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Interaction of patient age and high-grade prostate cancer on targeted biopsies of MRI suspicious lesions

Pak, Jamie S; Huang, Richard; Huang, William C; Lepor, Herbert; Wysock, James S; Taneja, Samir S
OBJECTIVES/OBJECTIVE:To evaluate the interaction of patient age and Prostate Imaging-Reporting and Data System (PI-RADS) score in determining the grade of prostate cancer (PCa) identified on magnetic resonance imaging (MRI)-targeted biopsy in older men. PATIENTS AND METHODS/METHODS:From a prospectively accrued Institutional Review Board-approved comparative study of MRI-targeted and systematic biopsy between June 2012 and December 2022, men with at least one PI-RADS ≥3 lesion on pre-biopsy MRI and no prior history of PCa were selected. Ordinal and binomial logistic regression analyses were performed. RESULTS:A total of 2677 men met study criteria. The highest PI-RADS score was 3 in 1220 men (46%), 4 in 950 men (36%), and 5 in 507 men (19%). The median (interquartile range [IQR]) patient age was 66.7 (60.8-71.8) years, median (IQR) prostate-specific antigen (PSA) level was 6.1 (4.6-9.0) ng/mL, median (IQR) prostate volume was 48 (34-68) mL, and median (IQR) PSA density was 0.13 (0.08-0.20) ng/mL/mL. Clinically significant (cs)PCa and high-risk PCa were identified on targeted biopsy in 1264 (47%) and 321 (12%) men, respectively. Prevalence of csPCa and high-risk PCa were significantly higher in the older age groups. On multivariable analyses, patient age was significantly associated with csPCa but not high-risk PCa; PI-RADS score and the interaction of age and PI-RADS score were significantly associated with high-risk PCa but not csPCa. CONCLUSION/CONCLUSIONS:In our cohort, the substantial rate of high-risk PCa on MRI-ultrasound fusion targeted biopsies in older men, and its significant association with MRI findings, supports the value of pre-biopsy MRI to localise disease that could cause cancer mortality even in older men.
PMID: 38533536
ISSN: 1464-410x
CID: 5644852

High-volume prostate biopsy core involvement is not associated with an increased risk of cancer recurrence following 5-fraction stereotactic body radiation therapy monotherapy

Lischalk, Jonathan W; Sanchez, Astrid; Santos, Vianca F; Mendez, Christopher; Akerman, Meredith; Carpenter, Todd; Tam, Moses; Byun, David; Wise, David R; Mahadevan, Anand; Evans, Andrew; Huang, William; Katz, Aaron; Lepor, Herbert; Haas, Jonathan A
PURPOSE/OBJECTIVE:Percentage of positive cores involved on a systemic prostate biopsy has been established as a risk factor for adverse oncologic outcomes and is a National Comprehensive Cancer Network (NCCN) independent parameter for unfavorable intermediate-risk disease. Most data from a radiation standpoint was published in an era of conventional fractionation. We explore whether the higher biological dose delivered with SBRT can mitigate this risk factor. METHODS:A large single institutional database was interrogated to identify all patients diagnosed with localized prostate cancer (PCa) treated with 5-fraction SBRT without ADT. Pathology results were reviewed to determine detailed core involvement as well as Gleason score (GS). High-volume biopsy core involvement was defined as ≥ 50%. Weighted Gleason core involvement was reviewed, giving higher weight to higher-grade cancer. The PSA kinetics and oncologic outcomes were analyzed for association with core involvement. RESULTS:From 2009 to 2018, 1590 patients were identified who underwent SBRT for localized PCa. High-volume core involvement was a relatively rare event observed in 19% of our cohort, which was observed more in patients with small prostates (p < 0.0001) and/or intermediate-risk disease (p = 0.005). Higher PSA nadir was observed in those patients with low-volume core involvement within the intermediate-risk cohort (p = 0.004), which was confirmed when core involvement was analyzed as a continuous variable weighted by Gleason score (p = 0.049). High-volume core involvement was not associated with biochemical progression (p = 0.234). CONCLUSIONS:With a median follow-up of over 4 years, biochemical progression was not associated with pretreatment high-volume core involvement for patients treated with 5-fraction SBRT alone. In the era of prostate SBRT and MRI-directed prostate biopsies, the use of high-volume core involvement as an independent predictor of unfavorable intermediate risk disease should be revisited.
PMID: 38439040
ISSN: 1748-717x
CID: 5664372

