Follow-up of vascular-targeted photodynamic therapy in a real-world setting.

PURPOSE: Vascular-targeted photodynamic therapy (VTP) is an approved treatment option for unilateral low-risk prostate cancer (PCa). METHODS: Patients with unilateral low- or intermediate-risk PCa undergoing hemiablation by VTP were evaluated in a real-world setting. Oncological outcome after VTP was measured by MRI-based re-biopsy at 12 and 24 months. Functional outcome after 1 year was investigated by IIEF-5 and IPSS questionnaires. Progression was defined as the evidence3 of ISUP ≥ 2 PCa. RESULTS: At any control biopsy (n = 46) after VTP, only 37% of patients showed no evidence of PCa. Recurrence-free survival was 20 months (95% CI 4.9-45.5) and progression-free survival was 38.5 months (95% CI 33.5-43.6 months). In-field and out-field recurrent PCa occurs in 37% (55% ISUP ≥ 2 PCa) and 35% (56% ISUP ≥ 2 PCa). Seventy-nine percent of patients preserved erectile function, respectively. Ten percent of patients presented long-term bladder outlet obstruction. None of the patients presented incontinence. CONCLUSION: Due to the high-recurrence in- and out-field recurrence rate in a mainly low-risk prostate cancer cohort, VTP has to be regarded critically as a therapy option in these patients. Pre-interventional diagnostic evaluation is the main issue before focal therapy to reduce the risk of tumor recurrence and progression.

Triggers and oncologic outcome of salvage radical prostatectomy, salvage radiotherapy and active surveillance after focal therapy of prostate cancer.

PURPOSE: Due to the tissue preserving approach of focal therapy (FT), local cancer relapse can occur. Uncertainty exists regarding triggers and outcome of salvage strategies. METHODS: Patients with biopsy-proven prostate cancer (PCa) after FT for localized PCa from 2011 to 2020 at eight tertiary referral hospitals in Germany that underwent salvage radical prostatectomy (S-RP), salvage radiotherapy (S-RT) or active surveillance (AS) were reported. Prostate specific antigen (PSA) changes, suspicious lesions on mpMRI and histopathological findings on biopsy were analyzed. A multivariable regression model was created for adverse pathological findings (APF) at S-RP specimen. Kaplan-Meier curves were generated to determine oncological outcomes. RESULTS: A total of 90 men were included. Cancer relapse after FT was detected at a median of 12 months (IQR 9-16). Of 50 men initially under AS 13 received S-RP or S-RT. In total, 44 men underwent S-RP and 13 S-RT. At cancer relapse 17 men (38.6%) in the S-RP group [S-RT n = 4 (30.8%); AS n = 3 (6%)] had ISUP > 2. APF (pT ≥ 3, ISUP ≥ 3, pN + or R1) were observed in 23 men (52.3%). A higher ISUP on biopsy was associated with APF [p = 0.006 (HR 2.32, 97.5% CI 1.35-4.59)] on univariable analysis. Progression-free survival was 80.4% after S-RP and 100% after S-RT at 3 years. Secondary therapy-free survival was 41.7% at 3 years in men undergoing AS. Metastasis-free survival was 80% at 5 years for the whole cohort. CONCLUSION: With early detection of cancer relapse after FT S-RP and S-RT provide sufficient oncologic control at short to intermediate follow-up. After AS, a high secondary-therapy rate was observed.

Do contemporary imaging and biopsy techniques reliably identify unilateral prostate cancer? Implications for hemiablation patient selection.

