Whole-gland Ablation Research Articles

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.

High-intensity focused ultrasound strategies for treating prostate cancer.

Prostate cancer (PCa) is a significant health concern globally, necessitating effective treatment options. Typical treatment methods for early stage, particularly localized PCa, encompass radical procedures, such as radical prostatectomy (RP) and radiotherapy (RT), and nonradical focal therapy (FT). FT is a focused approach mainly used for treating small lesions limited to a specific zone of the prostate. Its objective is to achieve cancer control when minimizing damage to benign tissue. High-intensity focused ultrasound (HIFU) is one of the most used modalities in FT for the management of PCa. The progress in HIFU technology showcases continuous advancements, offering clinicians a variety of strategies to cater to diverse patient requirements. The advancements include the development of transrectal and transurethral HIFU machines that offer enhanced treatment distances, magnetic resonance imaging (MRI) fusion capabilities, real-time monitoring, and precise ablation. These improvements contribute to increased treatment effectiveness and better outcomes for patients. This narrative review aims to summarize the use of HIFU technology and its evolution, offering diverse options to clinicians, and explores the safety, effectiveness, and quality of different HIFU strategies, such as whole-gland ablation, hemigland ablation, and focal ablation. We conclude that nonwhole-gland HIFU offers similar cancer control with better short-term functional outcomes and fewer complications compared to whole-gland ablation. Combining HIFU with transurethral resection of the prostate (TURP) improves urinary function and reduces catheterization time. Focal ablation and hemigland ablation show promise in achieving cancer control when preserving continence and potency.

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.

Outcomes of salvage robot-assisted radical prostatectomy in patients who had primary focal versus whole-gland ablation: a multicentric study.

In the present study, we present comparative outcomes of radical prostatectomy after whole-gland therapy (wg-SRARP) and focal gland therapy (f-SRARP). The study assessed 339 patients who underwent salvage robot-assisted radical prostatectomy (SRARP); 145 patients who had primary focal therapy and 194 patients who had primary whole-gland treatment. SRARP was performed in all cases using a standardized technique developed at respective institutes with the da Vinci Xi Surgical System. Our primary endpoint was the comparison of the functional and oncological outcomes between the groups. Cox proportional hazard was used to study the functional and oncological outcomes. The median total operative time for f-SRARP was 18min higher than wg-RARP (p < 0.001). Higher rates of nerve-sparing were performed in f-SRARP (focal vs whole gland; bilateral-15.2% vs 9.3%; unilateral 49% vs 28.4%; p < 0.001). wg-SRARP had higher rates of ISUP 5 (26.3% vs 19.3%; p < 0.001) and deferred ISUP score due to altered pathology (14.8% vs 0.7; p < 0.001), while f-SRARP had higher rates of ISUP 4 (11.7% vs 10.7%; p < 0.001) and ≥ pT3a (64.8% vs 51.6%; p < 0.001). Positive margins were significantly higher with f-SRARP (26.2% vs 10.3%; p < 0.001). Functional outcomes were poor in both the groups. However, postoperative continence was higher and faster in patients who had f-SRARP compared to wg-SRARP (69% vs. 54.6%; p = 0.013). We could not identify statistically significant difference in postoperative potency recovery and biochemical recurrence. We present the largest multi-institutional analyses of f-SRARP and wg-SRARP. SRARP is challenging wherein patients have adverse pathological features and increased surgical complexity irrespective of the primary treatment. Focal therapy group had higher rates of nerve-sparing, however, with increased positive surgical margins. Both groups had poor functional outcomes regardless of nerve-sparing degree, indicating significant ipsilateral and contralateral damage to tissues surrounding the prostate during primary treatment. We believe that this analysis is crucial for counseling patients regarding expected outcomes before performing a salvage treatment following ablative therapy failure.

MP73-17 WHOLE GLAND ABLATION USING HIGH-INTENSITY FOCUSED ULTRASOUND VERSUS ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY SCORE-MATCHED STUDY

