Benign Conditions

Benign Prostatic Hyperplasia

Bladder Cancer

Female Urology

Genitourinary Cancers

Genomic Testing

Hormone Therapy

Kidney Cancer

Challenging Anatomy

Innovative Techniques

Laser Lithotripsy

PCNL Tech & Devices

Ureteroscopy Tech & Devices

Kidney Stones

Men's Health

Next-Generation Imaging

Voiding Dysfunction

OAB and Incontinence

Pediatrics

Controveries in Urologic Cancer

Drug Therapy

Prostate Cancer

Sexual Dysfunction

UTUC

Cosmetic Surgery

Urologic Surgery

Business

Practice Management

Malpractice Consult

Health Law & Policy

Media

Case-Based Peer Perspectives

Investigator Perspectives 

Medical World News

Podcasts

Urology Medical Perspectives

UTv Videos

Peer Exchange

Special Report

Virtual Tumor Board

Insights

Medcast

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

Clinical Forums Recaps

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Treatment Landscape Evolutions

Subscribe

Articles

James C. Ulchaker, MD, shares his insights on the current range of BPH therapies.

Expert discusses the promise of emerging MISTs for BPH

Winoker is the director of endourology and director of the Center for Kidney Stone Disease at Lenox Hill and an assistant professor of urology at The Zucker School of Medicine at Hofstra/Northwell in New York, New York.

Videos

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

Jared S. Winoker, MD, addresses the wide range of stone burdens treated by the CVAC system for the study.

Study results show CVAC 2.0 is safe, efficacious for wide range of kidney stones

The application is seeking an expanded indication of talazoparib plus enzalutamide for mCRPC.  

FDA Advisory Committee unanimously votes against talazoparib plus enzalutamide for mCRPC

The committee voted 4-5 in opposition of a favorable benefit-risk profile.

FDA Advisory Committee finds evidence for UGN-102 inconclusive, cites uncertainty in benefit-risk

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times | News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Authors

"The biomarker is better at predicting presence of disease than absence, and the reason that that's important is that's how we can think about the biomarker aiding in careful clinical assessment of patients," says Elizabeth R. Plimack, MD, MS, FASCO.

Biomarker may predict MIBC status following neoadjuvant chemo

Dr. De La Cerda provides an overview of a patient case involving a 68 year-old male presenting with severe back pain, with an analysis of the clinical presentation, workup, and medical history.

Bone Predominant mCRPC Patient Case

Video content above is prompted by the following:

What are your initial impressions of the case?

Video Series

The FDA has accepted a Biologics License Application (BLA) seeking approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), or subcutaneous nivolumab, for the treatment of patients with all previously approved solid tumor indications for nivolumab as a monotherapy, monotherapy maintenance following completion of combination therapy with nivolumab plus ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib (Cabometyx).

Nivolumab is currently approved under several indications, including in combination with ipilimumab for the first-line treatment of patients with intermediate- or poor-risk advanced renal cell carcinoma (RCC), in combination with cabozantinib for the first-line treatment of patients with advanced RCC, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy, and in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024.

 According to a news release from Bristol Myers Squibb,

 approval of the formulation would make it the first and only subcutaneously administered PD-1 inhibitor.

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in the news release.

 “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in 3 to 5 minutes rather than a 30-to-60-minute infusion.”

The BLA submission is supported by findings from the phase 3 CheckMate-67T trial (NCT04810078), in which subcutaneous nivolumab met the study’s co-primary end points by demonstrating noninferiority to intravenous (IV) nivolumab regarding time average nivolumab serum concentration over 28 days (C

; geometric mean ratio [GMR}, 2.098; 90% CI, 2.001-2.200) and minimum serum concentration at a steady state (C

Data from the study, which were presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California,

 also showed that subcutaneous nivolumab demonstrated noninferiority to IV nivolumab in the key powered secondary end point of objective response rate (ORR). Specifically, the subcutaneous arm demonstrated an ORR of 24.2% (95% CI, 19.0-30.0) per blinded independent central review (BICR), compared with 18.2% (95% CI, 13.6-23.6) in the IV arm.

