Antibiotic resistance in patients undergoing serial prostate biopsies: risk factors and impact on clinical outcomes.

INTRODUCTION: We evaluate the rate of developing ciprofloxacin resistance in patients undergoing repeat prostate biopsies (PBx), associated risk factors, and impact on complications. MATERIALS AND METHODS: We retrospectively evaluated pre-procedural rectal culture (RCx) data in men undergoing PBx from 1/1/2016 to 1/15/2021. Univariate and multivariate logistic regression were utilized to identify risk factors associated with development of antibiotic resistance. Complication rates were compared between ciprofloxacin-sensitive and ciprofloxacin-resistant patients. RESULTS: A total of 743 men underwent initial RCx. Initial RCx detected ciprofloxacin resistance in 22% of patients. A history of diabetes (p = 0.01), > 2 prior prostate biopsies (p = 0.01), and ciprofloxacin use (p = 0.002) were significant risk factors for ciprofloxacin resistance on initial RCx. The rate of new ciprofloxacin resistance following biopsy with standard ciprofloxacin prophylaxis on 1st and 2nd exposure was 17.2% and 9.1% respectively. The number of biopsy cores, interval antibiotic exposure and interval procedures performed between first and second RCx were not significant predictors of developing ciprofloxacin resistance. Patients who received a non-ciprofloxacin antibiotic between first and second RCx did not develop ciprofloxacin resistance. Antibiotic resistance profile did not significantly affect the rate or type of complications after various prostate procedures. CONCLUSIONS: Serial exposure to standard antibiotic prophylaxis for PBx and associated procedures can lead to development of ciprofloxacin resistance after each subsequent exposure. This carries important implications for serial biopsy and highlights the role for RCx prior to repeat biopsy.

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

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.

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

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.

Two Year Functional Outcomes Stratified According to Baseline Erectile Function Following Partial Gland Cryo-Ablation.

OBJECTIVE: To critically evaluate time dependent sexual function following primary partial gland cryo-ablation (PGCA) stratified according to baseline erectile function. METHODS: Between March 2017 and March 2022, all men undergoing primary PGCA by 2 surgeons were enrolled in an IRB approved outcomes registry. All subjects with PIRADS 2-5 lesion concordant with unilateral GGG 1-3 disease, no gross extra-prostatic extension on mpMRI, GGG >1 contralateral to the ROI, or distal apical disease on mpMRI were enrolled. Patients completed the Sexual Health Inventory for Men (SHIM) scale at baseline, 6, and 24 months. Men were stratified by baseline erectile function. Men with SHIM Score < 8 were excluded. Ability to sustain erection (aka "potency") was defined as a score of 3 or greater on question 2 of the SHIM index. Median SHIM scores and the proportion of men reporting "potency" at baseline, 6, and 24 months was recorded with comparisons between each timepoint. A univariate analysis was used to determine if clinical factors were associated with loss of "potency" at 24 months. RESULTS: 106 men met the inclusion criteria. There was a statistically significant decrease in the mean SHIM scores for the entire cohort between baseline to 6 months and baseline to 24 months. SHIM scores increased significantly for the total cohort between 6 and 24 months. "Potency" was preserved in 70% at 24 months. CONCLUSION: Those patients most likely to exhibit a decrease in sexual function have moderate ED at baseline. Only baseline ED was shown to predict preservation of "potency".

A Prospective Pilot Study Investigating Performance of 18F-Fluciclovine PET Imaging for Detection of Prostate Cancer 2 Years Following Primary Partial Gland Cryoablation.

