Topic: Advanced Disease

New Prescribing Information on Survival Benefit for Nubeqa® (Darolutamide) Approved

E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, interviews Neal D. Shore, MD, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, about the recent FDA amendment to the package insert for NUBEQA®, or darolutamide. The amendment includes new information for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) from the ARAMIS trial on overall survival and other endpoint data, including time to pain progression and time to the requirement for cytotoxic chemotherapy. Drs. Crawford and Shore discuss how the recent data demonstrating darolutamide’s overall survival benefit validates the previous use of metastasis-free survival as a surrogate for value. They also talk about the value of darolutamide for patients with nmCRPC who may not see much benefit to taking another medication. Drs. Crawford and Shore conclude by considering darolutamide’s future, mentioning the ARASENS trial looking at darolutamide’s benefits for patients with metastatic hormone-sensitive prostate cancer and discussing potential new research into darolutamide in the mCRPC space.

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Overall Survival with Sipuleucel-T in Patients Treated for Advanced Prostate Cancer

Rana R. McKay, MD, Associate Professor of Medicine at the University of California, San Diego, and Co-Leader of the Genitourinary Oncology Disease Team at the Moores Cancer Center, discusses the results of a study that compared the efficacy of first-line and any-line sipuleucel-T to that of novel hormonal agents in Medicare beneficiaries with metastatic castration-resistant prostate cancer (mCRPC). The intent of the study was to see how the use of sipuleucel-T, which has been available for just over a decade and was the first autologous vaccine approved for a solid tumor, might be impacted by the introduction of so many new therapies for mCRPC in the last 10 years. Dr. McKay explains that the results show that, for the population studied, use of sipuleucel-T, both as first-line and any-line therapy, results in a statistically significant improvement in overall survival compared to patients who never received sipuleucel-T and were instead treated with other novel hormonal agents. Following her presentation, E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology, conducts a Q&A session with Dr. McKay in which they discuss the increasing acceptance of sipuleucel-T among medical oncologists, combination therapies with sipuleucel-T, and the future of sipuleucel-T, among other subjects.

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Clinical Case Discussion: Metastatic Prostate Cancer and Evidence for More Precision Therapy

A. Edward Yen, MD, Assistant Professor of Medicine in the Hematology and Oncology Section at Baylor College of Medicine, introduces a metastatic prostate cancer case, and through it explores and reviews treatment options. He discusses homologous recombination and the role that it plays in DNA repair pathways, noting that 25% of patients with advanced prostate cancer have deleterious mutations in DNA damage repair genes which lead to an increased risk of prostate cancer and chance of having nodal and/or distant metastases. Dr. Yen then reviews the TRITON2 study on rucaparib in mCRPC patients with homologous recombination deficiency and the PROfound study on olaparib in mCRPC patients with homologous recombination repair alterations, both of which found a far greater response to treatment in the cohorts with the target mutations. Next, Dr. Yen discusses PARP inhibitors and their side effects, such as fatigue, nausea, pulmonary embolism, anemia, and others. Through his exploration of treatment options, Dr. Yen concludes that next-line chemotherapy is the best option for the patient given the visceral progression of their disease.

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Management of mCRPC in China

Bo Dai, MD, PhD, Chief Physician and Director of the Department of Urology at Fudan University Shanghai Cancer Center, gives an overview of how metastatic castration-resistant prostate cancer (mCRPC) is managed in China. He explains that docetaxel, abiraterone, and enzalutamide are the only treatments available in China despite the proven effectiveness of other drug treatments. He references the PROfound study, which proved the effectiveness of olaparib, an FDA-approved drug which is available for metastatic ovarian cancer, but not mCRPC as of yet. Dr. Dai also reviews unmet treatment needs, including a lack of knowledge of the optimal treatment sequence, a need for overall survival improvement in the population of mCRPC patients in China, a lack of treatment urgency, and a lack of treatment affordability. He then shares data from Chinese studies on abiraterone and GT0918, which have both been found to produce positive results in patients. Dr. Dai concludes by discussing how abiraterone has become the most common mCRPC drug treatment due to it being produced in China.

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Changing Landscape of mHSPC: New Approaches to an Old Problem

Michael S. Cookson, MD, MMHC, Professor and Chairman of the Department of Urology at the University of Oklahoma Health Sciences Center in Oklahoma City, gives an overview of the changing landscape of metastatic hormone-sensitive prostate cancer (mHSPC). He reviews the different treatment strategies that have undergone testing over the last eight decades, noting that although treatment options have progressed, there is still work to be done to continue improving results. He presents the findings of key studies that look to improve survival through the use of more potent androgen-targeting techniques, among other cutting edge treatments. These new treatments show promising results in lowering risk of spread and death, bolstering Dr. Cookson’s key point: that the landscape is rapidly changing, and urologists need to adapt quickly.