The safety profile for subcutaneous nivolumab was consistent with that of the IV formulation. Among patients who received the subcutaneous formulation, 8.1% experienced injection-site reactions, with all being low-grade and transient. Deaths due to study drug toxicity occurred in 3 patients in the subcutaneous arm and 1 patient in the IV arm. Most deaths that occurred during the study were due to disease progression.

In total, the phase 3, open-label CheckMate-67T trial enrolled 495 patients with advanced or metastatic ccRCC who had received prior systemic therapy. Patients were randomly assigned 1:1 to receive 1200 mg subcutaneous nivolumab plus rHuPH20 every 4 weeks (n = 248) or to 3 mg/kg IV nivolumab every 2 weeks (n = 247) for up to 2 years of treatment or until disease progression, unacceptable toxicity, withdrawal, or death.

The co-primary pharmacokinetic end points for noninferiority testing were C

 of subcutaneous nivolumab vs IV nivolumab. The key secondary end point was ORR per BICR.

Final completion of the CheckMate-67T study is expected in January 2026.

1. U.S. Food and Drug Administration accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Bristol Myers Squibb. May 6, 2024. Accessed May 7, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. Bristol Myers Squibb announces updated action date by the U.S. Food and Drug Administration for subcutaneous nivolumab (nivolumab and hyaluronidase). News release. Published online and accessed May 21, 2024. https://investors.bms.com/iframes/press-releases/press-release-details/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

3. George S, Bourlon TB, Chacon MR, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 

4. A study of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread (CheckMate-67T). ClinicalTrials.gov. Last updated March 1, 2024. Accessed May 7, 2024. https://clinicaltrials.gov/study/NCT04810078

The FDA is set to have a decision regarding the subcutaneous nivolumab formulation on or by December 29, 2024. 

News

FDA accepts BLA for subcutaneous nivolumab in solid tumors

 recently hosted a pair of roundtable discussions on upper tract urothelial carcinoma (UTUC). The programs, moderated by 

 professor in the Department of Urology at NYU Grossman School of Medicine and chief of the Urology Service at Bellevue Hospital Center in New York, New York, encompassed a range of topics related to UTUC, including clinical guidelines, treatment considerations, and patient cases.

This summary was generated by artificial intelligence and edited by humans for clarity.

At the outset, Murray set the stage by outlining the prevalence of UTUC, noting that it affects 1 to 2 individuals per 100,000 people in the United States, representing about 6% of all urothelial carcinoma cases. Symptoms such as hematuria and urinary obstruction were discussed, underscoring the necessity for regular risk stratification to inform treatment decisions, particularly as one-third of patients are diagnosed with low-grade tumors. The association between upper tract tumors and concurrent bladder cancer was also emphasized, revealing that up to 13% of patients may have concomitant bladder carcinoma.

The Importance of Tumor Grade and Location

The conversation touched upon the American Urological Association (AUA) guidelines for the treatment of UTUC, which categorize tumors as low or high risk. Factors influencing this stratification include tumor size, urinary cytology results, biopsy findings, and imaging characteristics from CT scans. The further subcategorization of low-risk and high-risk variations guides therapeutic options tailored to individual patient profiles. Participants noted that their clinical practices varied significantly, reflecting their interpretations and experiences regarding the incidence of low-grade disease. Many indicated that they see approximately 20% to 30% of patients diagnosed with isolated low-grade upper tract disease.

Murray emphasized that treatment choices for low-grade UTUC depend fundamentally on tumor grade and location. Traditionally, the gold standard treatment has been radical nephroureterectomy with bladder cuff excision; however, alternatives such as segmental ureterectomy, endoscopic treatments, antegrade or retrograde ablation techniques, and adjuvant intracavitary therapies are increasingly common. The roundtable attendees shared their perspectives on how the location of a tumor—whether in the renal pelvis or ureter—plays a crucial role in treatment decisions. The importance of individualized approaches was underscored, taking into account not only the tumor’s characteristics but also the patient's overall health and preferences.

