Partial Gland Ablation Research Articles

Oncological Outcomes of Partial Gland Ablation Using High-Intensity Focused Ultrasound After Additional Confirmatory Transperineal Mapping Biopsy in Men with Prostate Cancer

Background/Objectives: To evaluate whether additional confirmatory transperineal mapping biopsy (TPMB) in men with localized prostate cancer (PCa) alters the treatment plan and outcome of partial gland ablation (PGA) using high-intensity focused ultrasound (HIFU). Methods: We retrospectively reviewed data from 96 patients who underwent PGA using HIFU between January 2020 and June 2022. After multiparametric magnetic resonance imaging (mpMRI), all men underwent transrectal ultrasound (TRUS)-guided, cognitive-targeted biopsy and systematic biopsy. Men eligible for PGA using HIFU first underwent confirmatory TPMB. Any changes in the treatment plan after TPMB were analyzed. Follow-up TRUS-guided biopsy was performed 1 year post-operatively to evaluate oncological outcomes. Clinically significant PCa (csPCa) was defined as Gleason grade (GG) ≥ 2. Results: Among all subjects, the median age (IQR) was 65.0 (60.0–72.0) years and the prostate-specific antigen level was 5.20 (3.71–7.81) ng/mL. The results of both TRUS-guided biopsy and TPMB led to a change in the treatment plan (from unilateral to bilateral PGA) for 13 (13.5%) patients. The 1-year follow-up TRUS-guided biopsy identified PCa in 13 (13.5%) patients, and csPCa in 7 (7.3%) patients. The infield- and outfield-positive rates were 8.3% (8/96) and 3.1% (3/96), respectively, for any PCa, and 3.1% (3/96) and 2.1% (2/96), respectively, for csPCa. Conclusions: Confirmatory TPMB results in better disease identification and localization, thereby affecting the treatment plan and improving oncological outcomes. Therefore, confirmatory TPMB should be considered to establish an appropriate strategy for patients with localized PCa eligible for PGA using HIFU.

Comparative study of HIFU partial gland ablation and robot-assisted radical prostatectomy for localized prostate cancer: an evidence-based approach.

This research aims to use a data-driven analytical method to compare the effectiveness of High-Intensity Focused Ultrasound (HIFU) partial gland ablation with Robot-Assisted Radical Prostatectomy (RARP) for treating localized prostate cancer, evaluating variations in treatment results. We performed a systematic review of the literature, covering key databases including the Cochrane Library, PubMed, EMBASE, Web of Science, and Google Scholar, with the latest information updated until August 2024. We utilized Stata 18 for data analysis, computing weighted mean differences (WMDs) for continuous data and odds ratios (ORs) for categorical data, with all results reported alongside 95% confidence intervals (CIs). Additionally, the studies included were evaluated using the Newcastle-Ottawa Scale (NOS). This meta-analysis incorporated data from three paired studies, encompassing a total of 1,503 patients. Patients treated with HIFU experienced a shorter hospital stay (WMD = -2.78, 95%CI -5.14,-0.43; p = 0.02) compared to those who received RARP. Additionally, evaluations at 3 and 12months post-surgery revealed that the HIFU group exhibited better recovery in urinary continence and sexual function than the RARP group. However, there were no notable disparities in complication rates (OR = 1.48, 95%CI 0.92,2.40; p = 0.110) and the requirement for salvage therapy (OR = 2.92, 95%CI 0.60,14.33; p = 0.186) between the two treatment methods. In conclusion, this meta-analysis appears to suggest potential benefits of HIFU partial gland ablation in possibly reducing the length of hospital stays and seems to indicate that it might be associated with improved recovery in terms of urinary incontinence and sexual function, particularly during the early to mid-term postoperative period. Although the differences in complication rates and the requirement for salvage therapy between the two surgical methods were not statistically significant, the findings provided by this analysis are instrumental in guiding clinical decision-making.

MRI accuracy for recurrence after partial gland ablation with HIFU for localized prostate cancer. A systematic review and meta-analysis.