You have accessJournal of UrologyCME1 Apr 2023MP73-17 WHOLE GLAND ABLATION USING HIGH-INTENSITY FOCUSED ULTRASOUND VERSUS ROBOT-ASSISTED RADICAL PROSTATECTOMY: A PROPENSITY SCORE-MATCHED STUDY Jin Noh, Gyoohwan Jung, Hae Sung Lee, Jun Hyun Nam, Jung Kwon Kim, Sangchul Lee, Seong Jin Jeong, Jong Jin Oh, Seok-Soo Byun, Sung Kyu Hong, and Hakmin Lee Jin NohJin Noh More articles by this author , Gyoohwan JungGyoohwan Jung More articles by this author , Hae Sung LeeHae Sung Lee More articles by this author , Jun Hyun NamJun Hyun Nam More articles by this author , Jung Kwon KimJung Kwon Kim More articles by this author , Sangchul LeeSangchul Lee More articles by this author , Seong Jin JeongSeong Jin Jeong More articles by this author , Jong Jin OhJong Jin Oh More articles by this author , Seok-Soo ByunSeok-Soo Byun More articles by this author , Sung Kyu HongSung Kyu Hong More articles by this author , and Hakmin LeeHakmin Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003341.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We compared the clinical outcomes of robot-assisted radical prostatectomy (RARP) and whole gland ablation (WGA) using high-intensity focused ultrasound (HIFU) in localized prostate cancer. METHODS: We analyzed 3,806 patients who had undergone RARP and WGA using HIFU. According to the propensity score for each treatment, 84 patients after WGA were matched to 3,722 patients after RARP at a 1:4 ratio using the nearest neighbor method. RESULTS: The matched cohort comprised 420 subjects (RARP, 336; PGA, 84), with a median follow-up period of 26 months. Treatment failures were identified in 16.7% and 15.5% of patients in the WGA and RARP groups, respectively. Kaplan-Meier analyses revealed no significantly failure-free (p=0.999) and salvage-free survival (p=0.548) in the RARP group than in the WGA group. There was no significant difference in the postoperative urinary symptom score (p=0.630), but the postoperative erectile function score in group of preoperative international index of erectile function (IIEF)≥17 was significantly higher in the WGA group (p=0.030). The rate of urinary incontinence (any pad) was lower in the WGA group than that in the RARP group (10.7% vs 20.2%, p=0.057). Postoperative complications were more frequent in the WGA group (p<0.001); however, there was no significant difference in high-grade complications (≥3) (p=0.201). CONCLUSIONS: WGA using HIFU showed statistically similar oncological outcomes compared with RARP for failure-free survival and salvage-free survival. However, functional outcomes regarding erectile function in selective group and postoperative incontinence were more favorable in the WGA group. Source of Funding: N/A © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1042 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jin Noh More articles by this author Gyoohwan Jung More articles by this author Hae Sung Lee More articles by this author Jun Hyun Nam More articles by this author Jung Kwon Kim More articles by this author Sangchul Lee More articles by this author Seong Jin Jeong More articles by this author Jong Jin Oh More articles by this author Seok-Soo Byun More articles by this author Sung Kyu Hong More articles by this author Hakmin Lee More articles by this author Expand All Advertisement PDF downloadLoading ...

MP73-05 PIVOTAL STUDY OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION (TULSA) OF LOCALIZED PROSTATE CANCER: 4-YEAR FOLLOW UP

MP73-05 PIVOTAL STUDY OF MRI-GUIDED TRANSURETHRAL ULTRASOUND ABLATION (TULSA) OF LOCALIZED PROSTATE CANCER: 4-YEAR FOLLOW UP

PD60-08 OUTCOMES OF SALVAGE ROBOTIC-ASSISTED RADICAL PROSTATECTOMY COMPARING PATIENTS WITH PRIMARY FOCAL THERAPY VERSUS WHOLE GLAND ABLATION: A MULTICENTRIC COLLABORATIVE DATA

You have accessJournal of UrologyCME1 May 2022PD60-08 OUTCOMES OF SALVAGE ROBOTIC-ASSISTED RADICAL PROSTATECTOMY COMPARING PATIENTS WITH PRIMARY FOCAL THERAPY VERSUS WHOLE GLAND ABLATION: A MULTICENTRIC COLLABORATIVE DATA Seetharam Bhat Kulthe Ramesh, Arjun Nathan, Marcio Moschovas, Senthil Nathan, and Vipul Patel Seetharam Bhat Kulthe RameshSeetharam Bhat Kulthe Ramesh More articles by this author , Arjun NathanArjun Nathan More articles by this author , Marcio MoschovasMarcio Moschovas More articles by this author , Senthil NathanSenthil Nathan More articles by this author , and Vipul PatelVipul Patel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002645.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Introduction With increasing experience, surgeons worldwide have increasingly used Salvage Robotic-assisted Radical Prostatectomy as a tool to treat patients who failed previous non-surgical treatment for prostate cancer. Our study compared the outcomes of salvage radical prostatectomy from two high-volume centers from the US and UK in patients who failed prior treatment with whole gland ablation (SRARP) and focal therapy (fSRARP). METHODS: The study assessed 339 patients compared in two groups: 145 patients who had primary focal therapy and 194 patients who had primary whole gland treatment. SRARP was performed in all cases using a standardized technique developed at respective institutes with the da Vinci Xi Surgical System. Our primary endpoint was the comparison of the functional and oncological outcomes between the groups. RESULTS: The median total operative time for fSRARP was 18 mins higher than SRARP (P <0.001). Significantly higher rates of nerve-sparing was performed in fSRARP (focal vs whole gland; bilateral – 15.2% vs 9.3%; unilateral 49% vs 28.4%; p <0.001). SRARP group had higher rates of ISUP GGp 5 (26.3% vs 19.3%; p <0.001) and deferred ISUP score due to altered pathology (14.8% vs 0.7; p <0.001) while fSRSRP had higher rates of ISUP GGp 4 (11.7% vs 10.7%; p <0.001) and ≥pT3a (64.8% vs 51.6%; p <0.001). Also, fSRARP had higher rates of positive surgical margins (26.2% vs 10.3%; p <0.001). Fig 1 shows a cox regression proportional hazard model for BCR excluding PSA persistence showsa trend towards higher postoperative BCR probability in patients who had SRARP (p= 0.534). Fig 2 shows a cox regression proportional hazard model reporting the probability of postoperative continence shows higher and faster recovery in patients who had fSPARP compared to SRARP (p=0.013). There was no difference in trends of postoperative potency probability in both groups (p=0.997) (Fig 3). CONCLUSIONS: Salvage robotic-assisted radical prostatectomy is challenging wherein patients have adverse pathological features irrespective of primary treatment. Focal therapy group had higher rates of nerve-sparing with increased positive surgical margins. However, both groups had poor functional outcomes regardless of nerve-sparing degree, indicating significant collateral and contralateral damage to tissues surrounding the prostate. We believe that this analysis is crucial for counseling patients regarding expected outcomes before performing a salvage treatment following non surgical local therapy failure. Source of Funding: Nil © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1028 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Seetharam Bhat Kulthe Ramesh More articles by this author Arjun Nathan More articles by this author Marcio Moschovas More articles by this author Senthil Nathan More articles by this author Vipul Patel More articles by this author Expand All Advertisement PDF DownloadLoading ...

