Favorable Intermediate-risk Prostate Cancer Research Articles

Racial and Ethnic Variation in Receipt and Intensity of Active Surveillance for Older Patients With Localized Prostate Cancer.

The use of active surveillance (AS) for prostate cancer is increasing, and racial disparities have been identified in its implementation. We investigated differences by race and ethnicity in the utilization and intensity of AS by race and ethnicity among older men with low- and favorable intermediate-risk prostate cancer, with particular focus on the integration of multiparametric MRI (mpMRI) into AS protocols. Using the Surveillance, Epidemiology, and End Results and Medicare fee-for-service linked database, we identified a cohort of men diagnosed between 2010 and 2017 with low- or favorable intermediate-risk prostate cancer. The odds of receiving AS were compared by patient race and ethnicity using multivariable logistic regression models, while the rates of usage of PSA tests, biopsy, and mpMRI within 2 years of diagnosis among men on AS were assessed using multivariable Poisson regression models. Our cohort included 33,542 men. The proportion of men with low-risk disease who underwent AS increased from 29.5% in 2010 to 51.7% in 2017, while the proportion among men with favorable intermediate disease grew from 11.4% to 17.2%. Hispanic (odds ratio [OR] = 0.68, 95% CI 0.58-0.79) and non-Hispanic Black men (OR = 0.78, 95% CI 0.68-0.89) were less likely to receive AS than non-Hispanic White men for low-risk disease, while non-Hispanic Black men were more likely to receive AS for favorable intermediate disease (OR = 1.21, 95% CI 1.04-1.39). Non-Hispanic Black men receiving AS underwent prostate MRI at a lower rate compared to non-Hispanic White men, regardless of whether they had low-risk (incidence rate ratio = 0.77, 95% CI 0.61-0.97) or favorable intermediate-risk (incidence rate ratio = 0.61, 95% CI 0.44-0.83) disease, respectively. The overall adoption of AS for low-risk prostate cancer increased among Medicare fee-for-service beneficiaries. However, a significant disparity exists for non-Hispanic Black men, as they exhibit lower rates of AS utilization. Moreover, non-Hispanic Black men are less likely to have access to novel technologies, such as mpMRI, as part of their AS protocols.

Impact of Family History and Germline Genetic Risk Single Nucleotide Polymorphisms on Long-Term Outcomes of Favorable-Risk Prostate Cancer.

Family history and germline genetic risk single nucleotide polymorphisms (SNPs) have been separately shown to stratify lifetime risk of prostate cancer. Here, we evaluate the combined prognostic value of family history of prostate and other related cancers and germline risk SNPs among patients with favorable-risk prostate cancer. A total of 1367 participants from the prospective Health Professionals Follow-up Study diagnosed with low- or favorable intermediate-risk prostate cancer from 1986 to 2017 underwent genome-wide SNP genotyping. Multivariable Cox regression was used to estimate the association between family history, specific germline risk variants, and a 269 SNP polygenic risk score with prostate cancer‒specific death. Family history of prostate, breast, and/or pancreatic cancer was observed in 489 (36%) participants. With median follow-up from diagnosis of 14.9 years, participants with favorable-risk prostate cancer with a positive family history had a significantly higher risk of prostate cancer‒specific death (HR 1.95, 95% CI 1.15-3.32, P = .014) compared to those without any family history. The rs2735839 (19q13) risk allele was associated with prostate cancer‒specific death (HR 1.81 per risk allele, 95% CI 1.04-3.17, P = .037), whereas the polygenic risk score was not. Combined family history and rs2735839 risk allele were each associated with an additive risk of prostate cancer‒specific death (HR 1.78 per risk factor, 95% CI 1.25-2.53, P = .001). Family history of prostate, breast, or pancreatic cancer and/or a 19q13 germline risk allele are associated with an elevated risk of prostate cancer‒specific death among favorable-risk patients. These findings have implications for how family history and germline genetic risk SNPs should be factored into clinical decision-making around favorable-risk prostate cancer.

Delaying Surgery in Favorable-Risk Prostate Cancer Patients: An NCDB Analysis of Oncologic Outcomes

