Panelists discuss how regulatory approval of the radium-223 and enzalutamide combination would likely lead to significant guideline updates, particularly in treatment sequencing recommendations for patients with metastatic castration-resistant prostate cancer (mCRPC) with bone-predominant disease and adequate bone marrow function.
Experts briefly mention other ongoing phase 3 studies investigating TAR-200 for the treatment of non–muscle-invasive bladder cancer (NMIBC).
Experts discuss the patient demographics and clinical trial design of the phase 2b SunRISe-1 study investigating the use of TAR-200 as a monotherapy and in combination with cetrelimab (a PD-1 inhibitor), with results presented at the recent European Society for Medical Oncology 2024 Congress, as well as the safety and efficacy data from the SunRISe-1 trial.
Panelists discuss how adapting the PEACE-3 protocol to real-world US patient populations requires careful consideration of broader patient demographics, comorbidities, and prior treatment histories than were represented in the trial’s relatively strict eligibility criteria.
"We need to be aware that patients have options for treatment of high-risk biochemical recurrence, and in order to identify that they have high-risk biochemical recurrence...we need to calculate PSA doubling time,” says Alicia Morgans, MD, MPH.
“We might need to do a better job in general about education of the importance of follow-up,” says Christina B. Ching, MD.
"A 14-month delay in disease progression is a very meaningful end point to our patients, because that basically means delay in symptoms, delay in fractures, [and] delay in pain in the castration-resistance setting," says Neeraj Agarwal, MD, FASCO.
"I'm so excited about them finally removing this boxed warning," says Helen L. Bernie, DO, MPH.
“For someone that might be looking at getting into sacral neuromodulation, and has had some reluctance in the past, this does simplify the procedure somewhat," says Colin Goudelocke, MD.
"In terms of how I select patients, I really look at the timing of metastatic disease, so whether it's metachronous or synchronous and the volume, and I think at this stage, the data are most robust for the synchronous and high-volume patients," says Dr Louise Kostos.
“Now, at 1 year, the 1-hour pad test has been done again, as it's part of the protocol, and she suffered 4 g of incontinence on this test, opposed to 125 g at the beginning,” says Emmanuel Chartier-Kastler, MD, PhD.
"I would also like us to be able to reliably use even smaller scopes, but keep them efficient," says Amy E. Krambeck, MD.
An expert discusses how non–muscle invasive bladder cancer (NMIBC) treatment involves evolving delivery systems, transitioning from traditional systemic and intravesical approaches to advanced targeted technologies. Current research focuses on innovative platforms such as nanoparticle carriers, thermosensitive hydrogels, and personalized molecular delivery mechanisms to improve therapeutic efficacy and minimize systemic toxicity.
“Interestingly, the patients that were more likely to follow-up were those patients that were seen and established within our urology clinic,” says Christina B. Ching, MD.
"It is important for us to ask patients whether they want to intensify or not, and not make assumptions," says Alicia Morgans, MD, MPH.
"[The lack of] a battery makes it ultra small. That's really important," says Colin Goudelocke, MD.
"At 3 months, those patients had a 79% complete response rate, which was durable in 74% at 6 months and 60% at 9 months," says Jacob A. Moyer, BS.
"It was a really interesting paper to develop and write, because over the past decade, there's been such a paradigm shift in the treatment of prostate cancer," says Dr Louise Kostos.
"The primary end point was radiographic progression-free survival, which we reported in 2023, and we updated the radiographic progression-free survival data in 2025," says Neeraj Agarwal, MD, FASCO.
"[Urologists] really need to understand how big the prostate is and how big of a surgery that they're looking at," says Amy E. Krambeck, MD.
Panelists discuss how the combination of radium-223 and enzalutamide (RAD-ENZ) demonstrated a manageable safety profile in PEACE-3, with bone health monitoring and prophylactic bone-targeted therapy being crucial considerations, particularly given the potential impact on future treatment options.
Experts review different treatment delivery options available for the management of non–muscle-invasive bladder cancer (NMIBC), discuss the exciting developments in NMIBC with several delivery systems and agents under investigation, and provide information about TAR-200, a targeted release system utilizing continuous intravesical release of gemcitabine, including how TAR-200 is installed within the bladder.
Experts discuss the frequency of cystectomy use in patients with non–muscle-invasive bladder cancer (NMIBC) and how often patients are requesting bladder-sparing treatments.
Panelists discuss how the PEACE-3 trial demonstrated meaningful clinical benefits with the combination of radium-223 and enzalutamide compared with enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC), showing both improved radiologic progression-free survival and a significant overall survival advantage of 7.3 months.
Wayne Kuang, MD; and Matt T. Rosenberg, MD, discuss how overactive bladder presents with distinct pathophysiological mechanisms between genders, requires different diagnostic approaches when distinguishing from benign prostatic hyperplasia in men, impacts quality of life in older adults, benefits from early primary care intervention, and necessitates improved patient advocacy and educational initiatives for optimal management outcomes.
"The preliminary results of that study, which is a phase 1/2 dose escalation and dose expansion trial, were presented by Professor Ben Tran last year at the ENA meeting1 and showed a very favorable toxicity profile compared to erdafitinib," says Gopa Iyer, MD.
“[We’re working on] being able to apply the same mechanism and testing and thought that we put into this into stool to give people a precision signature of how they're going to respond or experience toxicity from EV based on their stool microbiome,” says Laura Bukavina, MD, MPH.
"I think we're all going to be very eager to see what happens to these patients over time," says Colin Goudelocke, MD.
"I think that 1 of the main reasons physicians weren't necessarily acting is that they weren't getting a full picture of how aggressive the disease was," says Alicia Morgans, MD, MPH.
“We felt, not only for the study, but for providing good care, that it was important to try and have these patients follow-up and see if we could identify factors that might impact their follow-up,” says Christina Ching, MD.
