 inhibitors? Have they started using the vacuum erection device? And then I follow them every 4 to 6 months. We try not to make it too often, because there isn't a lot of change that's always noted. We don't want to go too far, because we notice patients get a little bit more frustrated if it's a little bit more extended out, and they feel like they're not progressing. So we have those routine follow-ups, and then they essentially graduate from the SIMS protocol when we feel that, hey, I'm not doing much more for them, they've recovered to where we would like them.

The Surgical Impotence Management Strategy (SIMS) program at Minnesota Urology provides comprehensive pre- and post-operative education and support for patients undergoing prostatectomy. It begins with a SIMS lecture, covering anatomy, post-operative care, and common side effects like incontinence and erectile dysfunction. A separate class on vacuum erection devices is also offered. Post-surgery, patients receive ongoing support and follow-ups to monitor recovery and the use of treatments like PDE-5 inhibitors and vacuum devices. The program aims to ensure patients are well-informed and supported throughout their recovery journey.

Michael Jenson, PA-C, gives an overview of the Surgical Impotence Management Strategy program at Minnesota Urology.

Utilization of 68Gallium PSMA-11 in Clinical Practice

Discuss the availability of use 68gallium PSMA-11 gozetotide in clinical practice. What are potential strategies to increase availability?

The use of 68gallium PSMA-11 gozetotide in clinical practice is currently limited by production and distribution challenges. This radiotracer, crucial for prostate cancer imaging, faces hurdles such as the need for specialized equipment and regulatory approvals. To enhance availability, strategies could include expanding production facilities, streamlining regulatory processes, and fostering collaborations between academic institutions and industry. Additionally, investing in research to develop alternative radiotracers or more efficient production methods could alleviate supply constraints, ultimately improving access for clinicians and patients.

The panelist discusses how the limited availability of 68gallium PSMA-11 gozetotide in clinical practice poses challenges and suggests potential strategies to increase accessibility, such as expanding production facilities, improving distribution networks, and exploring alternative radiotracers with longer half-lives.

Genetic Testing in Metastatic Prostate Cancer: Key Insights on Germline and Somatic Mutations

Discuss efficacy and safety findings from monotherapy trials of PARP inhibitors in metastatic prostate cancer harboring homologous recombination repair (gene alterations. 

TALAPRO-1 trial (talazoparib), NCT03148795

Monotherapy trials of PARP inhibitors, specifically talazoparib and rucaparib, have shown promising efficacy in treating metastatic prostate cancer with homologous recombination repair gene alterations. The TALAPRO-1 trial demonstrated talazoparib's potential in improving progression-free survival and overall response rates. Similarly, the TRITON3 trial highlighted rucaparib's effectiveness in prolonging progression-free survival compared to standard treatments. Both trials underscored the importance of genetic profiling in selecting patients who would benefit most from PARP inhibitors. Safety profiles were consistent with known side effects, emphasizing the need for careful patient monitoring.

Panelists discuss how PARP inhibitor monotherapy trials like TALAPRO-1 (talazoparib) and TRITON-3 (rucaparib) have demonstrated efficacy and safety in treating metastatic prostate cancer patients with homologous recombination repair gene alterations, providing important insights into targeted therapy options for this specific patient population.

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