BACKGROUND: Hemiablation is a less morbid treatment alternative for appropriately selected patients with unilateral prostate cancer (PCa). However, to the authors' knowledge, traditional diagnostic techniques inadequately identify appropriate candidates. In the current study, the authors quantified the accuracy for identifying hemiablation candidates using contemporary diagnostic techniques, including multiparametric magnetic resonance imaging (mpMRI) and MRI-fusion with complete systematic template biopsy. METHODS: A retrospective analysis of patients undergoing MRI and MRI-fusion prostate biopsy, including full systematic template biopsy, prior to radical prostatectomy in a single tertiary academic institution between June 2010 and February 2018 was performed. Hemiablation candidates had unilateral intermediate-risk PCa (Gleason score [GS] of 3+4 or 4+3, clinical T classification ≤T2, and prostate-specific antigen level <20 ng/dL) on MRI-fusion biopsy and 2) no contralateral highly or very highly suspicious Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) MRI lesions. Hemiablation candidates were inappropriately selected if pathologists identified contralateral GS ≥3+4 or high-risk ipsilateral PCa on prostatectomy. The authors tested a range of hemiablation inclusion criteria and performed multivariable analysis of preoperative predictors of undetected contralateral disease. RESULTS: Of 665 patients, 92 met primary hemiablation criteria. Of these 92 patients, 44 (48%) were incorrectly identified due to ipsilateral GS ≥3+4 tumors crossing the midline (21 patients), undetected distinct contralateral GS ≥3+4 tumors (20 patients), and/or ipsilateral high-risk PCa (3 patients) on prostatectomy. The rate of undetected contralateral disease ranged from 41% to 48% depending on inclusion criteria. On multivariable analysis, men with anterior index tumors were found to be 2.4 times more likely to harbor undetected contralateral GS ≥3+4 PCa compared with men with posterior lesions (P < .05). CONCLUSIONS: Clinicians and patients must weigh the risk of inadequate oncologic treatment against the functional benefits of hemiablation. Further investigation into methods for improving patient selection for hemiablation is necessary.

Hemiablation of Localized Prostate Cancer by High-Intensity Focused Ultrasound: A Series of 35 Cases.

Prostate cancer (PrC) is one of the most common tumors diagnosed in men. The detection rate of localized PrC has been dramatically enhanced by screening and the development of visualization methods. There are currently several techniques for focal treatment available, among which the most interesting in our opinion is high-intensity focused ultrasound (HIFU). Currently, HIFU hemiablation of PrC is not an established treatment, although evidence of its effectiveness and safety is growing. We have been performing HIFU hemiablation since 2013 and here report our results to add to the evidence on the effectiveness of the technique. Between October 2013 and December 2016, we performed HIFU hemiablation of the prostate for a total of 35 patients with confirmed PrC stage

Combination of multiparametric magnetic resonance imaging and transrectal ultrasound-guided prostate biopsies is not enough for identifying patients eligible for hemiablative focal therapy for prostate cancer.

PURPOSE: To evaluate focal therapy (hemiablation) eligibility in men undergoing prostate biopsy and multiparametric magnetic resonance imaging (mpMRI) with reference to histopathology from radical prostatectomy (RP) specimens. METHODS: Subjects were selected among 810 men who underwent prostate biopsy, mpMRI, and RP from January 2016 to December 2017. Hemiablation eligibility criteria were biopsy-proven unilateral cancer, prostate-specific antigen ≤ 15 ng/ml, and Gleason score (GS) ≤ 3 + 4. Evidence of non-organ-confined disease or Prostate Imaging Reporting and Data System score ≥ 4 on the contralateral lobe on mpMRI was classified as ineligible for hemiablation. Of the 810, data for 185 who met the screening criteria were compared to final pathology findings. Significant cancer at RP was defined as any of the following: (1) GS 6 with tumor volume ≥ 0.5 ml; (2) GS ≥ 3 + 4; or (3) the presence of advanced stage (≥ pT3). RESULTS: Among the 185 candidates for hemiablation, 62 (33.5%) had unilateral cancer on final RP histopathology. Among the 123 bilateral cancers, 50 (27%) were organ confined and had GS ≤ 3 + 4 = 7 and bilateral multifocal tumor in which the index tumor was confined to one lobe and the secondary tumor in the contralateral lobe had tumor volume < 0.5 ml and GS ≤ 6. A total of 112 (60.5%) patients in this series were considered suitable for hemiablation. Significant cancer on biopsy and mpMRI-negative lobes were found in 72 (38.9%) of 185 lobes, including 1 (0.5%) with advanced stage. CONCLUSIONS: The combination of standard prostate biopsy and mpMRI did not accurately identify lobes that could be considered as non-treated regions.