IntroductionConcern for overtreatment in very low-, low-, and favorable intermediate-risk prostate cancer has promoted a more conservative approach through active surveillance (AS) with comparable survival outcomes. We analyzed the National Cancer Database (NCDB) to determine if delaying radical prostatectomy greater than 6 months is associated with an increase in the rate of adverse pathology or secondary treatment (adjuvant or salvage) at radical prostatectomy. MethodsUtilizing the NCDB from 2004 to 2019, 40 to 75-year-old men with very low-, low-, and favorable-intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network, were identified for this study. These individuals received radical prostatectomy either before or after 6 months following diagnosis. Clinical, demographic, and pathologic characteristics were obtained. Adverse pathologic outcomes were defined as pT3-4N0-1 and/or positive surgical margins. Multiple logistic regression models were used to predict delays in treatment, adverse pathologic outcomes, and receipt of secondary therapy. Survival analysis was performed using the Cox Proportional Hazards Model and the Kaplan-Meier Method. ResultsOf the 195,397 patients who met inclusion criteria, only 13,393 patients received surgery 6 months after diagnosis. The median time of delay was 7.5 months compared to 2.3 months in the immediate treatment group. Overall, delaying surgery had no statistically significant impact on adverse pathologic outcomes, regardless of risk category. However, when accounting for the interaction between race and delayed treatment, non-Hispanic black patients who received a delay in treatment were more likely to experience adverse features (OR 1.12, 95%CI 1.00-1.26, P = .041). Conversely, patients who had delayed surgery were less likely to receive additional therapy (either adjuvant or salvage) (OR 0.60, 95%CI 0.52-0.68, P < .001). Survival analysis showed that both groups fared well, with a 5-year survival of 97% for both groups. The treatment group was not predictive of survival. ConclusionOverall, delaying surgery more than 6 months following diagnosis did not have a significant impact on adverse pathologic features or overall survival. However, when specifically looking at non-Hispanic black patients with a treatment delay, these patients were at increased risk for adverse features, suggesting that the negative impact of treatment delay depends on the patient's race. As race is a social construct, this finding likely points to the complex socioeconomic factors that contribute to overall health outcomes rather than any inherent disease characteristics. Lastly, delayed treatment patients were actually less likely to require secondary therapy, regardless of race, possibly reflecting high clinician acumen in selecting patients appropriate for treatment delay. The results suggest that patients who ultimately “fail” AS and require subsequent surgery have overall comparable survival outcomes. However, pathologic outcomes are dependent on the patient's underlying race, with non-Hispanic black patients experiencing an increased risk of adverse outcomes if treatment is delayed.

SABR-Dual: a phase II/III trial of two-fraction versus five-fraction stereotactic radiotherapy for localized low- and favorable intermediate-risk prostate cancer.

Dose-escalated radiotherapy is known to improve progression free survival in patients with localized prostate cancer, and recent advances have led to the standardization of ultrahypofractionated stereotactic ablative radiotherapy (SABR) delivered in just 5-fractions. Based on the known effectiveness of the accepted though invasive 2-fraction treatment method of high-dose-rate brachytherapy and given the ubiquity of prostate cancer, a further reduction in the number of treatments of external-beam SABR is possible. This study aims to evaluate the safety, efficacy, and non-inferiority of generalizable 2-fraction SABR compared to the current 5-fraction regimen. 502 patients will be enrolled on this phase II/III randomized control trial. Eligible patients will have previously untreated low- or favorable intermediate-risk adenocarcinoma of the prostate. Patients will be randomized between standard SABR of 40Gy in 5 fractions given every-other-day and 27Gy in 2 fractions at least two days apart but completing within seven days. MRI-based planning, radiopaque hydrogel spacer insertion, and fiducial marker placement are required, and SABR will be delivered on either a standard CT-guided linear accelerator or MR-LINAC. The primary endpoint will be freedom from disease progression, with additional secondary clinical, toxicity, and quality of life endpoints. This study will be the largest prospective randomized trial, adequately powered to demonstrate non-inferiority, comparing 2-fraction SABR to standard 5-fraction SABR for localized prostate cancer. As the protocol does not obligate use of an MRI-LINAC or other adaptive technologies, results will be broadly generalizable to the wider community. This trial is registered on Clinicaltrials.gov: ClinicalTrials.gov Identifier: NCT06027892.

Tumor upgrading among very favorable intermediate-risk prostate cancer patients treated with robot-assisted radical prostatectomy: how can it impact the clinical course?

We sought to investigate predictors of unfavorable tumor upgrading in very favorable intermediate-risk (IR) prostate cancer (PCa) patients treated with robot-assisted radical prostatectomy, in addition to evaluate how it may affect the risk of disease progression. A very favorable subset of IR PCa patients presenting with prostate-specific antigen (PSA) < 10ng/mL, percentage of biopsy positive cores (BPC) < 50%, and either International Society of Urological Pathology (ISUP) grade group 1 and clinical stage T2b or ISUP grade group 2 and clinical stage T1c-2b was identified. Unfavorable pathology at radical prostatectomy was defined as the presence of ISUP grade group > 2 (unfavorable tumor upgrading), extracapsular extension (ECE), and seminal vesicle invasion (SVI). Disease progression was defined as the event of biochemical recurrence and/or local recurrence and/or distant metastases. Associations were evaluated by Cox regression and logistic regression analyses. Overall, 210 patients were identified between January 2013 and October 2020. Unfavorable tumor upgrading was detected in 71 (33.8%) cases, and adverse tumor stage, including ECE or SVI in 18 (8.6%) and 11 (5.2%) patients, respectively. Median (interquartile range) follow-up was 38.5 (16-61) months. PCa progression occurred in 24 (11.4%) patients. Very favorable IR PCa patients with unfavorable tumor upgrading at final pathology showed a persistent risk of disease progression, which hold significance after adjustment for all factors (Hazard Ratio [HR]: 5.95, 95% Confidence Interval [CI]: 1.97-17.92, p = 0.002) of which PSA was an independent predictor (HR: 1.52, 95% CI 1.12-2.08, p = 0.008). Moreover, these subjects were more likely to belong to the biopsy ISUP grade group 2. Very favorable IR PCa patients hiding unfavorable tumor upgrading were more likely to experience disease progression. Unfavorable tumor upgrading involved about one-third of cases and was less likely to occur in patients presenting with biopsy ISUP grade group 1. Tumor misclassification is an issue to discuss, when counseling this subset of patients for active surveillance because of the risk of delayed active treatment.