In exploring treatment innovations, the conversation highlighted the approval of a reverse thermal gel formulation of mitomycin (Jelmyto), stemming from trial data such as the OLYMPUS trial. This product is indicated for patients with unifocal tumors less than 1.5 cm, demonstrating a 59% complete response rate for low-grade disease when applied after surgical interventions aimed at debulking the tumor. Murray posited using adjuvant therapies like this to "mop up" residual disease after extensive attempts at clearance, emphasizing the collaborative nature of modern oncology where clinical trials inform treatment practices.

Special attention was also given to the complexities of endoscopic management in upper tract disease. Although ureteroscopy is commonly performed, the inherent challenges of high recurrence rates necessitated frank discussions about the potential for stricture formation and the complications tied to nephroureterectomy, which include significant impacts on renal function and associated risks, such as surgical infections and blood transfusions.

During the roundtable, several patient cases were presented that illuminate the complexities of managing low-grade UTUC. The participants shared their clinical experiences and strategies in relation to these cases, sparking a thoughtful dialogue about treatment options and decision-making processes.

One case involved a patient with high-volume, low-grade disease. The presenting physician raised concerns about the potential for undetected high-grade tumors despite biopsy results indicating low-grade pathology. This scenario ignited conversations regarding the appropriateness of nephroureterectomy, with some participating advocating for immediate surgical intervention based on the patient's symptomatic presentation, including issues such as bleeding. The uncertainty inherent in low-grade diagnoses led to different opinions on whether to proceed with radical surgery or to adopt a more conservative, kidney-sparing approach, particularly in patients with solitary kidneys.

Another case included discussions about patients who were deemed too high-risk for nephroureterectomy. Here, the focus turned to endoscopic techniques and kidney-sparing methodologies, exploring the possibility of managing high-grade tumors endoscopically. Attendees highlighted the need for individualized discussions with patients about treatment options, weighing the chance of disease progression against the quality-of-life implications of more invasive procedures. Options such as segmental ureterectomy and emerging treatments, including intraluminal therapies, were raised as alternatives worth considering for select patients.

A notable case involved the use of adjuvant treatments for patients who demonstrated residual low-grade disease after an initial resection. The introduction of therapies like mitomycin gel was discussed, particularly for patients who would not be candidates for aggressive surgical approaches. This allowed for a more conservative management strategy, circumventing major surgeries while still aiming to manage the disease effectively.

Participants underscored the importance of follow-up strategies, particularly in cases where residual disease or multifocality raised concerns about recurrence. The consensus was that rigorous surveillance protocols, including regular ureteroscopy, were vital for ensuring ongoing tumor management. Timelines for follow-up and patient education on the likely frequency of procedures were emphasized as essential components of care.

As in the first program, Murray and the participants discussed the prevalence of UTUC, the role of the AUA guidelines, and the importance of risk stratification. A significant portion of the discussion was devoted to treatment modalities, where participants shared their approaches to managing patients with low-grade UTUC. The consensus emphasized the role of endoscopic resection, often utilized as the primary treatment for low-grade tumors. In certain cases, this may be followed by perioperative intravesical therapy with chemotherapeutics like BCG or mitomycin C. The discussion also touched on the feasibility and implications of kidney-sparing surgeries, emphasizing the need to carefully evaluate patients based on tumor characteristics and individual health factors.

One participant introduced a critical point regarding the rate of undergrading in biopsies, noting findings from a recent systematic review that indicated an undergrading rate of approximately 30%. This highlighted the inherent challenges in diagnosing UTUC accurately and how these ambiguities could affect treatment decisions significantly. The group acknowledged that this undergrading could lead to either overly conservative management or more aggressive treatment than necessary, stressing the importance of comprehensive evaluation and shared decision-making with patients.

Participants discussed their experiences with recurrent cases and tailored their treatment strategies accordingly. For instance, the discussion referenced specific patient cases where clinicians had to decide between nephroureterectomy and kidney-sparing approaches based on tumor location, grade, and patient comorbidities. They acknowledged the importance of weighing risks, such as potential surgical complications and renal insufficiency, especially in patients with solitary kidneys or chronic health issues.