Prostate cancer remains the most frequently diagnosed cancer among men. High-Intensity Focused Ultrasound (HIFU) has emerged as a thermal ablative technique for partial-gland-ablation (PGA), aiming to minimize collateral damage while maximizing tumor control. Monitoring after HIFU PGA relies on serial PSA testing, multiparametric-MRI, and biopsies. The diagnostic accuracy of MRI for clinically-significant cancer(csPCa) recurrence is challenging. This systematic review and meta-analysis aim to evaluate the accuracy of MRI in detecting early recurrence of localized prostate cancer following HIFU PGA. Adhering to PRISMA guidelines, a comprehensive literature search was conducted until May 8th 2024 using MEDLINE and Scopus. The inclusion criteria encompassed randomized controlled trials and cohort studies involving men diagnosed with localized prostate cancer who had as primary treatment HIFU PGA. The primary outcome measures included the sensitivity, specificity, positive-predictive value (PPV), and negative-predictive value (NPV) of MRI for csPCa(ISUP ≥ 2) based on biopsy results. We pooled data from studies with sufficient csPCa and csPCa-free patients (≥5) post HIFU for statistical analysis. Fifteen studies meet the inclusion criteria, encompassing 1093 patients and 12 studies were eligible for meta-analysis. MRI sensitivity in detecting clinically-significant prostate cancer (csPCa) recurrence post HIFU PGA varied widely (0-89%), with a pooled sensitivity of 0.52 (95% CI:0.36-0.68). Specificity ranged from 44% to 100%, with a pooled specificity of 0.81 (95% CI:0.68-0.91). The pooled NPV was 0.82 (95% CI:0.72-0.90), and the pooled PPV was 0.50 (95% CI:0.35-0.65). Three studies reported in-field diagnostic performance with sensitivities ranging from 0.42 to 0.80 and specificities from 0.45 to 0.97. MRI accuracy for clinically-significant recurrence after partial gland ablation with HIFU for localized prostate cancer shows low diagnostic performance in the treated lobe with pooled sensitivity of 0.52 (95% CI:0.36-0.68) and specificity of 0.81 (95% CI:0.68-0.91). Limits of this review include the low number of studies reporting about site of recurrence in or out of the treated lobe.

Whole gland versus partial gland ablation in patients with localized prostate cancer treated by high-intensity focused ultrasound ablation

BackgroundFocal therapy is considered one of the treatment options for localized prostate cancer (PCa), particularly for low or very-low-risk patients. In this study, we compared the mid-term oncological outcomes in localized PCa patients treated with high-intensity focused ultrasound (HIFU). MethodsWe retrospectively analyzed 237 patients who underwent HIFU for localized PCa. Patients were divided into two groups based on ablation type: whole gland ablation (WGA) and partial gland ablation (PGA). Follow-up biopsies were performed after one year postoperatively, and the oncological outcomes were compared between the groups. ResultsAmong the total of 237 patients, 54 subjects were treated by WGA and 183 subjects by PGA. After one year postoperatively, follow-up biopsies were conducted on 199 patients, revealing residual cancer in 21.4% of WGA group and 15.3% of PGA group. Additionally, clinically significant (CS) cancer was observed in 14.3% of WGA group and 8.3% of PGA group. Survival analyses revealed significantly longer failure-free (P < 0.001) and salvage-free survival (P < 0.001) in WGA group than in PGA group. Similarly, in the intermediate—high risk group, WGA group exhibited longer failure-free (P = 0.005) and salvage-free survival (P < 0.001). ConclusionHIFU was performed with acceptable oncological outcomes in localized PCa. Despite higher proportion of high-risk patients in WGA group, WGA was associated with significantly better failure-free survival and salvage-free survival. Further prospective and multi-center studies are warranted.

Select black men are potential candidates for prostate hemi-ablation based on radical prostatectomy histopathology for intermediate-risk prostate cancer-a multicenter SEARCH cohort study.

Partial gland ablation (PGA) is increasingly popular as a treatment for men with intermediate-risk prostate cancer (IR-PCa) to preserve functional outcomes while controlling their cancer. We aimed to determine the impact of race and clinical characteristics on the risk of upstaging (≥pT2c) and having adverse pathological outcomes including seminal vesicle invasion (SVI), extra prostatic extension (EPE) and lymph node invasion (LNI) at radical prostatectomy (RP) among men with IR disease eligible for PGA with hemi-ablation (HA). Retrospective analysis. Multicenter. We studied patients diagnosed with unilateral IR-PCa treated with RP between 1988 and 2020 at 9 different Veterans Affairs hospitals within the SEARCH cohort. We analyzed differences in clinicopathological characteristics and outcome variables (odds of ≥pT2c and SVI, EPE and LNI) by race using multivariable logistic regression after adjusting for covariates. Among 3127 patients, 33% were African American (AA) men with unilateral IR-PCa undergoing RP. Compared to non-AA men, AA individuals were younger (61 vs. 65 years, p < 0.001), presented with a higher prostate specific antigen (PSA) category (≥10 ng/ml; 34 vs. 26%, p < 0.001), and had a lower clinical stage (p < 0.001). Among the 2,798 (89.5%) with ≥pT2c stage, AA men exhibited higher ≥ pT2c rates (93 vs. 89%, p < 0.001), primarily due to increased pT2c staging (64 vs. 57%), where upstaging beyond pT2 was lower than non-AA men (29 vs. 32%). On multivariable analysis, AA men were found to have higher odds of ≥pT2c (odds ratio [OR]: 1.39 CI, 1.02-1.88, p = 0.04), lower odds of EPE (OR: 0.73 CI, 0.58-0.91, p < 0.01) and no statistically significant associations with LNI (OR: 0.79 CI, 0.42-1.46, p = 0.45) and SVI (OR: 1 CI, 0.74-1.35, p = 0.99) compared to non-AA men. On multivariable analysis, clinical features associated with higher odds of ≥pT2c were pre-operative PSA ≥ 15 (OR = 2.07, P = 0.01) and higher number of positive cores (HPC) on biopsy (OR = 1.36, P < 0.001). Similarly, PSA ≥ 15, Gleason grade ≥3 and HPC on biopsy were associated with higher odds of SVI, EPE and LNI, respectively. In men with IR-PCa undergoing RP, AA men demonstrated an overall higher likelihood of ≥pT2c with lower upstaging beyond pT2, lower likelihood of EPE and no significant difference in likelihood of SVI and LNI compared to non-AA men. These findings support select AA men to be potential candidates for PGA, such as HA. Clinical factors are predictive of higher pathological stage and adverse pathological outcomes at RP and could be considered when selecting candidates for PGA.