Radiotherapy in localized prostate cancer: amulticenter analysis evaluating tumor control and late toxicity after brachytherapy and external beam radiotherapy in 1293 patients.

Comparing oncological outcomes and toxicity after primary treatment of localized prostate cancer using HDR- or LDR-mono-brachytherapy (BT), or conventionally (CF) or moderately hypofractionated (HF) external beam radiotherapy. Retrospectively, patients with low- (LR) or favorable intermediate-risk (IR) prostate cancer treated between 03/2000 and 09/2022 in two centers were included. Treatment was performed using either CF with total doses between 74and 78 Gy, HF with 2.4-2.6 Gy per fraction in 30fractions, or LDR- or HDR-BT. Biochemical control (BC) according to the Phoenix criteria, and late gastrointestinal (GI), and genitourinary (GU) toxicity according to RTOG/EORTC criteria were assessed. We identified 1293 patients, 697 with LR and 596 with IR prostate cancer. Of these, 470, 182, 480, and 161 were treated with CF, HF, LDR-BT, and HDR-BT, respectively. For BC, we did not find asignificant difference between treatments in LR and IR (p = 0.31 and 0.72). The 5‑year BC for LR was between 93and 95% for all treatment types. For IR, BC was between 88% in the CF and 94% in the HF group. For CF and HF, maximum GI and GU toxicity grade ≥ 2 was between 22and 27%. For LDR-BT, we observed 67% grade ≥ 2 GU toxicity. Maximum GI grade ≥ 2 toxicity was 9%. For HDR-BT, we observed 1% GI grade ≥ 2 toxicity and 19% GU grade ≥ 2 toxicity. All types of therapy were effective and well received. HDR-BT caused the least late toxicities, especially GI.

Brachytherapy for favorable prognostic prostate cancer in men up to 60 years of age: Long term follow-up

Brachytherapy (BT) is a standard treatment for low- and favorable intermediate-risk prostate adenocarcinoma. Few studies have focused on young patients. We therefore evaluated long-term efficacy and toxicity of BT in patients aged ≤ 60 years with low- and favorable intermediate-risk prostate cancer. This retrospective study included patients aged ≤60 years with low- or favorable intermediate-risk prostate adenocarcinoma treated with iodine BT alone between 1999 and 2014 at the Institut de Cancérologie de Lorraine. Follow-up assessment included incidence of biochemical failure (BF) at 10 and 15 years after BT, as well as survival data and late toxicities. A total of 177 patients of median age 56 years (54-58) were analyzed, with a median follow-up of 126 months (97-172). Incidence of BF at 10 and 15 years after BT was 5.4% and 11.7% respectively. PSA nadir (HR = 51.8 [95% CI 6.69-277], p < 0.001), age at treatment (HR = 1.78 [95% CI 1.19-2.65], p = 0.005) and prostate D90% (HR = 1.08 [95% CI 1.01-1.15], p < 0.021) were identified as predictive factors of BF. Overall survival at 10 and 15 years after BT was 92.8% and 84.4% respectively. Cancer-specific survival at 10 and 15 years after BT was 99.3% and 97.7% respectively. No major toxicity was recorded. Exclusive BT is a long-term effective treatment for patients aged ≤ 60 years with low- or favorable intermediate-risk prostate adenocarcinoma.

Predictors of PSMA positivity at initial staging of prostate cancer.

283 Background: PSMA-based imaging improves detection of metastatic disease for initial staging of men diagnosed with prostate cancer (PCa) with higher accuracy compared to conventional imaging. PSMA imaging is now being increasingly adopted for initial local and distant metastatic staging. We sought to determine the contribution of clinical and pathological factors associated with PSMA positive nodal or metastatic disease. Methods: We retrospectively identified 404 men diagnosed with PCa who underwent initial staging with Gallium-68 or F-18 piflufolastat (DCFPyL) PSMA PET/CT across our eleven-hospital system from July 2021-December 2022. Patient characteristics, including demographic, clinical, pathologic, and imaging variables were obtained. PSMA positivity representing a suspicious nodal or distant lesion was determined based on radiology reports, histopathology, and other imaging modalities, and equivocal or likely benign lesions were counted as negative. Patients with prior diagnosis (&gt;6 months) of PCa (n=42) or incomplete clinical history (n=22) were excluded. Clinical variables were compared with Wilcoxon Rank Test, Chi square, and Fishers’ exact test as well as univariable and multivariable logistic regression. Number of risk factors for patients with unfavorable intermediate or very high risk disease was also examined. PSA was log transformed. Statistical significance was defined as p&lt;0.05. Results: 103/340 patients (30.3%) had PSMA imaging findings concerning for nodal or distant metastatic disease. Patients with positive finding were less likely to be Black, and had higher PSA, biopsy Gleason Grade Group, and higher presumptive NCCN risk. Stratifying by pre-scan NCCN risk group, PSMA positivity was observed in no patients with favorable intermediate risk PCa (n=17), 9.8% (12/123) with unfavorable intermediate risk PCa, 29% (25/86) with high risk PCa, and 58% (66/114) with very high risk PCa. Stratifying by number of risk factors, there were significant differences in scan positivity comparing unfavorable intermediate risk disease with 1 vs ≥2 risk factors (4.2% vs 17%, p=0.03) and very high risk disease with 1 risk vs ≥2 risk factors (49% vs 72%, p=0.01). On multivariable analysis, NCCN classification stratified by risk factors was associated with PSMA positivity while Black race was inversely associated (OR 0.32, 95% CI 0.11, 0.82, p=0.03). Conclusions: Initial staging with PSMA PET/CT identified local regional or metastatic disease in 30% of PCa patients. A substantial proportion of unfavorable intermediate risk men were N1 or M1 based on PSMA positivity, particularly those with multiple unfavorable intermediate risk features. The clinical benefit for PSMA PET/CT in patients with favorable intermediate risk PCa is low. Limitations include retrospective design (including possible selection bias for patients with equivocal lesions on conventional imaging) and a limited number of black men in the cohort.