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Challenging Cases in Advanced Prostate Cancer: nmCRPC

R. Jonathan Henderson, MD, a urologist with Regional Urology, LLC, discusses an unusual case of non-metastatic castration-resistant prostate cancer (nmCRPC) with a panel featuring Laurence Klotz, MD, FRCSC, Daisaku Hirano, MD, and Michael S. Cookson, MD. The case in question involves an asymptomatic patient in his 70s who was successfully treated for localized prostate cancer and then, ten years later, was treated with cryotherapy for recurrent cancer, after which point cancer stopped appearing in imaging, but the patient’s PSA rapidly rose even as he was treated with abiraterone. Drs. Klotz, Hirano, and Cookson discuss whether it is appropriate to give such treatments to a persistently asymptomatic patient and note that his high PSA could be a response to abiraterone. They also consider the possibility that advanced imaging techniques like PSMA-PET would reveal that the man does have metastases and ponder which of the approved treatments for nmCRPC might suit this patient best.

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Challenging Cases in Advanced Prostate Cancer- mHSPC

E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at University of California, San Diego, gives his expertise on next generation biomarkers in prostate cancer screening. Firstly, Dr. Crawford qualifies the new standard of PSA >1.5 ng/mL, specifically how it aids in early detection of disease and acts as a surrogate for BPH, prostate cancer, and prostatitis. Following this, Dr. Crawford reviews the clinical needs and genomic markers of prostate cancer. In conclusion, he describes his algorithm for PSA screening.

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Advanced Prostate Cancer: What’s Changing

Richard G. Harris, MD, President of LUGPA and UroPartners, discusses the recent incorporation of advanced prostate cancer (APC) clinics amongst LUGPAs within the United States. He goes on to discuss why APC clinics are important, clinical trials for m0, m1, and castrate sensitive prostate cancer, as well as the importance of genetic testing within an APC clinic.

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Retzius-Sparing Robotic-Assisted Laparoscopic Radical Prostatectomy (RARP): Rationale, Selection & Technique

Daniel C. Parker, MD, an assistant professor of urology at the University of Oklahoma, discusses the functional outcomes of the Retzius-sparing robotic-assisted laparoscopic prostatectomy (RARP) as compared to a traditional RARP. He goes on to describe the differences in postoperative continence and erectile disruption between the two approaches, how to select patients who may be candidates for a Retzius-sparing approach, as well as several randomized studies that describe any oncological and functional outcome differences between the two approaches.

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New Approaches to Metastatic Hormone Sensitive Prostate Cancer

Michael S. Cookson, MD, MMHC, Professor of Urology at the University of Oklahoma, reviews the current treatment landscape of metastatic hormone-sensitive prostate cancer (mHSPC). He goes on to discuss several aspects of the disease, including classifying patients into low or high risk, how to incorporate androgen axis inhibitors with ADT in managing newly diagnosed patients, and how to identify patients who may be candidates for chemotherapy plus ADT in patients with mHSPC.

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Expanding the Role of Surgical Management of High-Risk Prostate Cancer

Michael O. Koch, MD, the John Donohue Professor and Chair of Urology at the Indiana University School of Medicine, discusses the advantages and disadvantages of open retropubic radical prostatectomy (RRP) and robotic-assisted radical prostatectomy (RARP) in decreasing disease burden amongst high-risk prostate cancer patients. He goes on to discuss data from the Capsure Database, which placed more high-risk patients on ADT rather than surgery, as well as data from the Pivot Trial, which demonstrated a decrease in prostate cancer mortality among high-risk patients treated with surgery versus the observation (control) group. Finally, Dr. Koch evaluates several studies pertaining to the efficacy of wide surgical resection in reducing positive surgical margins among RRP and RARP cohorts, and how urologists can utilize imaging such as mpMRI and 68Ga PSMA to identify patients who would most likely benefit from wide versus nerve-sparing surgical approaches.

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Recent Clinical Radionuclide Therapy Advances in mCRPC

Ulka Vaishampayan, MD, Professor of Oncology at Wayne State University and Chief of Solid Tumor Oncology at the Karmanos Cancer Center, discusses the phase 3 randomized controlled trial of 177-Lutetium-PSMA radionuclide therapy. In this brief summary, Dr. Vaishampayan discusses the mechanism of action of this novel therapy, how to identify patients utilizing a PSMA-based PET scan, and the inclusion/exclusion criteria from the phase 3 randomized control trial of this targeted agent.

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