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer: A Systematic Review.

Purpose:MRI-guided transurethral ultrasound ablation (TULSA) uses real-time MR thermometry feedback to target prostate disease. We systematically review the literature to synthesize efficacy, functional, and safety outcomes and assess the influence of planned ablation fraction on outcome.Materials and Methods:PubMed, Embase, and the Cochrane Library were searched from inception to June 2021 following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies reporting at least one efficacy, functional, or safety outcome after a single TULSA treatment were included. The relationship of freedom from salvage treatment and potency preservation with planned ablation volume was modeled.Results:Two hundred twenty-four patients were treated in 10 studies with up to a 5-year follow-up, mainly for primary localized prostate cancer (PCa) plus smaller cohorts with recurrent PCa, and locally advanced PCa (LAPC). The prostate-specific antigen decline from baseline up to 2 years, including focal to whole-gland ablation plans, was 54% to 97%. The rate of salvage treatment after one TULSA treatment for primary PCa was 7% to 17%. Continence and potency preservation were from 92% to 100% and from 75% to 98%. Urinary symptoms were stable in men with good voiding function at baseline, and 85% of men with concurrent PCa and lower urinary tract symptoms met the criteria for improvement. Symptom relief in a small cohort of men with LAPC was observed. Grade III adverse events were incurred by 13/224 men (6%), with no rectal injury/fistula or Grade IV complication. The planned ablation fraction was linearly related to salvage-free survival. The relationship between potency preservation and planned ablation fraction followed a sigmoid curve.Conclusions:As an alternative to conventional treatments, TULSA is safe and effective for prostate tissue ablation in men with primary PCa. There is also evidence that TULSA delivers effective relief of urinary symptoms while treating PCa in a single, low-morbidity procedure. The likelihood of freedom from additional treatment or potency preservation is associated with the planned ablation fraction.

High Intensity Focused Ultrasound Ablation for Prostate Cancer: Whole Versus Partial Gland Ablation.

We compared the clinical outcomes between whole-gland ablation (WGA) and partial gland ablation (PGA) using the high-intensity focused ultrasound (HIFU) technique for localized prostate cancer (PCa). We retrospectively investigated 206 patients who underwent WGA or PGA for localized PCa. Follow-up prostatic biopsy was performed 1 year postoperatively. We performed intergroup comparison of the postoperative functional and oncological outcomes and complication rates. In this study, 152 and 54 patients underwent PGA and WGA, respectively. The total operation time was significantly longer in the WGA than in the PGA group (107.5 minutes vs. 95.0 minutes, P=.004). Of the 86 patients who underwent postoperative prostate biopsy, no residual cancer was detected in 70.4% of the WGA and 72.9% of the PGA group. Incontinence-free survival was significantly shorter in the PGA than in the WGA group (P= .047); however, no significant intergroup difference was observed in erectile dysfunction-free survival (P= .317). The postoperative adverse event rate was significantly lower in the PGA than in the WGA group (37.5% vs. 66.7%, P=.023). Of the total patients investigated, 43 (20.9%) required additional endoscopic surgery for bladder outlet obstruction, and the additional endoscopic surgery rate was significantly higher in the WGA than in the PGA group (35.2% vs. 15.8%, P=.005). HIFU treatment was associated with acceptable oncological and fair functional outcomes in patients with localized PCa. Moreover, PGA was associated with significantly better clinical outcomes, including the faster recovery of urinary incontinence and adverse effects.