Oncological Outcomes in Men With Favorable Intermediate Risk Prostate Cancer Enrolled in Active Surveillance.

To evaluate the long-term oncological outcomes in men with intermediate risk prostate cancer (PCa) enrolled in active surveillance (AS). From April 2015 to December 2022, 30 men with Gleason score 3+4/ISUP Grade Group2 (GG2), greatest percentage of cancer (GPC) ≤50%, Gleason pattern 4 ≤10%, ≤3 positive biopsy cores were enrolled in AS. All patients underwent confirmatory transperineal saturation biopsy (SPBx: 20 cores) 12 months from diagnosis plus multiparametric magnetic resonance (mpMRI) evaluation. At the last follow-up, 68Ga prostate-specific membrane antigen (PSMA) positron-emission tomography (PET)/computed tomography (CT) was added: lesions with PIRADS score ≥3 and/or standardized uptake value (SUVmax) >5 were submitted to four targeted cores. Three out of 30 (10%) men with GG2 PCa were reclassified at confirmatory biopsy. At the last follow-up (median 5.2 years), only 2 of 27 (7.4%) men were reclassified and 23/30 (76.6%) continued AS. Men with favorable GG2 PCa enrolled in AS have good long-term oncological results. The use of selective criteria (i.e., SPBx, mpMRI, PSMA PET/CT) reduces the risk of reclassification.

A Phase I/II Dose-Escalation Study Evaluating the Safety of 21 Gy, 23 Gy, and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy: An Interim Toxicity Report.

Single-fraction high dose rate (HDR) prostate brachytherapy has shown improved actuarial biochemical control rates from 66% to 82% with dose escalation from 19 to 20.5 Gy, respectively, but is still inferior to the reported low dose rate brachytherapy control rates of over 90%. We aimed to identify whether dose escalation to 21, 23, and 25 Gy can be safely accomplished. Patients with previously untreated, pathologically confirmed, low-risk (cT1-T2a, Gleason ≤6, PSA <10 ng/mL) or favorable intermediate risk (Gleason 3+4, percentage of positive biopsy cores <50%, ≤1 NCCN intermediate risk factor) prostate adenocarcinoma were enrolled from a single institution. PSA and toxicity assessment were performed at baseline and at routine 6-month follow-ups. From May 9, 2018 to May 12, 2022, 18 patients were enrolled. None had received prior androgen deprivation therapy, 44% had low risk disease, and 61% were ECOG 0 at baseline. Median age was 68 years (total range: 43-79), and 83% were Caucasian. Eight patients received 21 Gy, nine patients received 23 Gy, and one patient received 25 Gy, with the 25 Gy cohort still accruing. The mean prostate size and range, determined by pre-operative prostate volume study on trans-rectal ultrasound, were as follows: 21Gy cohort (mean: 41.2cc; range: 21.9-63.1cc), 23Gy Cohort (mean: 41.2cc, range 28.3-71.7cc), 25Gy cohort (65.3cc). A median of 17 catheters (range: 16-20) were implanted. At a median follow-up of 35.7 months (range: IQR 4.4 - 50.2), only one grade 3 toxicity was reported, which was an ulcerative colitis (UC) flare noted in a patient whose UC was poorly controlled, requiring multiple courses of prednisone in the 6 months prior to his brachytherapy. Regarding toxicities attributable to therapy, fourteen and four patients experienced a grade 1 and 2 genitourinary toxicity respectively; four and four patients experienced a grade 1 and 2 reproductive system toxicity respectively; one patient experienced a grade 1 GI toxicity. Two patients needed foley catheters upon discharge, with neither requiring the foley long term. There were two treatment failures in the 21Gy cohort at 1.39 and 1.67 years from date of HDR brachytherapy; date of failure was defined by the first PSA 2.0ng/mL over nadir. Of these patients, one underwent focal salvage HDR, whilst the other underwent radical prostatectomy with only 1% of the volume involved by prostate cancer. Of note, there was seminal vesicle involvement on restaging prostate biopsy for the patient that underwent radical prostatectomy, however, this was not appreciated on the final prostatectomy specimen. Both patients have no evidence of disease currently. HDR brachytherapy appears well tolerated in patients with low to favorable intermediate risk prostate cancer at 21 and 23 Gy, with more accrual needed at 25Gy. Long-term follow-up needed to assess efficacy.