Salvage Hemiablation High Intensity Focused Ultrasound for unilateral radio-recurrent prostate cancer.

OBJECTIVE: To report the oncological and functional outcomes of salvage hemiablation high-intensity focused ultrasound (HIFU) in patients with unilateral radio-recurrent prostate cancer. PATIENTS AND METHODS: Patients with biochemical recurrence (BCR) after primary radiation therapy and evidence of unilateral organ confined recurrence based on a complete match between mpMRI and MRI targeted biopsies were included. Patients with distant metastasis were excluded. Patients were followed with serial serum PSA determinations. BCR were defined using the Phoenix criteria. Complications were graded according to the Clavien score. IIEF-5 questionnaire was used to assess erectile dysfunction. Urinary incontinence was reported using physician reported rates. RESULTS: A total of 10 consecutive patients (median age: 71 years, IQR: 69-76) were prospectively enrolled. The median pre-treatment PSA and post-treatment PSA nadir were 3.1ng/mL (IQR: 1.54-8.59) and 1.52ng/mL (IQR: 0.76-2.2), respectively. At a median follow-up of 41.5 (IQR: 18-58) months, 50% of patients experience BCR. BCR free-survival rates at 24 and 36 months were 75% (CI95%: 31-93) and 60% (CI95%: 20-85), respectively. Urinary in continence grade II occurred in two patients and the remaining patients were pad-free. One patient developed de novo erectile dysfunction requiring PDE5I. The erectile function scores decreased from a mean of 10.1 to 8.7. CONCLUSION: Hemiablation HIFU is an alternative to whole gland therapy in patients with unilateral radio- recurrent prostate cancer, which offers limited urinary and rectal morbidity, and preserves functional outcomes. LEVEL OF EVIDENCE: 3.

PSA kinetics following primary focal cryotherapy (hemiablation) in organ-confined prostate cancer patients.

PURPOSE: We aim to evaluate prostate-specific antigen (PSA) trends in post-primary focal cryotherapy (PFC) patients. MATERIALS AND METHODS: This was an institutional review board-approved retrospective study of PFC patients from 2010 to 2015. Patients with at least one post-PFC PSA were included in the study. Biochemical recurrence (BCR) was determined using the Phoenix criteria. PSA bounce was also assessed. We analyzed rates of change of PSA over time of post-PFC between BCR and no BCR groups. PSA-derived variables were analyzed as potential predictors of BCR. RESULTS: A total of 104 PFC patients were included in our analysis. Median (range) age and follow-up time were 66 (48-82) years and 19 (6.3-38.6) months, respectively. Four (3.8%) patients experienced PSA bounce. The median percent drop in first post-PFC PSA of 80.0% was not associated with BCR (p = 0.256) and may indicate elimination of the index lesion. The rate of increase of PSA in BCR patients was significantly higher compared to patients who did not recur (median PSA velocity (PSAV): 0.15 vs 0.04 ng/ml/month, p = 0.001). Similar to PSAV (HR 9.570, 95% CI 3.725-24.592, p < 0.0001), PSA nadir ≥ 2 ng/ml [HR (hazard ratio) 1.251, 95% CI 1.100-1.422, p = 0.001] was independently associated with BCR. CONCLUSION: A significant drop in post-PFC PSA may indicate elimination of the index lesion. Patients who are likely to recur biochemically have a significantly higher PSAV compared to those who do not recur. Nadir PSA of less than 2 ng/ml may be considered the new normal PSA in focal cryotherapy (hemiablation) follow-up.

Combination of multiparametric magnetic resonance imaging and transperineal template-guided mapping prostate biopsy to determine potential candidates for focal therapy.