During the discussion, the application and benefits of mitomycin gel in treating low-grade UTUC were central themes. The discussion highlighted that although traditional treatment often involves nephroureterectomy or intraluminal therapies, the introduction of mitomycin gel presents an additional, lower-risk option to manage low-grade cases without necessitating more invasive surgical interventions.

Participants noted that the National Comprehensive Cancer Network guidelines suggest the use of mitomycin as an adjuvant therapy following endoscopic tumor ablation. This recommendation stems from its effectiveness in achieving near or complete ablation of low-grade tumors and is supported by some clinical trial data. This gel can be administered intravesically after tumor resection, allowing for a localized treatment that minimizes systemic exposure and potentially reduces adverse events.

The conversation also addressed the risk of adverse events associated with mitomycin gel, including ureteral stenosis, which was noted to be around 29% in some patients. The participants discussed managing these risks through careful monitoring and consideration of individual patient factors when recommending this treatment option.

The methods of administering mitomycin gel were also discussed. The participants shared their experiences regarding the logistical aspects, such as whether to administer the gel using a retrograde or antegrade approach, and how these methods might differ based on institutional practices. Notably, there was a focus on the crucial role of ureteral access sheaths during the procedure, which facilitated the effective delivery of the gel while allowing for thorough tumor ablation.

As in the previous program, several patient cases were discussed, including a female patient who was a longstanding smoker and had low-grade upper tract disease treated with endoscopic resection. Post-treatment, she initially achieved a complete response while using mitomycin gel, remaining in remission for approximately 2 years.

However, upon follow-up, imaging revealed a new renal pelvic mass approximately 1 cm in size, which was subsequently confirmed to be low-grade urothelial cancer. This case exemplified the high risk of recurrence associated with endoscopic treatments, with the recurrence rate estimated at approximately 60% to 70%.

Another case involved a patient with a solitary kidney and chronic renal insufficiency, which raised considerations about potential nephron loss if nephroureterectomy were performed. The discussion highlighted the challenges of predicting future complications in the contralateral kidney, especially in patients with risk factors such as diabetes and hypertension. This case underscored the importance of individualized patient assessment, considering the overall health, risk factors, and preferences related to treatment strategies.

Upper tract urothelial carcinoma (UTUC) affects 1-2 per 100,000 people in the U.S., representing 6% of urothelial carcinoma cases. Discussions emphasized the importance of tumor grade, location, and individualized treatment strategies, including radical nephroureterectomy and emerging therapies like mitomycin gel. The challenges of accurate diagnosis, risk stratification, and managing recurrence were highlighted. Case discussions underscored the complexities of treatment decisions, particularly in patients with solitary kidneys or chronic health issues, emphasizing the need for personalized approaches and rigorous follow-up protocols.

A pair of roundtable discussions encompassed a range of topics related to UTUC, including clinical guidelines, treatment considerations, and patient cases.

Upper tract urothelial carcinoma: Key considerations and patient cases

The markets have certainly been a roller coaster lately. After a solid start to the year, the US markets have been upended by the will-they-or-won’t-they Trump administration tariffs, sticky inflation, and interest rates unlikely to drop significantly anytime soon. This volatility is not unexpected when a stock market setting new record highs suddenly experiences significant headwinds. Economic indicators also show signs of an economic slowdown. Unemployment has been creeping up, and new hires have been trending down. However, overall, the US economy continues to look fairly strong. Despite this, the stock markets have been jumping up and down from one day to another.

For investors, it is critical not to overreact. You need to block out the surrounding noise and follow your investment strategy in the face of volatile markets. Actions based on emotion and fear can cause you to make mistakes that can harm your long-term investment performance. In 2020, I wrote an article during another period of high volatility (the COVID-19 shutdown) and provided some insights for investing in these environments.