Active surveillance in favorable intermediate-risk prostate cancer: A single-center experience

PurposeTo report the long-term oncological outcomes of active surveillance (AS) in selected patients with favorable intermediate-risk (IR) prostate cancer (PCa). MethodsA retrospective database review of two academic centers was conducted to identify favorable IR PCa patients initially managed by AS between 2014 and 2022. Favorable IR PCa was defined by the presence of one single element of IR disease (i.e., PSA 10–20ng/mL, Gleason Grade Group [GG] 2, or cT2b). All patients were diagnosed and followed up according to a contemporary scheme, including MRI and image-guided biopsies. The primary endpoint was metastasis-free survival. ResultsA total of 57 patients met our inclusion criteria and the median follow-up was 56months. During follow-up, there were no cases of metastasis or death due to PCa, but 6 deaths due to competing causes. A total of 25 (44%) and 6 patients (11%) had definitive treatment and GG 3 reclassification during follow-up, respectively. In multivariable Cox hazard regression analysis, the risk of undergoing definitive treatment was significantly associated with PSA density>0.15 (HR: 4.82, 95% CI: 1.47 to 15; P=0.01) and PI-RADS 4-5 lesions on mpMRI (HR: 2.48, 95% CI: 1.06 to 5.19; P=0.006). Interestingly, tumor burden (P=0.3) and GG (P=0.7) on biopsy were not associated with definitive treatment. ConclusionsAS is a safe and valuable strategy for well-selected patients with favorable IR prostate cancer, with excellent oncological outcomes after five years’ follow-up. Level of evidence4

Increasing Use of Conservative Management of Low-Risk Prostate Cancer in the Veterans Affairs System from 2012 to 2021

Conservative management (CM), including either active surveillance or watchful waiting, is the preferred management strategy for men with low-risk prostate cancer. We sought to describe contemporary trends in CM among men with localized prostate cancer across the equal-access Veterans Affairs (VA) system. Using VA tumor registry data, we identified all men with a new diagnosis of biopsy-proven, clinically node-negative, non-metastatic prostatic adenocarcinoma from 2012 to 2021, excluding men with missing National Comprehensive Cancer Network risk group. We quantified the yearly proportion of patients with low and favorable intermediate-risk (FIR) prostate cancer undergoing conservative management and examined age-specific rates. Multivariable logistic regression was used to identify independent clinical predictors of CM among men with low-risk and FIR disease. The cohort included 86,415 patients with localized prostate cancer, of whom 20,290 (23.5%) had low risk and 25,447 (29.5%) had FIR disease. The proportion of men diagnosed with low-risk disease decreased from 27.7% in 2012 to 20.1% in 2021. The proportion of men with localized prostate cancer who were 70 years or older at diagnosis increased from 19.5% in 2012 to 46.4% in 2021, with similar increases seen across risk groups. The proportion of men with low-risk disease undergoing CM increased from 63.1% in 2012 to 86.6% in 2021. CM rates in 2021 among low-risk patients were largely consistent across age groups (50-59: 85.1%; 60-69: 87.4%; 70+: 86.3%). For FIR patients, CM rates increased among the subset with Gleason 6 disease (49.5% in 2012 to 80.7% in 2021). In multivariable models, independent predictors of CM in low-risk patients included older age, more recent year, lower PSA at diagnosis, North Atlantic or Pacific region, and presence of another cancer at diagnosis; similar predictors were found in FIR patients. Self-reported race (Black, White, or Other) was not associated with CM. While there was wide geographic variation in CM rates among low-risk patients early in the study period (2012-2014: 56.1% in Southeast region vs 74.1% in Pacific), these disparities resolved in recent years (2019-2021: 83.2% in Southeast vs 83.8% in Pacific). Rates of conservative management for localized prostate cancer increased dramatically over time in the VA, with over 85% of low-risk patients managed conservatively in 2021. Recent years showed no differences in CM rates by self-reported race, geographic region, or age group. Despite this progress, we observed a concomitant increase in the proportion of men 70 years or older diagnosed with localized prostate cancer, including low risk disease. This raises a need to consider strategies to reduce the diagnosis of low-risk disease in elderly Veterans.

5-Years Analysis of Effectivity and Toxicity of Ultra-Hypofractionated Proton Radiotherapy in the Treatment of Low- and Intermediate-Risk Prostate Cancer-A Retrospective Analysis.