A Randomized Clinical Trial Evaluating Indigo Carmine as a Visualization Aid for Evaluating Ureteral Patency

Lepor, Herbert; Wiegand, Lucas; Patel, Kalpesh; Du, Wei; Gagnon, Suzanne; ,
OBJECTIVES/OBJECTIVE:To determine whether intravenous indigo carmine provides a visualization advantage compared to saline in the evaluation of ureteral patency in a randomized, controlled clinical trial. METHODS:Patients undergoing urological or gynecological surgical procedures in which the patency of the ureter was to be assessed received a saline injection and were randomized to receive 2.5 mL or 5.0 mL of indigo carmine. Blinded video assessments were conducted by independent reviewers using a conspicuity scale ranked 1 (poorest) to 5 (best), and subjects with scores ≥ 3 and at least a +1-point difference from saline were considered responders. Time to visualization was recorded for indigo carmine. A responder analysis evaluated whether indigo carmine showed improved visualization. RESULTS:There were 96 ureters evaluated with the 5.0 mL dose of indigo carmine, 92 with the 2.5 mL dose, and 180 with saline. Most ureters were scored a 4 or higher on the conspicuity scale following indigo carmine; both doses were significantly better than saline (p<0.0001). Overall, 92.3% of patients were rated as a responder for either ureter. The median time to visualization of blue color was not significantly different (6.0 minutes in the 5.0 mL group and 5.9 minutes in the 2.5 mL group). There were no adverse events related to indigo carmine use. CONCLUSIONS:Both dose levels of indigo carmine were significantly better than saline as a visualization aid for ureter patency.
PMID: 38061609
ISSN: 1527-9995
CID: 5591382

Patient-reported prostate cancer treatment regret following primary partial gland cryoablation

Lepor, Herbert; Rapoport, Eli; Gogaj, Rozalba; Hernandez, Hunter; Wysock, James S
BACKGROUND:Prostate cancer treatment-related regret (TRR) incorporates the myriad effects of diagnosis and treatment with associated behavioral, emotional, and interpersonal changes within the context of patient values and expectations. We aimed to investigate TRR following primary partial gland cryoablation (PPGCA). METHODS:Men with prostate cancer undergoing PPGCA since 3/2017 enrolled in a prospective outcome registry. Between June and August 2022, a validated prostate cancer related TRR decision scale was distributed. TRR score ≥40 was considered significant TRR. Men were considered potent if they reported ability to have penetration at least half the time sexual intercourse was initiated. Associations between significant TRR and baseline characteristics and longitudinal outcomes were assessed using logistic regressions. RESULTS:Of 245 men who met inclusion criteria, 163 (67%) completed the survey with median time since cryoablation 2.3 years (IQR: 1.3, 3.6). Overall, the mean composite TRR score was 12.4/100. Significant TRR was expressed by 14% of men. Among those who were potent/had erectile function at baseline, loss of potency and erectile function were associated with higher probability of significant TRR, respectively. No associations were identified between TRR and recurrence of clinically significant prostate cancer or salvage treatment. CONCLUSIONS:The overwhelming majority of men do not express TRR following PPGCA. The loss of potency or development of erectile dysfunction predisposes to TRR. It is imperative to elucidate short-, intermediate- and long-term functional and oncological outcomes in order to define factors associated with TRR to improve counseling and reduce patient regret.
PMID: 38065805
ISSN: 1873-2496
CID: 5591622

Stereotactic Body Radiation Therapy for the Curative Treatment of Prostate Cancer in Ultralarge (≥100 cc) Glands