Outcomes of Salvage Robot-assisted Radical Prostatectomy After Focal Ablation for Prostate Cancer in Comparison to Primary Robot-assisted Radical Prostatectomy: A Matched Analysis

BackgroundFocal therapy (FT) for prostate cancer is less invasive than radical treatment but carries a risk of recurrence. Salvage robot-assisted radical prostatectomy (S-RARP) is a possible option after FT failure. ObjectiveTo evaluate the impact of FT on functional and oncological outcomes following S-RARP. Design, setting, and participantsIn a retrospective analysis of data from a prospectively collected institutional database, 53 patients who underwent S-RARP following failure of focal ablation were selected as group I; patients who had whole-gland ablation and external beam therapy were excluded. This group was matched to a control sample (matched at ratios of 1:1, 1:2, 1:3, 1:4) of men who had undergone primary RARP, using age, prostate-specific antigen (PSA), PSA density, body mass index, Sexual Health Inventory for Men score, American Urological Association symptom score, Charlson comorbidity index, prostate weight, preoperative Gleason score (GS), and history of smoking as variables. Surgical procedureS-RARP after FT was performed using a standardized technique developed at our institute with the da Vinci Xi Surgical System. MeasurementsOncological and functional outcomes were compared between the S-RARP and primary RARP groups. Results and limitationsThere was no difference in estimated blood loss (p = 0.8) between the 1:1 matched groups, but operating room time was significantly longer for S-RARP (p = 0.007). The primary RARP group had a higher proportion of patients who underwent a full nerve-sparing procedure. The S-RARP group had higher incidence of positive surgical margins (40% vs 15%; p = 0.008), GS ≥8 (25% vs 15%; p = 0.07), and positive lymph node status (9.4% vs 5.7%; p = 0.02). There was no significant difference in overall complications between the groups. The primary RARP group had a higher incidence of lymphocele drainage after surgery (15% vs 0%; p = 0.006). The main limitation of the study is its retrospective design. ConclusionsS-RALP after FT failure is feasible; however, surgery following FT leads to poorer oncological and functional outcomes. Despite the targeted nature of FT, significant nonfocal collateral damage is evident in tissues surrounding the prostate, which in turn translates to poorer functional outcomes after S-RARP. Patient summaryWe studied the surgical challenges during robot-assisted removal of the prostate after previous focal treatment (FT) for prostate cancer and compared the outcomes to those for robot-assisted prostate removal in patients who had no previous FT. We found that this technique is safe and effective with a limited risk of complications, but poor urinary and sexual functional outcomes.

Early Effects of High-intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer on Fecal Continence and Anorectal Physiology

To evaluate high-intensity focused ultrasound (HIFU) effects on anorectal physiology and fecal continence or constipation, and on quality of life (QoL). We prospectively evaluated 26 patients with localized prostate cancer who underwent HIFU. The Rome III criteria for functional constipation, the Cleveland Clinic Florida Fecal Incontinence Score, and the Fecal Incontinence QoL Score questionnaires were answered before and after treatment. Anorectal manometry was used to evaluate resting and squeezing pressures, sustained contraction, paradoxical puborectalis contraction, rectal sensation, and rectal capacity. Thirteen patients underwent hemiablation and 13 underwent whole-gland ablation. There was no difference between groups regarding the Rome III criteria for functional constipation results. The Cleveland Clinic Florida Fecal Incontinence Score results showed that 3 (11.5%) of patients had mild fecal incontinence before HIFU and 5 (19.2%) had it afterward (P=.625). No patients reported poor QoL due to fecal incontinence in the Fecal Incontinence QoL Score. Anorectal manometry demonstrated no decrease in resting pressure after treatment (P=.299), while squeezing pressure significantly increased from 151.87 to 167.91 mm Hg (P=.034). The number of patients with normal sustained contraction remained the same (20 [77%]). Paradoxical puborectalis contraction was seen in 12 (46%) of the patients before the procedure and in 13 (50%) after (P=.713). Improvement in sensory parameters was not significant: first sense changed from 73.46 to 49.71 mL (P=.542) and first urge from 98.27 to 82.88 mL (P=.106). Rectal capacity had a nonsignificant decrease from 166.15 to 141.15mL (P=.073). HIFU did not cause significant changes in anorectal physiology. Fecal incontinence or constipation after HIFU was not observed via validated questionnaires.

Long-term outcomes of two ablation techniques for treatment of radio-recurrent prostate cancer.

In men with recurrence of prostate cancer post radiation therapy, further treatment remains a challenge. The default salvage option of androgen-deprivation therapy (ADT) has adverse effects. Alternatively, selected men may be offered salvage therapy to the prostate. Herein, we present long-term oncological outcomes of two whole-gland ablation techniques, cryotherapy (sCT) and high-intensity-focused ultrasound (sHIFU). Men undergoing sCT (1995-2004) and sHIFU (2006-2018) at Western University were identified. Oncological endpoints included biochemical recurrence (BCR), ADT initiation, metastases, castration resistance (CRPC), and prostate cancer-specific mortality (PCSM). Survival analysis with competing risks of mortality was performed. Multivariable analysis was performed using Fine and Gray regression. A total of 187 men underwent sCT and 113 sHIFU. Mean (SD) age of the entire cohort was 69.9 (5.9 years), median pre-radiation PSA 9.6 ng/ml (IQR 6.1-15.2), and pre-salvage PSA 4.5 ng/ml (IQR 2.8-7.0). Median total follow-up was 116 months (IQR 67.5-173.8). A total of 170 (57.6%) developed BCR, 68 (23.4%) metastases, 143 (49.3%) were started on ADT, 58 (20.1%) developed CRPC, and 162 (56%) patients died of which 59 (36.4%) were of prostate cancer. On multivariable analysis, sHIFU (HR 1.65, 95% CI 1.15-2.36, p = 0.006) and pre-salvage PSA (HR 1.09, 95% CI 1.06-1.13, p < 0.0001) were associated with a higher risk of BCR. Similarly, sHIFU patients had a higher risk of CRPC (HR 2.31, 95% CI 1.23-4.35, p = 0.009). The cumulative incidence (for both treatments) of PCSM was 16.5% (95% CI 12.2-21.4%) at 10 years and 28.4% (95% CI 22.1-34.9%) at 20 years, with no difference between treatment modalities. Pre-salvage PSA was a common predictor for the measured oncological outcomes. Although sHIFU had higher BCR and CRPC rates, there were no differences in PCSM when compared with sCT. The long-term oncological data on two ablation techniques highlighted that only 50% of patients started ADT after 10-year follow-up.