Intraoperative margin assessment with near real time pathology during partial gland ablation of prostate cancer: A feasibility study

BackgroundIn-field or in-margin recurrence after partial gland cryosurgical ablation (PGCA) of prostate cancer (PCa) remains a limitation of the paradigm. Stimulated Raman histology (SRH) is a novel microscopic technique allowing real time, label-free, high-resolution microscopic images of unprocessed, un-sectioned tissue which can be interpreted by humans or artificial intelligence (AI). We evaluated surgical team and AI interpretation of SRH for real-time pathologic feedback in the planning and treatment of PCa with PGCA. MethodsAbout 12 participants underwent prostate mapping biopsies during PGCA of their PCa between January and June 2022. Prostate biopsies were immediately scanned in a SRH microscope at 20 microns depth using 2 Raman shifts to create SRH images which were interpreted by the surgical team intraoperatively to guide PGCA, and retrospectively assessed by AI. The cores were then processed, hematoxylin and eosin stained as per normal pathologic protocols and used for ground truth pathologic assessment. ResultsSurgical team interpretation of SRH intraoperatively revealed 98.1% accuracy, 100% sensitivity, 97.3% specificity for identification of PCa, while AI showed a 97.9% accuracy, 100% sensitivity and 97.5% specificity for identification of clinically significant PCa. 3 participants’ PGCA treatments were modified after SRH visualized PCa adjacent to an expected MRI predicted tumor margin or at an untreated cryosurgical margin. ConclusionSRH allows for accurate rapid identification of PCa in PB by a surgical team interpretation or AI. PCa tumor mapping and margin assessment during PGCA appears to be feasible and accurate. Further studies evaluating impact on clinical outcomes are warranted.

Comparative Effectiveness of Partial Gland Cryoablation Versus Robotic Radical Prostatectomy for Cancer Control

Background and objectiveThere is an absence of high-level evidence comparing oncologic endpoints for partial gland ablation, and most series used prostate-specific antigen (PSA) rather than biopsy endpoints. Our aim was to compare oncologic outcomes between partial gland cryoablation (PGC) and radical prostatectomy (RP) for prostate cancer. MethodsThis was a retrospective, single-center analysis of subjects treated with PGC (n = 98) or RP (n = 536) between January 2017 and December 2022 as primary treatment for intermediate-risk (Gleason grade group [GG] 2–3) prostate cancer. Oncologic endpoints included protocol surveillance biopsies after PGC in comparison to serial PSA testing after RP. The primary outcome was treatment failure, defined as a need for any salvage treatment or development of metastatic disease. Treatment failure and survival analyses were conducted using Cox proportional-hazard regression and Kaplan Meier survival curves. Key findings and limitationsAfter applying the inclusion/exclusion criteria, the PGC (n = 75) and RP (n = 298) groups were compared. PGC patients were significantly older (71 vs 64 yr; p < 0.001) but there were no differences in PSA, biopsy GG, or treatment year between the groups. The PGC group had higher rates of treatment failures at 24 mo (33% vs 11%; p < 0.001) and 48 mo (43% vs 14%; p < 0.001). One PGC patient (2.1%) and one RP patient (0.7%) had developed metastases by 48-mo follow-up (p = 0.4). On adjusted analysis, PGC was associated with a higher risk of treatment failure (hazard ratio 4.6, 95% confidence interval 2.7–7.9; p < 0.001). Limitations include observational biases associated with the retrospective study design. ConclusionsThis is the first comparative effectiveness study of cancer control outcomes for PGC versus RP. The results demonstrate an almost fivefold higher risk of treatment failure with PGC during short-term follow-up. Patient summaryWe compared cancer control outcomes for patients with intermediate-risk prostate cancer treated with partial prostate gland cryoablation versus radical prostatectomy. We found that partial gland cryoablation had an almost fivefold higher risk of treatment failure. Men with prostate cancer should be counseled regarding this difference in treatment failure.