• Fight the impulse to sell your holdings if the markets are dropping. Selling after drops can make temporary losses permanent and difficult to recover. Although it can be difficult emotionally, sticking to your investment strategy may be healthier for your portfolio. It is important to continue monitoring your investments, but remember the long-term reasons the investment is in your portfolio. What role is it playing? If it is still a good fit, holding the investment may be the better long-term strategy.

• Remember that you are investing for the long term. Markets have always fluctuated up and down, and during your lifetime, you are likely to experience several significant declines. Investors should ignore the noise and stay disciplined in their designed investment strategy, which was created specifically to avoid these pitfalls.

• Review your risk tolerance. Risk you took on years ago may no longer make sense given your current circumstances and stage of life.

• Make sure your portfolio is well diversified. Volatile markets have a way of exposing improperly diversified portfolios.

• Rebalance your portfolio. Market volatility can skew your allocation from its original target. Certain assets will be more affected by market swings and will move outside their target allocations. Rebalance your portfolio by selling positions that have become overweight in relation to the rest of your portfolio and move the proceeds to positions that have become underweight.

• If you must trade during volatile markets, there are defensive steps you can take to protect your positions. Stop orders and stop-limit orders can help shield unrealized gains or limit potential losses on an existing position.

• Consider adding defensive assets such as cash and cash equivalents, Treasury securities, and other US government bonds. These can help stabilize a portfolio when stocks are slipping.

Additionally, if you are fortunate to have excess resources, there may be opportunities to take advantage of the down market. However, it is best to proceed with caution. If you determine you can invest in a volatile environment, the best approach is to do so over a period of time. It is impossible to tell when the markets have hit their bottom. Do not try to guess and invest everything in 1 lump sum. If markets continue to decline, you could lose a significant amount. It is better to break the investment into smaller increments. If you are wrong, you are not wrong with all the money you planned to invest. This strategy is called dollar-cost averaging (DCA). With a DCA strategy, it is best to select 1 day per week or 1 day per month to invest a smaller percentage of the total amount you plan to invest. Selecting a day and sticking to it will enable you to ignore the outside noise. If markets continue to decline, you are incrementally buying on the downslope and will be in a better position when markets recover.

1. Witz J. COVID-19 and market fluctuation: what you should do. 

 March 24, 2020. Accessed March 20, 2025. https://www.urologytimes.com/view/covid-19-and-market-fluctuation-what-you-should-do

8750 W. Bryn Mawr Ave. Suite 325 Chicago, Illinois 60631

312-419-3733 - Toll Free 800-883-8555 - Fax 312-332-4908 - www.mediqus.com

Investment advisory services offered through MEDIQUS Asset Advisors, Inc. Securities offered through Ausdal Financial Partners, Inc.Member FINRA/SIPC ∙ 5187 Utica Ridge Rd ∙ Davenport, IA 52807 ∙ 563-326-2064 ∙ MEDIQUS Asset Advisors and Ausdal Financial Partners, Inc. are independently owned and operated.

"If you determine you can invest in a volatile environment, the best approach is to do so over a period of time," writes Jeff Witz, CFP.

Money Matters: How to cope with market volatility in 2025

Patients who underwent nerve -sparing during robot-assisted radical prostatectomy (RARP) guided by the NeuroSAFE technique demonstrated improved erectile function at 1 year compared with patients who underwent standard RARP, according to findings from the phase 3 NeuroSAFE PROOF trial (NCT03317990).

The NeuroSAFE technique also led to improvements in urinary continence at 3 months, but this benefit was not sustained.

The data were presented at the 40th Annual European Association of Urology Congress in Madrid, Spain and published in 

“When we perform robotic radical prostatectomy, we perform a balancing act, balancing the opportunity to remove the cancer and cure it with the potential [adverse events] that come from removing important functional tissue that's closely approximated to the prostate,” explained presenting author Greg Shaw, BSc, MBBS, MD, FRCS(Urol), of the University College of London, United Kingdom. “We tend to err on the side of oncological control. Many patients who have organ-confined disease on the definitive pathology have non-nerve sparing surgery; we don't spare nerves when we could have. The NeuroSAFE procedure is an intraoperative frozen section technique. The surgeon gets feedback in real time during the operation. Having performed a nerve spare, they get to find out if that's resulted in a significant positive surgical margin, which may represent an issue with oncological control. It gives them an opportunity to regain that oncological control by performing a secondary resection.”