Survival and quality of life outcomes of high-intensity focused ultrasound treatment of localized prostate cancer.

BackgroundTo evaluate the survival and quality of life (QoL) outcomes of high-intensity focused ultrasound (HIFU) whole-gland ablation for localized prostate cancer.MethodsOver 8 years, men with localized prostate cancer treated with whole-gland HIFU were prospectively followed. Transrectal prostate ablation was performed under general anesthesia with Sonablate-500® (Sonacare Medical©, Charlotte, North Carolina, USA). The primary outcome was failure-free survival defined as no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer–specific mortality. Secondary outcomes included both survival outcomes and QoL measures.ResultsOf 70 men, 29.7% had International Society of Urological Pathology (ISUP) grade 1, 43.8% ISUP 2, 10.9% ISUP 3, and 15.6% ISUP 4 disease. At median follow-up of 83.4 months, overall mortality was 8.6% and prostate cancer–specific mortality 0%. Failure-free survival was 78.2% at 5 years and 71.2% at 7 years. Of all men, 7.1% of men developed metastases, with median metastasis-free survival of 75.4 months. There was negligible post-HIFU urinary incontinence or lower urinary tract symptom with a median Male Urogenital Distress Inventory score of 32 at 6 months and 33 at 12 months and median IPSS of 4 at 6 months and 3 at 12 months. Median Radiation Therapy Oncology Group rectal toxicity score was 0 throughout. In men who had mild or no erectile dysfunction at baseline (International Index of Erectile Function ≥17), the mean International Index of Erectile Function score declined to 37% from 23.5 at baseline to 14.7 at 12 months.ConclusionAt median follow-up of 7 years, whole-gland HIFU appears to have comparable survival outcomes with other cohort studies involving radical prostatectomy and radiotherapy patient. It has low impact on QoL, preserved urinary continence, and erectile function approximate to nerve-sparing prostatectomy. Whole-gland HIFU presents a potential alternative minimally invasive and safe option for the treatment of localized prostate cancer.

3:45 PM Abstract No. 341 Pivotal study of magnetic resonance imaging–guided transurethral ultrasound ablation in men with localized prostate cancer: 12-month clinical and imaging outcomes

MRI-guided transurethral ultrasound ablation (TULSA) is an incision-free in-bore procedure for customized prostate ablation using directional thermal ultrasound under real-time MRI thermometry guidance and control. We report 12-month outcomes from the TULSA-PRO Ablation Clinical Trial (TACT) pivotal study. TACT enrolled 115 men with localized prostate cancer at 13 sites. Treatment intent was whole-gland ablation sparing the urethra and urinary sphincter. Primary endpoints were adverse events and proportion of men with PSA reduction ≥75%. Secondary endpoints included 12-month 10-core biopsy, mpMRI and prostate volume reduction assessed by a central radiology lab, and quality of life. Median (IQR) age was 65 (59-69) years and PSA 6.3 (4.6-7.9) ng/mL. Pretreatment, 72/115 men had Gleason grade group 2 (GG2) disease. PI-RADSv2 score ≥3 lesions were present in 98/115 (85%) men, ≥4 in 77 (67%). Ablation times were 51 (39-66) min. MRI thermometry during treatment measured 98% (95-99%) thermal coverage with ablation precision of ± 1.4 mm, confirmed by immediate posttreatment CE-MRI. Grade 3 adverse events occurred in 8% of men (all resolved), with no rectal injuries or grade ≥4 events. At 12 months, 1% of men were incontinent (>1 pad/day), and 69/92 (75%) maintained erections sufficient for penetration (IIEF Q2 ≥2). PSA reduction ≥75% was achieved in 110/115 (96%), with median reduction of 95% and nadir of 0.34 ng/mL. Median (IQR) perfused prostate volume decreased from 37 (27-48) cc to 3 (2-5) cc at 12-month MRI. Of 68 men with baseline GG2 disease, 54 (79%) were free of GG2 on 12-month biopsy. Overall, 72/111 (65%) had no evidence of any cancer. Of 98 men with PI-RADSv2 ≥3 at baseline, 26 had MRI lesions at 12 months, 11/26 with biopsy-confirmed GG2 (negative predictive value, NPV, 93%). Multivariate predictors of residual GG2 included intraprostatic calcifications at screening, MRI thermal coverage, and PI-RADSv2 ≥3 at 12 months (P <0.05). The TACT Pivotal study of MRI-guided TULSA for whole-gland ablation in men with localized prostate cancer met its primary PSA endpoint, with low rates of toxicity and residual disease. MRI at 12 months detected residual GG2 disease with NPV of 93%.