Propensity score matched analysis of functional outcome in five thousand cases of robot-assisted radical prostatectomy versus high-intensity focused ultrasound

BackgroundTo evaluate functional outcome after robot-assisted radical prostatectomy (RARP) and high-intensity focused ultrasound (HIFU) ablation for prostate cancer. MethodsWe retrospectively reviewed 4,983 RARP and 230 HIFU procedures performed at a single tertiary center. A 1:4 ratio propensity score matching (PSM) was performed to achieve baseline equivalence in age, body mass index (BMI), comorbidities, clinical stage, prostate specific antigen (PSA), prostate volume, biopsy grade, and number of positive cores. Functional outcomes based on International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) scores, and incontinence rates were evaluated at 6, 12, and 24 months. Resultstotal of 193 HIFU cases matched to 760 cases of RARP, were included. No differences were observed in perioperative IPSS at all follow-up periods. Despite comparative erectile function at baseline, HIFU showed significantly better erectile function preservation compared to RARP, with mean IIEF-5 scores of 9.5 versus 4.8, 9.5 versus 5.8, and 8.4 versus 6.7 at 6, 12, and 24 months, respectively (all P < 0.001). Pad-free rates at 6 and 12 months were comparable, with over 96% achieving continence at 12 months in both groups, although the rate of ≤1 pad/day at last follow-up was slightly better in HIFU (98.9% vs. 96.7%, P = 0.049). Subgroup analysis on partial (PGA) and whole gland ablation (WGA) showed no differences in IIEF-5 and incontinence but increased voiding difficulty in WGA versus PGA after 12 months of therapy (P < 0.05). Preoperative IIEF-5 ≥17 and HIFU were significant predictors of early erectile function recovery at 6 months (HR 4.4 and 5.0; all P < 0.001). No differences were observed in treatment-free survival between PGA, WGA, and RARP. ConclusionHIFU shows better performance in early recovery and preservation of erectile function after treatment for prostate cancer without increasing the risk of treatment failure. Patients with moderate to severe erectile dysfunction (IIEF-5 <17) prior to surgery should be warned of poor recovery after treatment.

Partial gland ablation using high-intensity focused ultrasound versus robot-assisted radical prostatectomy: a propensity score-matched study.

We compared the clinical outcomes of robot-assisted radical prostatectomy (RARP) and partial gland ablation (PGA) using high-intensity focused ultrasound (HIFU) in localized prostate cancer. We analyzed 3,859 patients who had undergone RARP and PGA using HIFU. According to the propensity score for each treatment, 137 patients after PGA were matched to 3,722 patients after RARP at a 1:4 ratio using the nearest neighbor method. The matched cohort comprised 685 subjects (RARP, 548; PGA, 137), with a median follow-up period of 22months. Treatment failures were identified in 13.9% and 9.1% of patients in the PGA and RARP groups, respectively, after a median follow-up of 36months postoperatively. Kaplan-Meier analyses revealed significantly longer failure-free (P<0.001) and salvage-free survival (P=0.003) in the RARP group than in the PGA group. There was no significant difference in the postoperative urinary symptom score (P=0.748), but the postoperative erectile function score was significantly higher in the PGA group (P<0.001). The rate of urinary incontinence (any pad) was significantly lower in the PGA group than that in the RARP group (P<0.001). Postoperative complications were more frequent in the PGA group (P=0.003); however, there was no significant difference in high-grade complications (≥3) (P=0.467). PGA using HIFU showed statistically inferior oncological outcomes compared with RARP for failure-free survival and salvage-free survival. However, functional outcomes regarding postoperative incontinence and erectile dysfunction were more favorable in the PGA group.

Intermediate Grade Prostate Cancer and Risk for Adverse Pathology Radical Prostatectomy: Implications for Partial Gland Ablation Case Selection.