Purpose: The goal of partial gland ablation (PGA) is to eradicate focal lesions of clinically significant prostate cancer (csPCa) with minimal adverse impact on functional outcomes. The primary objective of this study is to characterize the performance of 18F-Fluciclovine PET imaging for detection of prostate cancer following PGA. Materials and Methods: Subjects 2 years following primary partial gland cryoablation (PPGCA) were invited to participate in an IRB-approved study providing they met the following inclusion criteria: a single reported mpMRI region of interest (ROI) concordant with biopsy Gleason Grade Group (GGG) < 4, no gross extra-prostatic extension on mpMRI, and no GGG > 1 or GGG 1 with a core length > 6 mm on contralateral systematic biopsy. 18F-Fluciclovine PET MRI imaging of the prostate was performed followed by in and out-of-field biopsies. Results: Twenty-seven men who met eligibility criteria participated in the prospective study. In-field and out-of-field csPCa recurrence rate was 7.4% and 22.2%, respectively. The sensitivity and positive predictive value of mpMRI and PET imaging did not reach performance to reliably inform who should undergo prostate biopsy. Conclusion: At 2 years following PPGCA, the rate of in-field csPCa was exceedingly low indicating a limited role for imaging to inform in-field biopsy decisions. The csPCa detection rate of out-of-field recurrence was 22% which provides an opportunity for imaging to inform out-of-field biopsy decisions. Based on our findings, 18F-Fluciclovine PET MRI cannot be used to inform who should undergo out-of-field prostate biopsy at 2 years following PPGCA.

Early functional outcomes following partial gland cryo-ablation.

INTRODUCTION: Given the increasing interest in partial gland cryo-ablation as a treatment modality and the lack of data surrounding urinary and sexual outcomes after the procedure, the goal of this analysis was to assess functional outcomes following partial gland cryo-ablation (PGCA) stratified according to baseline severity of lower urinary tract symptoms (LUTS) and erectile function (EF). A secondary goal was to also determine if there were any clinical factors associated with significant change in LUTS and EF. MATERIALS AND METHODS: Since 3/2017, all men undergoing primary PGCA were offered enrollment into an IRB-approved prospective outcomes registry. Men were given International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM) surveys prior to and 6 months post treatment. Differences in IPSS and SHIM scores are described, and factors associated with clinically significant change were assessed using univariate and multivariate analysis. RESULTS: A total of 100 men completed 6 month follow up. The mean IPSS for the overall cohort decreased 2.1 units (p > 0.05). The mean changes in IPSS for men with baseline mild, moderate, and severe LUTS were 0.9 (p = 0.06), -4.2 (p = 0.001), and -11.1(p = 0.001) units, respectively. The mean changes in the SHIM score for all men were - 5.1 units (p = 0.001). The mean changes in SHIM score for baseline none, mild/mild-to-moderate, moderate-severe ED were -7.6 (p = 0.001), -6.5 (p = 0.001) and -1.1 units (p = 0.27), respectively. No variables of interest were significantly associated with changes in IPSS or SHIM scores. CONCLUSION: Stratifying functional outcomes according to baseline IPSS and SHIM is imperative to assess the true impact of PGCA on functional outcomes.

Early oncological control following partial gland cryo-ablation: a prospective experience specifying reflex MRI guided biopsy of the ablation zone.

BACKGROUND: Several consensus statements recommend serial serum prostate-specific antigen (PSA), multi parametric magnetic resonance imaging (mpMRI), and prostate biopsy following partial gland ablation. We determined the rate of persistent in-field disease following primary partial gland cryo-ablation and whether PSA or mpMRI are reliable predictors of in-field disease persistence. METHODS: Between March 2017 and July 2019, subjects meeting eligibility criteria for partial gland cryoablation were enrolled into an IRB approved outcomes registry. PSA, mpMRI, and prostate biopsy (four cores targeting the ablation zone + six ipsilateral systematic cores) were performed per protocol 6 months following intervention. Binary logistic regression was employed to calculate odds ratio (OR) of PSA decrease, and suspicious mpMRI effect on cancer persistence. The performance of mpMRI for predicting in-field persistence of PCa was evaluated by area under the receiver operation characteristics curve (AUC). RESULTS: Of the 83 eligible men undergoing partial gland cryoablation, 70 (84.3%) underwent 6-month protocol prostate biopsy. Five (7.1%) biopsies exhibited any in-field disease persistence. Only one (1.4%) of these cancers was Gleason grade > 1. Neither PSA decrease or suspicious mpMRI reliably predicted cancer persistence, with OR of 1.6 (0.25-8.6) and 1.5 (0.02-1.3), respectively. AUC of mpMRI for predicting in-field disease persistence was 0.554. CONCLUSIONS: In this cohort of patients undergoing partial gland cryo-ablation, the incidence of persistent disease was low. PSA and mpMRI were not reliable predictors of in-field disease persistence. Based on these data, consideration may be given to deferring early follow-up biopsy in appropriate patients.