Whole-gland ablation therapy versus active surveillance for low-risk prostate cancer: a prospective study.

IntroductionThe objective of this study is assess the outcomes of whole-gland ablation (high-intensity focused ultrasound (HIFU), cryotherapy and brachytherapy) and active surveillance (AS) in patients with low-risk prostate cancer (PCa).Material and methodsThis prospective non-randomised study included 155 patients with low-risk PCa managed with either ablative therapy or AS. Follow-up included mpMRI, biopsies, prostate-specific antigen (PSA), quality of life and complications for up to 24 months. The primary endpoint was cancer progression. The secondary endpoint was the impact of each treatment on the quality of life.ResultsMean total preoperative PSA was 8.8 ±1.5 ng/ml. Of 155 patients, 125 received treatment: 45 – HIFU; 45 – cryoablation; 35 – brachytherapy. Thirty were under AS. Mean nadir PSA levels were 0.64 ±0.55 ng/ml for HIFU, 0.53 ±0.38 ng/ml for cryoablation and 0.48 ±0.34 ng/ml for brachytherapy. In the AS group, mean PSA was 9.9 ±3.8 ng/ml. Biochemical relapse-free survival rates at 24 months were 81.8% for HIFU, 85% for cryoablation, 93.9% for brachytherapy and 93.3% for AS. In only one HIFU patient relapse was not confirmed on biopsy. Increased anxiety was found in up to 6.7% after treatment and in 36.7% of patients undergoing AS. The Kaplan-Meier analysis revealed no statistical differences between the techniques.ConclusionsWhole-gland ablative therapy can be considered a viable treatment modality for carefully selected patients with low-risk PCa who are reluctant to select AS due to anxiety.

Salvage high-intensity focused ultrasound for locally recurrent prostate cancer after low-dose-rate brachytherapy: oncological and functional outcomes.

To evaluate the oncological and functional outcomes of salvage high-intensity focused ultrasound (S-HIFU) for locally recurrent prostate cancer after low-dose-rate (LDR) brachytherapy. Clinical phase II studies (2003-2015) included 50 consecutive patients with post-brachytherapy local recurrence treated by S-HIFU. S-HIFU was performed with post-external beam radiotherapy (EBRT) parameters and, since 2008, with specific post-brachytherapy parameters. Treatments were whole-gland ablation and, since 2009, hemi-ablation in cases of unilateral prostate cancer. The primary objective was to assess oncological outcomes: treatment failure-free survival, progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), and metastasis-free survival (MFS) rates. The secondary objective was to evaluate adverse events, continence, and erectile function. Kaplan-Meier analysis estimated oncological outcomes. In all, 13 patients were treated with post-EBRT parameters, 37 with post-brachytherapy parameters, 35 with whole-gland treatment, and 15 with hemi-ablation. The median follow-up was 4.6years. After S-HIFU, the median prostate-specific antigen level was 0.3ng/mL. At 6years, treatment failure-free survival, PFS, OS, CSS, and MFS rates were 41%, 45%, 93%, 98%, and 80%, respectively. Post-brachytherapy compared with post-EBRT parameters reduced Grade 2-3 incontinence (34% vs 62%, P=0.015). Incontinence, bladder outlet obstruction and Grade ≥III complications were significantly reduced with hemi-ablation compared with whole-gland treatment (14% vs 54%, P<0.001; 13% vs 46%, P=0.03; 13% vs 63%, P=0.001; respectively). Before S-HIFU, 25 patients had a five-item version of the International Index of Erectile Function score of ≥17, which was maintained in 48% at 12months. S-HIFU for locally recurrent prostate cancer after LDR brachytherapy is associated with favourable survival rates at a price of significant morbidity. Dedicated post-brachytherapy parameters and hemi-ablation improve the safety of the treatment.

Complications, oncological and functional outcomes of salvage treatment options following focal therapy for localized prostate cancer: a systematic review and a comprehensive narrative review

Whether focal therapy (FT) jeopardizes subsequent prostate cancer (PCa) salvage treatments, when needed, remains a major concern and is largely unknown. To describe and report safety, oncological and functional outcomes of salvage treatments following PCa recurrence and/or persistence after FT. A systematic review on salvage treatments for PCa recurrence/persistence after FT was carried out according to the PRISMA guidelines using an 'a priori protocol'. A comprehensive literature review was also performed to investigate options to treat FT PCa recurrence/persistence that have not yet been reported after FT. Four retrospective series were included (n = 67 men); overall quality of the studies was low. Salvage treatments yielded 32.8% (n = 22 of 67) biochemical recurrence rate (BCR) after a 7-62-months mean follow-up. No cancer-related deaths occurred. Patients experienced acceptable complications (n = 12 patients; n = 8 Clavien 3) and rare severe incontinence (4.5% using >2 pads/day). Erectile function (EF) was rarely assessed (62.8% no information available), being overall poor. Other salvage options have been reported following whole-gland ablation and include: (1) re-do ablation yielding worst BCR and EF but similar complications and continence compared to first line ablation; (2) salvage radiotherapy yielding 16.6-38.8% BCR and acceptable toxicity profile with urinary and EF being poorly assessed. Current evidence is weak and limited to a few retrospective series. Oncological control is acceptable although it seems lower compared to a primary treatment setting. Functional outcomes are comparable to primary treatment with the exception of EF; overall, suggesting FT has little impact on subsequent salvage treatments. Future studies are needed to confirm the current findings.