Using nationally representative data, we determined the likelihood of adverse pathology at radical prostatectomy (RP) to better inform case selection for partial gland ablation (PGA). We identified men with clinically localized GG2 (n=106,048) and GG3 (n=55,488) prostate cancer on biopsy from 2010 through 2019 who subsequently underwent RP. Men with GG2 were stratified as unfavorable and favorable per NCCN guidelines. RP adverse pathology was defined as upgrading to GG4-5, pT3-4, or nodal involvement (pN1), respectively. Logistic regression determined factors associated with adverse pathology, and the Cochran-Armitage Test was used to evaluate temporal trends. Men with biopsy GG3 vs. GG2 experienced significant upgrading (11.3% vs. 3.6%, P < .001), more EPE (26.9% vs. 21.1%), SVI (11.9% vs. 5.3%), and pN1 (4.3% vs. 1.6%), all P < .001. When comparing unfavorable vs. favorable GG2, men experienced more EPE (25.3% vs. 16.5%), SVI (7.2% vs. 3%), and pN1 (2.2% vs. 0.8%), all P < .001. In adjusted analysis, age, Hispanic race, PSA > 10 ng/mL, and ≥ 50% positive biopsy cores were associated with adverse pathology (all P < .001). The likelihood of RP adverse pathology for men with biopsy GG3 increased significantly during the study period from 38.8% in 2010 to 47.3% in 2019 (P < .001). Approximately 40% of men with GG3 and more than 30% with unfavorable GG2 prostate cancer harbor adverse pathology that may not be curable by PGA. Given MRI often understages prostate cancer, our findings have significant implications for optimizing PGA case selection and cancer control outcomes.

Partial-gland Cryoablation Outcomes for Localized Prostate Cancer in Patients with Magnetic Resonance Imaging (MRI)-visible and MRI-invisible Lesions

BackgroundExpert consensus recommends treatment of magnetic resonance imaging (MRI)-visible prostate cancer (PCa). Outcomes of partial-gland ablation (PGA) for MRI-invisible PCa remain unknown. ObjectiveTo compare recurrence-free survival, adverse events, and health-related quality of life (HRQoL) outcomes following cryoablation of MRI-visible vs invisible PCa. Design, setting, and participantsWe analyzed data for 75 men who underwent cryoablation therapy between January 2017 and January 2022. PCa identified on MRI-targeted and/or adjacent systematic biopsy cores was defined as MRI-visible, whereas PCa identified on systematic biopsy beyond the targeted zone was defined as MRI-invisible. Outcome measurements and statistical analysisThe primary outcome was recurrence at 12 mo after PGA, defined as the presence of clinically significant PCa (grade group [GG] ≥2) on surveillance biopsy. Adverse events were captured using the Clavien-Dindo classification and HRQoL was captured using the Expanded Prostate Cancer Index-Clinical Practice (EPIC-CP) tool. Results and limitationsOf the 58 men treated for MRI-visible and 17 treated for MRI-invisible lesions, 51 (88%) and 16 (94%), respectively, had at least one surveillance biopsy performed. There were no statistically significant differences in age, race, body mass index, biopsy GG, prostate-specific antigen, prostate volume, or treatment extent between the MRI-visible and MRI-invisible groups. Median follow-up was 44 mo (interquartile range 17–54) and did not significantly differ between the groups. The recurrence rate at 12 mo did not significantly differ between the groups (MRI-visible 39%, MRI-invisible 19%; p = 0.2), and log-rank survival analysis demonstrated no significant difference in recurrence-free survival (p = 0.15). Adverse event rates did not significantly differ (MRI-visible 29%, MRI-invisible 53%; p = 0.092); no man in the MRI-visible group had a Clavien-Dindo grade ≥III complication, while one subject in the MRI-invisible group had a Clavien-Dindo grade III complication. Median EPIC-CP urinary and sexual function scores were similar for the two groups at baseline and at 12 mo after PGA. Study limitations include the retrospective design and small sample size. ConclusionsWe observed similar cancer control, adverse event, and HRQoL outcomes for MRI-visible versus MRI-invisible PCa in the first comparison of partial-gland cryoablation. Longer follow-up and external validation of our findings are needed to inform patient selection for PGA for MRI-invisible PCa. Patient summaryPatients with prostate cancer lesions that are not visible on magnetic resonance imaging (MRI) scans who undergo partial gland ablation may have similar treatment outcomes compared to patients with cancer lesions that are visible on MRI.

MP73-01 DOES MRI OR PSA PREDICT BIOPSY OUTCOME AFTER FOCAL CRYOTHERAPY FOR PROSTATE CANCER?