We retrospectively analyzed the 5-year biochemical disease-free survival (bDFS) and occurrence of late toxicity in prostate cancer patients treated with pencil beam scanning (PBS) proton radiotherapy. In the period from January 2013 to June 2018, 853 patients with prostate cancer were treated with an ultra-hypofractionated schedule (36.25 GyE/five fractions). The mean PSA value was 6.7 (0.7-19.7) µg/L. There were 318 (37.3%), 314 (36.8%), and 221 (25.9%) patients at low (LR), favorable intermediate (F-IR), and unfavorable intermediate risk (U-IR), respectively. Neoadjuvant hormonal therapy was administered to 197 (23.1%) patients, and 7 (0.8%) patients had adjuvant hormonal therapy. The whole group of patients reached median follow-up time at 62.7 months, and their mean age was 64.8 (40.0-85.7) years. The bDFS rates and late toxicity profile were evaluated. Median treatment time was 10 (7-38) days. Estimated 5-year bDFS rates were 96.5%, 93.7%, and 91.2% for low-, favorable intermediate-, and unfavorable intermediate-risk groups, respectively. Cumulative late toxicity (CTCAE v4.0) of G2+ was as follows: gastrointestinal (GI)-G2: 9.1%; G3: 0.5%; genitourinary (GU)-G2: 4.3%, and no G3 toxicity was observed. PSA relapse was observed in 58 (6.8%) patients: 16 local, 22 lymph node, 4 bone recurrences, and 10 combined sites of relapse were detected. Throughout the follow-up period, 40 patients (4.7%) died, though none due to prostate cancer. Ultra-hypofractionated proton beam radiotherapy is an effective treatment for low- and favorable intermediate-risk prostate cancer, with long-term bDFS rates comparable to other techniques. It is promising for unfavorable intermediate-risk prostate cancer and has acceptable long-term GI and favorable GU toxicity.

Aggressive Prostate Cancer in Patients Treated with Active Surveillance.

Active surveillance has emerged as a promising approach for managing low-risk and favorable intermediate-risk prostate cancer (PC), with the aim of minimizing overtreatment and maintaining the quality of life. However, concerns remain about identifying "aggressive prostate cancer" within the active surveillance cohort, which refers to cancers with a higher potential for progression. Previous studies are predictors of aggressive PC during active surveillance. To address this, a personalized risk-based follow-up approach that integrates clinical data, biomarkers, and genetic factors using risk calculators was proposed. This approach enables an efficient risk assessment and the early detection of disease progression, minimizes unnecessary interventions, and improves patient management and outcomes. As active surveillance indications expand, the importance of identifying aggressive PC through a personalized risk-based follow-up is expected to increase.

Current Trends in Incidence and Management of T1a and T1b Prostate Cancer.

Prostate cancer (PCa) identified incidentally (iPCa) after surgical treatment for symptomatic benign prostatic hyperplasia (BPH) causing lower urinary tract symptoms (LUTS) is considered low risk by the most current guidelines. Management protocols for iPCa are conservative and are identical to other prostate cancers classified as having favorable prognoses. The objectives of this paper are to discuss the incidence of iPCa stratified by BPH procedure, to highlight predictors of cancer progression, and to propose potential modifications to mainstream guidelines for the optimal management of iPCa. The correlation between the rate of iPCa detection and the method of BPH surgery is not clearly defined. Old age, small prostate volume, and high pre-operative prostate-specific antigen (PSA) are associated with an increased likelihood of detecting iPCa. PSA and tumor grade are strong predictors of cancer progression and can be used along with magnetic resonance imaging (MRI) and potential confirmatory biopsies to determine disease management. In instances that iPCa requires treatment, radical prostatectomy (RP), radiation therapy, and androgen deprivation therapy all have oncologic benefits but may be associated with increased risk after the BPH surgery. It is advised that patients with low to favorable intermediate-risk prostate cancer undergo post-operative PSA measurement and prostate MRI imaging before electing to choose between observation, surveillance without confirmatory biopsy, immediate confirmatory biopsy, or active treatment. Subdividing the binary T1a/b cancer staging into more categories with ranging percentages of malignant tissue would be a helpful first step in tailoring the management of iPCa.

Recommendations for patients with prostate cancer who wish to undergo a kidney transplant

Over the past half a century, kidney transplants have increased significantly and more patients that are elderly are receiving kidney transplants. As a result, the eligibility of patients with prostate cancer who wish to receive a kidney transplant has become a significant issue facing the transplant community. Many questions have arisen because prostate cancer is an extremely variable disease that many times do not harm the patients but at other times, can cause the death of the patient.If a patient has prostate cancer, should he be allowed to receive a kidney transplant? Should he receive the transplant after treatment for prostate cancer or without such treatment? How should the transplant community determine his eligibility? Most agree that those with high-risk prostate cancer should be treated first and have a waiting period prior to kidney transplant. Almost all low-risk prostate cancer patients are candidates for active surveillance. More and more urologists are doing active surveillance for favorable intermediate risk prostate cancer patients. We believe that all patients who are reasonable candidates for active surveillance based on the National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer are reasonable candidates for kidney transplant without treatment for prostate cancer. We recommend using a combination of shared-decision making that involves prostate cancer risk-stratification as well as adjunctive tests such as imaging with multiparametric MRI (mpMRI) and genomic testing such as Decipher, Oncotype DX or Polaris, in order to inform whether or not patients with prostate cancer can receive a kidney transplant without treatment for prostate cancer.