Propensity Score-Matched Comparison of Partial to Whole-Gland Cryotherapy for Intermediate-Risk Prostate Cancer: An Analysis of the Cryo On-Line Data Registry Data.

To compare the oncologic and functional outcomes of partial vs whole-gland cryotherapy for men with intermediate-risk prostate cancer. Men with intermediate-risk prostate cancer treated with primary prostate cryotherapy from 1993 to 2013 were selected from the Cryo On-Line Data Registry for a 1:1 matched comparison between those undergoing whole-gland and partial prostate cryotherapy (targeted ablation, unilateral/bilateral nerve-sparing ablations). A propensity score was developed based on age, prebiopsy serum prostate-specific antigen, biopsy Gleason score, clinical stage, prostate volume, neoadjuvant androgen deprivation status, year of surgery, and pretreatment potency. Outcomes were biochemical progression-free survival (BPFS) using the American Society for Therapeutic Radiation Oncology (ASTRO) and Phoenix criteria, 12-month continence (strictly pad free), and sexual function (potency sufficient for sexual intercourse). After propensity score matching, BPFS was compared using Kaplan-Meier analysis and functional outcomes using chi-square tests. In all, 897 men were identified (731 whole gland and 166 partial). Postmatching, 166 pairs of men were analyzed (mean follow-up 31 months). The 2/5-year BPFS rate was 87.2%/76.4% for whole-gland vs 80.7%/70.0% for partial ablation using Phoenix (p = 0.26) and 72.3%/69.6% for whole-gland vs 82.1%/75.0% for partial ablation using ASTRO criteria (p = 0.10). Of 164 pairs, the 12-month continence rate was similar, 94.1% vs 95.1% (p = 0.803). Of 139 pairs, the 12-month rate of effective intercourse was 29.5% for whole-gland and 46.8% for partial ablation (odds ratio 2.1, p = 0.003). The incidence of post-treatment urinary retention was 6.0% and 6.6% (p = 0.88) following whole-gland and partial ablation, respectively, and that of rectourethral fistula was 1.2% and 0% (p = 0.50). Partial ablation results in better post-treatment sexual function compared with whole-gland ablation in men with intermediate-risk prostate cancer. We did not observe a difference in early BPFS between the two groups.

MP18-18 MAGNETIC RESONANCE IMAGING-GUIDED TRANSURETHRAL ULTRASOUND PROSTATE ABLATION IN PATIENTS WITH LOCALIZED PROSTATE CANCER: 18-MONTH OUTCOMES OF A PROSPECTIVE PHASE I STUDY