You have accessJournal of UrologyCME1 Apr 2023MP73-01 DOES MRI OR PSA PREDICT BIOPSY OUTCOME AFTER FOCAL CRYOTHERAPY FOR PROSTATE CANCER? Wayne Brisbane, Mamdouh Aker, Lorna Kwan, Samantha Gonzalez, Alan Priester, Adam Kinnaird, Merdie Delfin, Ely Felker, Anthony Sisk, and David Kupperman Wayne BrisbaneWayne Brisbane More articles by this author , Mamdouh AkerMamdouh Aker More articles by this author , Lorna KwanLorna Kwan More articles by this author , Samantha GonzalezSamantha Gonzalez More articles by this author , Alan PriesterAlan Priester More articles by this author , Adam KinnairdAdam Kinnaird More articles by this author , Merdie DelfinMerdie Delfin More articles by this author , Ely FelkerEly Felker More articles by this author , Anthony SiskAnthony Sisk More articles by this author , and David KuppermanDavid Kupperman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003341.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We sought to determine the value of MRI and serum PSA levels in prediction of targeted biopsy results after partial gland ablation (PGA) of intermediate-risk prostate cancer (PCa) using cryotherapy (CRYO). METHODS: In a prospective, observational trial (NCT03503643), 143 men with unilateral PCa (all >GG2) were enrolled. PSA and MRI-guided biopsy (MRGB) was performed before and after PGA with CRYO. CRYO treatment was a 2-cycle freeze of the affected prostate part using argon gas delivered via transperineal needles under image guidance. Participants underwent MRI/US fusion biopsy at baseline to determine eligibility; at 6 months to determine technical success; and at 18 months. Fusion MRGB in follow-up at 6 and 18 months employed tracking technology (JAMA Open: 31509206). Successful ablation=absence of PCa >GG2 on MRGB. Effects on urinary and sexual function were studied via EPIC-CP. RESULTS: 95% of enrollees (136/143) completed f/u MRGB at 6 mo; 103 had a successful ablation (74%). Of the 103, 71 then had 18-mo f/u MRGB; success rate at 18 mo was 46/71 (65%); among 25 failures at 18 months, PCa was ipsilateral in 8, contralateral in 12, and bilateral in 5. Baseline MRI lesions (PIRADS >3) disappeared post-CRYO in 96/130 men (74%); PCa was found in 22/96 (23%) with no lesion and 11/34 (32%) with lesions (p=NS). In a mult-variate analysis, lesion diameter was the only parameter related to biopsy outcome. PSA levels were similar (p=NS) before and after CRYO in successful and failed treatments (FIGURE), as was PSA density. After CRYO, urinary function changed but little, or improved; overall sexual function decreased in 53/143 (39%), but only 10/143 men reported a severe decrement (>6 point decline). CONCLUSIONS: In the near to intermediate term, PGA with cryotherapy is a safe and moderately effective treatment of intermediate-risk PCa, when outcome is judged by MRGB. Neither PSA nor MRI, at baseline or during follow-up, appear reliable as indicators of post-treatment tissue findings. We postulate the treatment per se alters prostate anatomy and physiology in a manner that obscures a relationship between either test and pathological outcome. Source of Funding: This work was supported in part by the National Cancer Institute (R01CA195505), UCLA CTSI (UL1TR000124), the Jean Perkins Foundation, the Kent Kresa Family Foundation, and the Steven C. Gordon Family Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1034 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Wayne Brisbane More articles by this author Mamdouh Aker More articles by this author Lorna Kwan More articles by this author Samantha Gonzalez More articles by this author Alan Priester More articles by this author Adam Kinnaird More articles by this author Merdie Delfin More articles by this author Ely Felker More articles by this author Anthony Sisk More articles by this author David Kupperman More articles by this author Expand All Advertisement PDF downloadLoading ...

Partial gland ablation outcomes for localized prostate cancer in patients with MRI-visible and MRI-invisible lesions.

368 Background: Partial gland ablation (PGA) for MRI-invisible prostate cancer (PCa) remains controversial, and we compared treatment failure rates, adverse events, and health-related quality-of-life outcomes (HRQoL) following PGA in subjects with MRI-visible vs. MRI-invisible lesions. Methods: Retrospective review was done of primary PGA therapy (cryoablation, irreversible electroporation, and high-intensity focused ultrasound) performed between January 2017 and 2022 at Weill Cornell Medical Center. Analysis was restricted to men with at least one post-PGA prostate biopsy. Men with PCa on systematic biopsy outside of the MRI-targeted zone were categorized as having MRI-invisible lesions. Failure of PGA was defined as persistence or recurrence of Gleason grade group (GGG) ≥2 on surveillance biopsy for subjects diagnosed with GGG ≥2 PCa. For patients treated for GGG 1 PCa, failure was defined by the detection of GGG ≥1 PCa. Adverse events were captured by the Clavien-Dindo classification and HRQoL outcomes were captured by the Expanded Prostate Cancer Index-Clinical Practice (EPIC-CP). Groups were compared using Pearson’s chi-squared test and the 2-sided Wilcoxon-Mann-Whitney test. Results: Out of 115 men were treated for primary prostate cancer, 89 men had at least one surveillance biopsy performed, and 87 men had available pre-treatment MRI data. Out 79 subjects treated with MRI-visible lesions and 34 subjects treated with MRI-invisible lesions, 59 and 28 subjects, respectively, had surveillance biopsy data. Median (IQR) follow-up was 15.5 months (7.7-25.5) in the overall cohort; median follow-up was not significantly different between the MRI-visible and MRI-invisible groups (15 vs. 15 months, p-value=0.766). Failure of PGA occurred in 43 (48.3%) of total subjects. Failure of PGA was not significantly different between the MRI-visible and MRI-invisible groups (50.9% vs. 42.9%, p-value=0.502). Mean total EPIC-CP scores were not significantly different between both groups at baseline, 3, 6, and 12 months after PGA. Additionally, rates of 30-day complications were not significantly different between both groups. Conclusions: Failure is evident in almost half of patients treated with PGA therapy. Oncologic and functional treatment outcomes after focal therapy are similar between patients with MRI-visible and MRI-invisible lesions. [Table: see text]