In total, the investigators enrolled 407 patients across 5 centers in the UK. Participants were randomly assigned 1:1 to receive NeuroSAFE RARP (n = 204) or standard RARP (n = 203). Following the procedure, 190 and 191 patients comprised the modified intent-to-treat population in each arm, respectively.

Data showed a longer operative time with the NeuroSAFE procedure vs with standard RARP. Specifically, the average surgical time was 174.4 minutes in the NeuroSAFE arm vs 131.4 minutes in the standard arm.

However, Shaw noted during the presentation, “That investment of time translated to an increase in the amount of nerve sparing that we were able to perform.”

Overall, 82.1% of patients in the NeuroSAFE arm were able to receive bilateral nerve-sparing compared with 56.4% of patients in the standard arm.

Patients in the NeuroSAFE arm also reported better erectile function at 12 months based on International Index of Erectile Function (IIEF-5) scores. Specifically, the average IIEF-5 score was 12.7 among patients in the NeuroSAFE arm vs 9.7 in the standard RARP arm (adjusted mean difference, 3.18; 95% CI, 1.62 to 4.75; 

Put another way, at 12 months following surgery, 38.7% of patients in the NeuroSAFE arm reported no or mild erectile function, compared with 22.8% of patients in the standard arm. Conversely, severe erectile function was reported in 38% of patients in the NeuroSAFE arm vs 56% of patients in the standard arm.

Measures of urinary continence at 3 months also favored the NeuroSAFE arm. The average ICIQ score was 5.8 in the NeuroSAFE arm vs 7.4 in the standard arm (adjusted mean difference, -1.41; 95% CI, -2.42 to -0.41; 

 = .006). However, this benefit was not sustained at 6 months, with an average score of 4.5 in the NeuroSAFE arm vs 5.1 in the standard RARP arm (adjusted mean difference, -0.37; 95% CI, -1.35 to 0.62; 

Oncological outcomes were similar between the 2 arms at 12 months. However, Shaw cautioned during the presentation, “We acknowledge that 12 months is a very early end point for oncological outcomes in prostate cancer. We will report on subsequent time points as our data matures.”

Specifically, prostate-specific antigen (PSA) persistence was observed in 3.8% of patients in the NeuroSAFE arm and 2.7% of patients in the standard arm. Similarly, biochemical recurrence was reported in 5.5% and 3.7% of patients, respectively.

However, the receipt of adjuvant treatment was shown to be higher in the NeuroSAFE arm (4.4% vs 1.1%). Shaw noted, “It's worth bearing in mind that this is treatment that is administered on the perception of adversity based on a pathological report. This is not driven by PSA. It's also no longer recommended practice.”

The investigators then conducted a pre-defined subgroup analysis to assess outcomes among those who would not typically have received bilateral nerve-spare. Among these patients, the average erectile function score per IIEF-5 was 12.6 in the NeuroSAFE arm (n = 120) compared with 8.7 in the standard arm (n = 114) at 12 months following surgery (mean difference, 4.4; 95% CI, 2.63 to 6.26; 

 < .001). There was no significant difference between the 2 groups in urinary continence scores at 3 months.

“Our results show that by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery,” concluded Shaw in a news release on the findings.

 “It is an involved procedure that requires expertise, but it isn’t expensive, particularly given the benefits it offers for patients, and most importantly doesn’t jeopardize cancer control. NeuroSAFE wouldn’t be appropriate for all patients, as many can safely have nerve-sparing surgery using standard robotic techniques. But for younger patients and those who wouldn’t normally be seen as eligible for nerve-sparing surgery, it offers them a greater chance to hold onto their quality of life.”