Variations in the Uptake of Active Surveillance for Prostate Cancer and Its Impact on Outcomes

BackgroundRegional differences in active surveillance (AS) uptake for prostate cancer (PC) illustrate an inequality in treatment strategies. ObjectiveTo examine the association between regional differences in AS uptake and transition to radical treatment, start of androgen deprivation therapy (ADT), watchful waiting, or death. Design, setting, and participantsA Swedish population-based cohort study was conducted including men in the National Prostate Cancer Register in Sweden with low-risk or favorable intermediate-risk PC, starting AS from January 1, 2007 and continuing till December 31, 2019. InterventionRegional tradition of low, intermediate, or high proportions of immediate radical treatment. Outcomes measurements and statistical analysisProbabilities of transition from AS to radical treatment, start of ADT, watchful waiting, or death from other causes were assessed. Results and limitationsWe included 13 679 men. The median age was 66 yr, median PSA 5.1 ng/ml, and median follow-up 5.7 yr. Men from regions with a high AS uptake had a lower probability of transition to radical treatment (36%) than men from regions with a low AS uptake (40%; absolute difference 4.1%; 95% confidence interval [CI] 1.0–7.2), but not a higher probability of AS failure defined as the start of ADT (absolute difference 0.4%; 95% CI –0.7 to 1.4). There were no statistically significant differences in the probability of transition to watchful waiting or death from other causes. Limitations include uncertainty in the estimation of remaining lifetime and transition to watchful waiting. ConclusionsA regional tradition of a high AS uptake is associated with a lower probability of transition to radical treatment, but not with AS failure. A low AS uptake suggests overtreatment. Patient summaryThere are considerable regional differences in active surveillance (AS) uptake for prostate cancer. This study compared the outcomes of AS in different regions and found no association between AS uptake and failure of AS; it suggests that a low AS uptake indicates overtreatment.

Use of Active Surveillance vs Definitive Treatment Among Men With Low- and Favorable Intermediate–Risk Prostate Cancer in the US Between 2010 and 2018

This cross-sectional study of data from the Surveillance, Epidemiology and End Results database assesses temporal trends in the use of active surveillance and watchful waiting vs definitive treatment in men with low- and favorable intermediate–risk prostate cancer in the US between 2010 and 2018.

PD32-12 VISUAL AND NUMERIC RISK INFORMATION REDUCES VARIATION IN SURGEON RISK PERCEPTION: RESULTS FROM A RANDOMIZED, CLINICAL VIGNETTE EXPERIMENT

You have accessJournal of UrologyCME1 Apr 2023PD32-12 VISUAL AND NUMERIC RISK INFORMATION REDUCES VARIATION IN SURGEON RISK PERCEPTION: RESULTS FROM A RANDOMIZED, CLINICAL VIGNETTE EXPERIMENT Hung-Jui Tan, David Gotz, Hillary Heiling, Allison Deal, Kara Giannone, Debra Usinger, Sue Blalock, Antonia Bennett, Matthew Nielsen, Daniel Reuland, Alex Sox-Harris, Allison Lazard, Greg Sacks, and Ethan Basch Hung-Jui TanHung-Jui Tan More articles by this author , David GotzDavid Gotz More articles by this author , Hillary HeilingHillary Heiling More articles by this author , Allison DealAllison Deal More articles by this author , Kara GiannoneKara Giannone More articles by this author , Debra UsingerDebra Usinger More articles by this author , Sue BlalockSue Blalock More articles by this author , Antonia BennettAntonia Bennett More articles by this author , Matthew NielsenMatthew Nielsen More articles by this author , Daniel ReulandDaniel Reuland More articles by this author , Alex Sox-HarrisAlex Sox-Harris More articles by this author , Allison LazardAllison Lazard More articles by this author , Greg SacksGreg Sacks More articles by this author , and Ethan BaschEthan Basch More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003325.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Differences in risk perception is a major driver of variation in surgery. Risk prediction tools aim to attenuate these differences, but only a minority of urologists use them. Because data visualization can improve engagement and information processing, we designed a visual risk display and tested its impact on surgeon risk perception. METHODS: Taking a user-centered design approach, the research team engaged a panel of urologists to identify key risk domains and design a visual risk display. From May–June 2022, we administered SUO/AUA members 6 clinical vignettes (A: favorable intermediate risk prostate cancer, B: high risk prostate cancer, C: small renal mass, D: advanced kidney cancer, E: BCG unresponsive, noninvasive bladder cancer, F: muscle-invasive bladder cancer), randomizing them to vignettes plus visual risk display, vignettes plus numeric risk information, and vignettes alone (control). Respondents estimated the risk for other-cause mortality, cancer mortality with/without surgery, serious complications, and adverse functional outcome from 0–100%. Variation was compared using Levene’s test of homogeneity in variance. RESULTS: In total, 333 urologists completed all 6 vignettes with 104 in the visual arm, 111 in the numeric arm, and 118 in the control arm. Most respondents obtained fellowship-training (71.2%) and practice in an academic setting (60.1%). Respondents had 11.7 (SD 10.6) years of experience and performed 11.2 (SD 9.7) major cases per month. As illustrated in the Figure 1, both visual and numeric risk information reduced variation in perceived risk of other-cause mortality (i.e., life expectancy) compared to control (p<0.05). Visual and numeric risk information yielded similar reductions in variation for the other risk domains. However, compared to numeric risk information only, the visual risk display only reduced variation in perceived risk for adverse functional outcomes for cases D, E, and F (p<0.05). CONCLUSIONS: Providing urologists with risk information—whether visual or numeric—reduces variation in perceived risk, particularly for life expectancy and functional outcomes. Additional research is needed to assess whether visual methods further enhance usability and risk communication in the clinical setting. Source of Funding: American Cancer Society © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e911 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hung-Jui Tan More articles by this author David Gotz More articles by this author Hillary Heiling More articles by this author Allison Deal More articles by this author Kara Giannone More articles by this author Debra Usinger More articles by this author Sue Blalock More articles by this author Antonia Bennett More articles by this author Matthew Nielsen More articles by this author Daniel Reuland More articles by this author Alex Sox-Harris More articles by this author Allison Lazard More articles by this author Greg Sacks More articles by this author Ethan Basch More articles by this author Expand All Advertisement PDF downloadLoading ...