Hurwitz, Joshua C; Haas, Jonathan; Mendez, Christopher; Sanchez, Astrid; Santos, Vianca F; Akerman, Meredith; Carpenter, Todd; Tam, Moses; Katz, Aaron; Corcoran, Anthony; Mahadevan, Anand; Taneja, Samir S; Lepor, Herbert; Lischalk, Jonathan W
PURPOSE/OBJECTIVE:Historically, toxicity concerns have existed in patients with large prostate glands treated with radiation therapy, particularly brachytherapy. There are questions whether this risk extends to stereotactic body radiation therapy (SBRT). In this retrospective review, we examine clinical outcomes of patients with prostate glands ≥100 cc treated curatively with SBRT. METHODS AND MATERIALS/METHODS:We retrospectively analyzed a large institutional database to identify patients with histologically confirmed localized prostate cancer in glands ≥100 cc, who were treated with definitive-robotic SBRT. Prostate volume (PV) was determined by treatment planning magnetic resonance imaging. Toxicity was measured using Common Terminology Criteria for Adverse Events, version 5.0. Many patients received the Expanded Prostate Cancer Index Composite Quality of Life questionnaires. Minimum follow-up (FU) was 2 years. RESULTS:Seventy-one patients were identified with PV ≥100 cc. Most had grade group (GG) 1 or 2 (41% and 37%, respectively) disease. All patients received a total dose of 3500 to 3625 cGy in 5 fractions. A minority (27%) received androgen deprivation therapy (ADT), which was used for gland size downsizing in only 10% of cases. Nearly half (45%) were taking GU medications for urinary dysfunction before RT. Median toxicity FU was 4.0 years. Two-year rates of grade 1+ genitourinary (GU), grade 1+ gastrointestinal (GI), and grade 2+ GU toxicity were 43.5%, 15.9%, and 30.4%, respectively. Total grade 3 GU toxicities were very limited (2.8%). There were no grade 3 GI toxicities. On logistic regression analysis, pretreatment use of GU medications was significantly associated with increased rate of grade 2+ GU toxicity (odds ratio, 3.19; P = .024). Furthermore, PV (analyzed as a continuous variable) did not have an effect on toxicity, quality of life, or oncologic outcomes. CONCLUSIONS:With early FU, ultra large prostate glands do not portend increased risk of high-grade toxicity after SBRT but likely carry an elevated risk of low-grade GU toxicity.
PMID: 37984713
ISSN: 1879-8519
CID: 5608362

Primary Whole-gland Ablation for the Treatment of Clinically Localized Prostate Cancer: A Focal Therapy Society Best Practice Statement

Deivasigamani, Sriram; Kotamarti, Srinath; Rastinehad, Ardeshir R; Salas, Rafael Sanchez; de la Rosette, J J M C H; Lepor, Herbert; Pinto, Peter; Ahmed, Hashim U; Gill, Inderbir; Klotz, Laurence; Taneja, Samir S; Emberton, Mark; Lawrentschuk, Nathan; Wysock, James; Feller, John F; Crouzet, Sebastien; Kumar M, Praveen; Seguier, Denis; Adams, Eric S; Michael, Zoe; Abreu, Andre; Jack Tay, Kae; Ward, John F; Shinohara, Katsuto; Katz, Aaron E; Villers, Arnauld; Chin, Joseph L; Stricker, Phillip D; Baco, Eduard; Macek, Petr; Ahmad, Ardalan E; Chiu, Peter K F; Crawford, E David; Rogers, Craig G; Futterer, Jurgen J; Rais-Bahrami, Soroush; Robertson, Cary N; Hadaschik, Boris; Marra, Giancarlo; Valerio, Massimo; Chong, Kian Tai; Kasivisvanathan, Veeru; Tan, Wei Phin; Lomas, Derek; Walz, Jochen; Guimaraes, Gustavo Cardoso; Mertziotis, Nikos I; Becher, Ezequiel; Finelli, Antonio; Kasraeian, Ali; Lebastchi, Amir H; Vora, Anup; Rosen, Mark A; Bakir, Baris; Arcot, Rohit; Yee, Samuel; Netsch, Christopher; Meng, Xiaosong; de Reijke, Theo M; Tan, Yu Guang; Regusci, Stefano; Benjamin, Tavya G R; Olivares, Ruben; Noureldin, Mohamed; Bianco, Fernando J; Sivaraman, Arjun; Kim, Fernando J; Given, Robert W; Dason, Shawn; Sheetz, Tyler J; Shoji, Sunao; Schulman, Ariel; Royce, Peter; Shah, Taimur T; Scionti, Stephen; Salomon, Georg; Laguna, Pilar; Tourinho-Barbosa, Rafael; Aminsharifi, Alireza; Cathelineau, Xavier; Gontero, Paolo; Stabile, Armando; Grummet, Jeremy; Ledbetter, Leila; Graton, Margaret; Stephen Jones, J; Polascik, Thomas J
CONTEXT/BACKGROUND:Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. OBJECTIVE:To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. EVIDENCE ACQUISITION/METHODS:We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. EVIDENCE SYNTHESIS/RESULTS:Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence-free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71-79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4-98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. CONCLUSIONS:The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. PATIENT SUMMARY/RESULTS:Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.
PMID: 37419773
ISSN: 1873-7560
CID: 5539512