Cryotherapy for partial gland ablation of prostate cancer: Oncologic and safety outcomes.

Partial gland ablation (PGA) is a new option for treatment of prostate cancer (PCa). Cryotherapy, an early method of PGA, has had favorable evaluations, but few studies have employed a strict protocol using biopsy endpoints in men with clinically significant prostate cancer (csPCa). 143 men with unilateral csPCa were enrolled in a prospective, observational trial of outpatient PGA-cryotherapy. Treatment was a 2-cycle freeze of the affected prostate part. Participants were evaluated with MRI-guided biopsy (MRGB) at baseline and at 6 months and 18 months after treatment. Absence of csPCa upon MRGB was the primary endpoint; quality-of-life at baseline and at 6 months after treatment was assessed by EPIC-CP questionnaires in the domains of urinary and sexual function. Of the 143 participants, 136 (95%) completed MRGB at 6 months after treatment. In 103/136 (76%), the biopsy revealed no csPCa. Of the 103, 71 subsequently had an 18-month comprehensive biopsy; of the 71 with 18-month biopsies, 46 (65%) were found to have no csPCa. MRI lesions became undetectable in 96/130 (74%); declines in median serum PSA levels (6.9 to 2.5 ng/mL), PSA density (0.15 to 0.07), and prostate volume (42 to 34cc) were observed (all p< 0.01). Neither lesion disappearance on MRI nor PSA decline correlated with biopsy outcome. Urinary function was affected only slightly and sexual function moderately. In the near to intermediate term, partial gland ablation with cryotherapy was found to be a safe and moderately effective treatment of intermediate-risk prostate cancer. Eradication of cancer was better determined by MRI-guided biopsy than by MRI or PSA.

Thermal Partial Prostate Ablation for Intermediate- and High-risk Prostate Cancer: Con

Thermal partial-gland ablation (TPGA) is a promising treatment option for patients with prostate cancer (PCa) that has an excellent side-effect profile. However, the literature on TPGA in high-risk PCa is not robust enough to discount the risk of undertreatment and understaging in this population. Future studies, especially with incorporation of advanced imaging to better select patients, are necessary to understand the safety and efficacy of TPGA in high-risk disease.

Partial Gland Ablation of Prostate Cancer: Effects of Repeat Treatment

To evaluate the near-term clinical and pathological effects of repeat partial gland ablation (PGA) in men with intermediate-risk prostate cancer (PCa). One hundred seventy men with focal lesions of PCa (all GG2 or GG3) underwent PGA with high-intensity focused ultrasound (HIFU) or cryotherapy (CRYO) in prospective trials. Residual PCa in or near the ablation zone was found in 37 men after a first PGA; 30 went on to receive a second PGA and were the subjects of study. At 3 timepoints, baseline and 6 months after first and second ablations, quality-of-life (QOL) questionnaires (IIEF, IPSS) and MRI-guided biopsies (MRGB) were performed. Biopsies were targeted and systematic at baseline and in follow-up, comprehensively about the ablation zone. All 30 patients completed QOL questionnaires and 26 had MRGB at the 3 timepoints. Mean QOL scores were not significantly different from the baseline after the first or second PGA. No operative complications were encountered; and "decisional regret" was reported in only 2/29 men after the repeat ablation. A decrease in semen volume was reported by 25% of patients. Repeat ablation was successful (absence of csPCa on MRGB) in 14/26 (53%) of men. PSA levels decreased and MRI lesions resolved after ablations, but neither was a reliable predictor of biopsy outcomes. When initial PGA fails, repeat PGA is a reasonable consideration, because in near-term follow-up, secondary procedures appear to be safe, causing only minimal detriment to urinary and sexual function, with csPCa becoming undetectable by MRGB in approximately half the patients.

Salvage partial gland ablation for recurrent prostate cancer following primary partial gland ablation: Functional and oncological outcomes.