PD32-08 THE EFFECT OF VISUAL AND NUMERIC RISK INFORMATION ON SURGEON BEHAVIOR: A RANDOMIZED, CLINICAL VIGNETTE EXPERIMENT

You have accessJournal of UrologyCME1 Apr 2023PD32-08 THE EFFECT OF VISUAL AND NUMERIC RISK INFORMATION ON SURGEON BEHAVIOR: A RANDOMIZED, CLINICAL VIGNETTE EXPERIMENT Hung-Jui Tan, David Gotz, Hillary Heiling, Allison Deal, Kara Giannone, Debra Usinger, Sue Blalock, Antonia Bennett, Matthew Nielsen, Daniel Reuland, Alex Sox-Harris, Allison Lazard, Greg Sacks, and Ethan Basch Hung-Jui TanHung-Jui Tan More articles by this author , David GotzDavid Gotz More articles by this author , Hillary HeilingHillary Heiling More articles by this author , Allison DealAllison Deal More articles by this author , Kara GiannoneKara Giannone More articles by this author , Debra UsingerDebra Usinger More articles by this author , Sue BlalockSue Blalock More articles by this author , Antonia BennettAntonia Bennett More articles by this author , Matthew NielsenMatthew Nielsen More articles by this author , Daniel ReulandDaniel Reuland More articles by this author , Alex Sox-HarrisAlex Sox-Harris More articles by this author , Allison LazardAllison Lazard More articles by this author , Greg SacksGreg Sacks More articles by this author , and Ethan BaschEthan Basch More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003325.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The treatment patients receive depends more on their surgeon than their disease. Risk prediction tools aim to address this quandary by providing quantitative risk information, but their clinical impact remains limited. Because data visualization can improve information processing, we designed a visual risk display and tested its impact on surgical decision-making. METHODS: We engaged a panel of urologists to develop a multidimensional, multifaceted visual risk display through user-centered design. The panel further helped us develop clinical vignettes for favorable intermediate risk prostate cancer (A), high risk prostate cancer (B), small renal mass (C), advanced kidney cancer (D), BCG unresponsive, noninvasive bladder cancer (E), and muscle-invasive bladder cancer (F) where surgical equipoise exist. From May–June 2022, we administered these vignettes to SUO and AUA members via Qualtrics, randomizing them to the visual risk display, numeric risk information, and control. Risk estimates were generated from existing risk prediction tools. For each case, respondents rated how likely they would recommend surgery (5-point Likert: strongly against to strongly for surgery) and selected health services they would obtain prior to surgery. Responses were compared using Fisher’s MC exact test with significance level set at 0.05. RESULTS: In total, 333 urologists participated: 104 in the visual arm, 111 in the numeric arm, and 118 in the control arm. Respondents were mostly fellowship-trained (71.2%) and in academic practices (60.1%). A strong or somewhat for surgery recommendation varied by case (A: 19.2%, B: 65.2%, C: 51.9%, D: 51.3%, E: 52.3%, F: 68.8%) but did not differ statistically across arms (p=0.210–0.967). In contrast, the selection of healthcare services such as preoperative care, cardiac clearance, and pulmonary clearance did differ statistically across arms depending on the case (Figure). CONCLUSIONS: Risk information—whether visual or numeric—did not affect a surgeon’s recommendation for surgery, highlighting the strong intuitive nature of surgical decision-making. However, the selection of health services appears more movable, indicating a role for risk prediction tools in optimizing surgical readiness and clinical outcomes. Source of Funding: American Cancer Society © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e910 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hung-Jui Tan More articles by this author David Gotz More articles by this author Hillary Heiling More articles by this author Allison Deal More articles by this author Kara Giannone More articles by this author Debra Usinger More articles by this author Sue Blalock More articles by this author Antonia Bennett More articles by this author Matthew Nielsen More articles by this author Daniel Reuland More articles by this author Alex Sox-Harris More articles by this author Allison Lazard More articles by this author Greg Sacks More articles by this author Ethan Basch More articles by this author Expand All Advertisement PDF downloadLoading ...