1. Almeida-Magana R, Dinneen E, Al-Hammouri T, et al. NeuroSAFE versus standard robot-assisted radical prostatectomy (NeuroSAFE PROOF): a randomised, controlled, patient-blinded, IDEAL stage 3 trial. Presented at: 40

 Annual European Association of Urology Congress. Madrid, Spain. March 21-24, 2025. Abstract GC9

2. Dinneen E, Almeida-Magana R, Al-Hammouri T, et al. Effect of NeuroSAFE-guided RARP versus standard RARP on erectile function and urinary continence in patients with localised prostate cancer (NeuroSAFE PROOF): a multicentre, patient-blinded, randomised, controlled phase 3 trial. 

. 2025. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00091-9/fulltext

3. Twice as many men recover erectile function after improved prostate cancer surgery. News release. European Association of Urology. March 24, 2025. Accessed March 27, 2025. https://www.eurekalert.org/news-releases/1077548

The NeuroSAFE technique, used during robot-assisted radical prostatectomy (RARP), enhances erectile function at one year post-surgery compared to standard RARP, as shown in the NeuroSAFE PROOF trial. While it also initially improves urinary continence at three months, this benefit diminishes by six months. The technique involves intraoperative frozen section analysis, allowing real-time feedback and potential secondary resection to maintain oncological control. Although operative time is longer, the technique increases nerve-sparing rates without compromising cancer control, offering significant quality-of-life benefits for certain patient groups.

“Our results show that by using NeuroSAFE, nearly twice as many men don’t have to face potentially life-changing loss of erectile function after prostate surgery,” says Professor Greg L. Shaw. 

NeuroSAFE procedure for RARP leads to improved erectile function

A subanalysis from the European Randomized study of Screening for Prostate Cancer (ERSPC) showed that participants who failed to attend a prostate cancer screening session despite being invited faced an increased risk of prostate cancer-specific mortality (PCSM).

Conversely, those who did attend a screening session demonstrated a 23% reduced risk of PCSM. The data were presented at the 40

 Annual European Association of Urology Congress in Madrid, Spain.

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” explained lead author, Renée Leenen MD, a PhD researcher at the Erasmus MC Cancer Institute, in a news release on the findings.

 “We need to better understand who these men are, why they choose not to attend appointments, and how to motivate them. This will help us to design population-based prostate cancer screening programs that encourage higher rates of informed participation. Tackling attendance rates in this way could be a big factor in the long-term success of a national prostate screening program.”

Overall, the ERSPC included men aged 55 to 69 years who were randomly assigned to the screening arm (n = 72,460) or to the control arm (n = 88,920). Participants were recruited across Finland, the Netherlands, Italy, Sweden, Switzerland, Belgium, and Spain. Follow-up was conducted over 20 years.

Participants in the screening arm who did not attend any of the screening rounds offered were considered non-attenders. In total, 12,401 (17%) participants in the study were non-attenders.

Data showed a rate ratio (RR) of 1.39 (95%CI 1.18-1.63) when comparing non-attenders vs the control arm and 0.77 (95%CI 0.69-0.85) when comparing attenders with the control arm. In other words, compared to the control group, non-attenders demonstrated a 39% increased risk of PCSM, while attenders demonstrated a 23% lower risk.

A subanalysis from the ERSPC revealed that men who skipped prostate cancer screening despite being invited had a higher risk of prostate cancer-specific mortality (PCSM). Attendees of the screening showed a 23% reduced risk of PCSM. The study highlighted the need to understand and motivate non-attenders, as their behavior may reflect broader care avoidance tendencies. The findings suggest that non-attendance is a significant barrier to effective population-based screening programs, emphasizing the importance of addressing awareness, informed participation, and access inequalities to improve screening outcomes.

“Our study identifies that men who were invited for screening, but do not attend screening appointments are at significantly higher risk of dying from prostate cancer compared to men who were not offered screening or accepted an invitation for screening,” says Renée Leenen MD.

Elizabeth R. Plimack, MD, MS, FASCO

Articles

Latest Updated Articles