Legends in Urology V30I06

Lepor, Herbert
PMID: 38104327
ISSN: 1195-9479
CID: 5612542

Reply by Authors [Comment]

Wysock, James S; Rapoport, Eli; Hernandez, Hunter; Gogaj, Rozalba; Lepor, Herbert
PMID: 37555599
ISSN: 1527-3792
CID: 5619072

Biopsy Assessment of Oncologic Control 3 Years Following Primary Partial Gland Cryoablation: A Prospective Cohort Study of Men With Intermediate-risk Prostate Cancer

Wysock, James S; Rapoport, Eli; Hernandez, Hunter; Gogaj, Rozalba; Lepor, Herbert
PURPOSE:We evaluated 3-year oncologic outcomes following primary partial gland cryoablation. MATERIALS AND METHODS:Men with unilateral intermediate-risk prostate cancer undergoing primary partial gland cryoablation since March 2017 enrolled in a prospective outcome registry. The postablation protocol for all men included surveillance prostate biopsy at 2 years postablation and reflex prostate biopsy for cases with high suspicion of recurrence (eg, progressive rise in PSA). Recurrence of clinically significant prostate cancer was defined as any Gleason grade group ≥2 disease on postablation biopsy. Freedom from failure represented no whole gland salvage treatment, metastatic prostate cancer, or prostate cancer mortality. Freedom from recurrence and freedom from failure were characterized using nonparametric maximum likelihood estimators. RESULTS:A total of 132 men had at least 24 months of follow-up data. Biopsies identified clinically significant prostate cancer in 12 men. At 36 months, model-estimated rates of freedom from recurrence of in-field, out-of-field, and overall clinically significant cancer were 97% (95% CI: 92-100), 87% (95% CI: 80-94), and 86% (95% CI: 78-93), respectively. The model-estimated proportion with freedom from failure at 36 months was 97% (95% CI: 93-100). CONCLUSIONS:The low in-field cancer detection rate at 3 years indicates successful ablation of localized cancers. Conversely, our observed out-of-field detection rate highlights the need for continued surveillance following partial gland cryoablation. Many of these recurrences exhibited very low volume of clinically significant disease below the detection threshold of multiparametric MRI, suggesting a limited role for multiparametric MRI in detecting clinically significant recurrences at 2 years. These findings emphasize the need for long-term surveillance and identification of predictors of clinically significant prostate cancer recurrences to guide biopsy timing.
PMID: 37285232
ISSN: 1527-3792
CID: 5594592

Salvage Cryoablation and Robotic Seminal Vesiculectomy: A Novel Salvage Treatment for Locally Recurrent Prostate Cancer

Smigelski, Michael B; Wysock, James; Taneja, Samir S; Lepor, Herbert
PMID: 37300480
ISSN: 1557-900x
CID: 5594642