You have accessJournal of UrologyProstate Cancer: Localized: Ablative Therapy1 Apr 2016MP18-18 MAGNETIC RESONANCE IMAGING-GUIDED TRANSURETHRAL ULTRASOUND PROSTATE ABLATION IN PATIENTS WITH LOCALIZED PROSTATE CANCER: 18-MONTH OUTCOMES OF A PROSPECTIVE PHASE I STUDY Joseph Chin, James Relle, Jason Hafron, Lonel Popeneciu, Timur Kuru, Michele Billia, Khurram Siddiqui, Matthias Roethke, Cesare Romagnoli, Mathieu Burtnyk, Heinz-Peter Schlemmer, and Sascha Pahernik Joseph ChinJoseph Chin More articles by this author , James RelleJames Relle More articles by this author , Jason HafronJason Hafron More articles by this author , Lonel PopeneciuLonel Popeneciu More articles by this author , Timur KuruTimur Kuru More articles by this author , Michele BilliaMichele Billia More articles by this author , Khurram SiddiquiKhurram Siddiqui More articles by this author , Matthias RoethkeMatthias Roethke More articles by this author , Cesare RomagnoliCesare Romagnoli More articles by this author , Mathieu BurtnykMathieu Burtnyk More articles by this author , Heinz-Peter SchlemmerHeinz-Peter Schlemmer More articles by this author , and Sascha PahernikSascha Pahernik More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2719AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES MRI-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally-invasive technology for ablation of prostate tissue, both malignant and benign. The aim of this Phase I study was to assess the safety and feasibility of MRI-TULSA for whole-gland ablation in the primary treatment setting of patients with localized prostate cancer. METHODS A single-arm, prospective Phase I study was performed at three tertiary referral urology centers in Canada, United States and Germany. Thirty men with biopsy-proven organ confined prostate cancer (cT1c-T2a, PSA ≤ 10 ng/ml, Gleason Score 3+3, ≤ 3+4 in Canada only) were treated (March 2013 - March 2014). MRI-TULSA was delivered under general anesthesia, with therapeutic intent of conservative whole-gland ablation, including 3 mm safety margins at the gland periphery, and 10% residual viable prostate expected around the capsule. Patients (pts) were followed at 1, 3, 6 and 12 months (mo), with visits every 6 mo thereafter. Primary endpoints were safety (adverse events), and feasibility (spatial precision of conformal ablation on MRI Thermometry). Exploratory outcomes included quality of life, PSA, MRI and 12-core TRUS-guided biopsy at 12 mo. RESULTS Median (IQR) age was 69 (67-71) years and PSA 5.8 (3.8-8.0) ng/ml, with 24 (80%) low-risk and 6 (20%) intermediate-risk cancers (D'Amico). Treatment time was 36 (26-44) min and prostate volume 44 (38-48) cc. Spatial control of ablation was ± 1.3 mm. Adverse events (CTCAE v4) included haematuria (14 pts G1; 2 pts G2), urinary tract infections (10 pts G2), acute urinary retention (3 pts G1; 5 pts G2), and epididymitis (1 pt G3). There were no rectal injuries. Baseline IPSS of 8 (5-13) recovered to 6 (4-10) at 3 mo (n=29), stable to 8 (5-10) at 18 mo (n=22). The proportion of patients with erections sufficient for penetration remained relatively unchanged from 21/30 (70%) at baseline to 20/29 (69%) at 12 mo and 15/22 (68%) at 18 mo. Median PSA decreased 87% at 1 mo, stable to 0.8 (0.6-1.1) ng/ml at 12 mo (n=30), and to 0.8 (0.4-1.4) ng/ml at 18 mo (n=22). Positive biopsies at 12 mo show 61% reduction in total cancer length, clinically significant disease in 9/29 pts (31%), and any disease in 16/29 pts (55%). CONCLUSIONS We conclude that MRI-TULSA is a safe and well tolerated with a low morbidity profile for a whole-gland prostate ablation. Phase I data are sufficiently compelling to further study MRI-TULSA in a larger trial with reduced safety margins, scheduled to begin in 2016. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e201 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Joseph Chin More articles by this author James Relle More articles by this author Jason Hafron More articles by this author Lonel Popeneciu More articles by this author Timur Kuru More articles by this author Michele Billia More articles by this author Khurram Siddiqui More articles by this author Matthias Roethke More articles by this author Cesare Romagnoli More articles by this author Mathieu Burtnyk More articles by this author Heinz-Peter Schlemmer More articles by this author Sascha Pahernik More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Magnetic Resonance Imaging–Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial

BackgroundMagnetic resonance imaging–guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity. ObjectiveTo determine the clinical safety and feasibility of MRI-TULSA for whole-gland prostate ablation in a primary treatment setting of localized prostate cancer (PCa). Design, setting, and participantsA single-arm prospective phase 1 study was performed at three tertiary referral centers in Canada, Germany, and the United States. Thirty patients (median age: 69 yr; interquartile range [IQR]: 67–71 yr) with biopsy-proven low-risk (80%) and intermediate-risk (20%) PCa were treated and followed for 12 mo. InterventionMRI-TULSA treatment was delivered with the therapeutic intent of conservative whole-gland ablation including 3-mm safety margins and 10% residual viable prostate expected around the capsule. Outcome measurements and statistical analysisPrimary end points were safety (adverse events) and feasibility (technical accuracy and precision of conformal thermal ablation). Exploratory outcomes included quality of life, prostate-specific antigen (PSA), and biopsy at 12 mo. Results and limitationsMedian treatment time was 36min (IQR: 26–44) and prostate volume was 44ml (IQR: 38–48). Spatial control of thermal ablation was ±1.3mm on MRI thermometry. Common Terminology Criteria for Adverse Events included hematuria (43% grade [G] 1; 6.7% G2), urinary tract infections (33% G2), acute urinary retention (10% G1; 17% G2), and epididymitis (3.3% G3). There were no rectal injuries. Median pretreatment International Prostate Symptom Score 8 (IQR: 5–13) returned to 6 (IQR: 4–10) at 3 mo (mean change: −2; 95% confidence interval [CI], −4 to 1). Median pretreatment International Index of Erectile Function 13 (IQR: 6–28) recovered to 13 (IQR: 5–25) at 12 mo (mean change: −1; 95% CI, −5 to 3). Median PSA decreased 87% at 1 mo and was stable at 0.8 ng/ml (IQR: 0.6–1.1) to 12 mo. Positive biopsies showed 61% reduction in total cancer length, clinically significant disease in 9 of 29 patients (31%; 95% CI, 15–51), and any disease in 16 of 29 patients (55%; 95% CI, 36–74). ConclusionsMRI-TULSA was feasible, safe, and technically precise for whole-gland prostate ablation in patients with localized PCa. Phase 1 data are sufficiently compelling to study MRI-TULSA further in a larger prospective trial with reduced safety margins. Patient summaryWe used magnetic resonance imaging–guided transurethral ultrasound to heat and ablate the prostate in men with prostate cancer. We showed that the treatment can be targeted within a narrow range (1mm) and has a well-tolerated side effect profile. A larger study is under way. Trial registrationNCT01686958, DRKS00005311.