Partial gland ablation (PGA) for localised prostate cancer (CaP) aims to eradicate clinically significant tumours while preserving healthy tissue, thereby decreasing the likelihood of side effects compared to whole-gland approaches. Although salvage radical prostatectomy (sRP) is a well-described salvage option in cases of PGA failure, the evidence supporting salvage PGA (sPGA) is limited. We hereby report the oncologic and functional outcomes of patients treated with sPGA following initial treatment with primary PGA (pPGA). We describe the findings of a retrospective review of patients who had a CaP recurrence after pPGA and then underwent sPGA, at 3 medical centers in Ontario, Canada, between 2005 and 2017. Oncological outcomes following sPGA were assessed for biochemical recurrence (BCR) and biopsy-proven recurrence (BPR). Functional outcomes were described using the international prostate symptom score (IPSS), international index of erectile function (IIEF), and rates of urinary incontinence (use of >1 pad/day). We identified 25 patients who underwent sPGA following pPGA (hemiablation in 48% and zonal ablation in 52% of the patients). The median length of time was 16.8 months (interquartile range [IQR] 14.0-19.1) from pPGA to sPGA and 47.06 months (IQR 19.9-171.3) from pPGA to date of last follow up. High intensity focused ultrasound (HIFU) was the only modality used in all patients. At baseline, the median age was 65 years (IQR 52-77) and median prostate specific antigen (PSA) level was 7.46 ng/mL (IQR 1-25). The median time from pPGA to BPR was 12.7 months (IQR 5.19-36). At BPR following pPGA, 4 patients (17%) had CaP grade group (GG) 1, 10 patients (42%) had GG2, 6 patients (25%) had GG3, and 4 patients (17%) had GG4 disease, with a median PSA of 3.58 ng/mL (IQR 0.67-19). The median length of follow up after sPGA was 27.3 months (IQR 14.5-86.3). Following sPGA, 13/25 patients (52%) had BCR with median time to recurrence of 14 months (IQR 2.5-82.15), with a recurrence-free survival of 24.5 months (95% confidence interval: 15.3-not reached). Of those 13 patients, 4 were managed with sRP, 4 were managed with salvage radiotherapy, 3 were managed with androgen-deprivation therapy, 1 had a third PGA with HIFU, and 1 was managed with active surveillance. The mean change from baseline to last follow up in IPSS and IIEF scores was +1.3 (P = 0.66) and -2.3 (P = 0.32), respectively. Urinary incontinence was reported by 9% of patients at baseline, with only one additional patient developing incontinence following sPGA. Our present study demonstrates that after a median follow-up of 27 months, sPGA for recurrent CaP following pPGA provides disease control in up to 50% of patients with nonsignificant detrimental effects on functional outcomes. Appropriate patient selection and adequate staging are important to consider before offering PGA to patients.

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

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. Subjects 2years 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 > 6mm on contralateral systematic biopsy. 18F-Fluciclovine PET MRI imaging of the prostate was performed followed by in and out-of-field biopsies. 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. At 2years 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 2years following PPGCA.

Outcomes of partial gland ablation using high intensity focused ultrasound for prostate cancer.

To evaluate the clinical and oncological outcomes of partial gland ablation (PGA) using high intensity focused ultrasound (HIFU) technique for the clinically unilateral prostate cancer. We performed a retrospective analysis for the 163 patients who treated by PGA for clinically unilateral prostate cancer. The PGA was performed using Focal one system with concurrent trans-urethral prostatectomy. The oncological and functional outcomes were evaluated as well as risk factors for remnant disease after PGA. Clinically significant cancer was defined as grade group ≥2. Among the entire subjects, grade group 2 or greater was present at pre-treatment biopsy in 76.7%. Median follow-up time was 17 months and 60.1% of total subjects had follow-up biopsy at postoperative 1 year. There were 25 subjects (24.2%) with any cancer and 13 subjects (12.6%) with CS cancer at the follow-up biopsy. The preoperative age and number of positive cores at preoperative biopsy were significantly associated with positive results at follow-up biopsy. Incontinence which requires 2 or more pads per day was observed at 4 subjects (2.5%) postoperatively. There were no subjects who needed intensive care or experienced rectal complications. The PGA with HIFU was safe and showed good preservation of functional outcomes as well as satisfactory oncological control. The remnant disease was observed in the 24.5% of patients who underwent follow-up biopsy in the present study. Thus, further prospective study is needed to evaluate oncological and functional outcomes of PGA with HIFU more accurately.

MO-0299 Determination of the optimal nadir PSA following partial gland ablation in prostate brachytherapy

MO-0299 Determination of the optimal nadir PSA following partial gland ablation in prostate brachytherapy