Background: We assessed the ability of the combination of multiparametric magnetic resonance imaging (mpMRI) and transperineal template-guided mapping biopsy (TTMB) to determine the eligibility for focal therapy (FT) (hemiablation) in men and compared it with that of histology from radical prostatectomy (RP) specimens. Materials and methods: In this study, 120 men who underwent mpMRI, TTMB, and RP in a single tertiary center from May 2017 to June 2021 were analyzed. The criteria of hemiablation eligibility were unilateral low-to intermediate-risk prostate cancer (limited to a maximum of International Society of Urological Pathology (ISUP) grade group 3 and prostate-specific antigen (PSA) <20 ng/mL) and clinical stage ≤T2. Evidence of non-organ-confined disease or contralateral Prostate Imaging Reporting and Data System (PI-RADS) v2 score ≥4 on mpMRI was classified as ineligible for hemiablation. Clinically significant cancer at RP was defined as any of the following: (1) ISUP grade group 1 with tumor volume ≥1.3 mL; (2) ISUP grade group ≥2; or (3) the presence of advanced stage (≥pT3). Results: Of the 120 men, data of 52 men who met the selection criteria for hemiablation were compared with final RP findings. Of these 52 men, 42 (80.7%) could be considered suitable for hemiablation on RP. The sensitivity, specificity, and accuracy of mpMRI and TTMB in predicting FT eligibility were 80.7%, 85.1%, and 82.5%, respectively. The rate of undetected contralateral significant cancer was 10 (19.2%) on mpMRI and TTMB. Six had bilateral significant cancer and four had small volumes of ISUP grade group ≥2. Conclusions: The combination of mpMRI and TTMB substantially improves the prediction of potential candidates for hemiablation based on consensus recommendations. Improved selection criteria and further investigative tools are required to improve patient selection for hemiablation.

High-intensity focused ultrasound (HIFU) hemiablation of the prostate: Late follow-up MRI findings in non-recurrent patients.

OBJECTIVES: Focal therapy with high-intensity focused ultrasound (HIFU) is an emerging option for the treatment of prostate cancer and often followed up by MRI. Image assessment of treatment failure, however, requires proper knowledge about typical procedure-related changes in prostate MRI, which is sparse, in particular for unilateral HIFU treatment and late follow up (beyond 6 months). The goal of this study was therefore to compile the type and frequency of such MRI findings in selected patients without recurrent cancer 12 months after prostate hemiablation. METHODS: Data from a prospective multicenter trial on HIFU hemiablation were reviewed retrospectively. Trial patients have had a late follow-up by MRI (at around 12 months) and either MRI/transrectal ultrasound (TRUS) fusion or standard TRUS-guided biopsy. This work deliberately included patients with non-recurrent cancer in the treated prostate lobe in per-protocol biopsy leaving 30 men with initial International Society of Urological Pathology (ISUP) Grade Group of 1 or 2. Six categories of potential HIFU-related MRI features were assessed by an expert committee and then evaluated by two readers in consensus: 1. shrinkage of the treated lobe, 2. residual prostate tissue, 3. fluid-filled cavity, 4. fibrosis, 5. hematoma residuals (in the prostate or seminal vesicles) and 6. contrast enhancement of the ablated area. RESULTS: Shrinkage of the ablated lobe was seen in 93% of the cases with an average percent volume change of -37% (range: -70% to +108%). In the contralateral lobe, the volume remained practically the same (-2% on average, p = 0.804). In the ablated lobe, the frequency of fibrosis was 97%. Residual prostate tissue was seen in 93% of the cases. The frequency for fluid-filled cavities was 97%, with the wide majority (90%) contiguous with the urethra. Hematoma residuals in the prostate and in seminal vesicles were found in 47% and 10% of the patients, respectively. Contrast enhancement was both rim-like (50%) as well as diffuse (33%) within the ablated area. CONCLUSION: In our case series of HIFU hemiablation in the prostate, shrinkage, residual prostate tissue, fluid-filled cavities contiguous with the urethra and fibrosis were very common late MRI findings of the ablated lobe in non-recurrent patients. Rim-like contrast enhancement or diffuse one within the ablated area were less frequent.

Potential Candidates for Focal Therapy in Prostate Cancer in the Era of Magnetic Resonance Imaging-targeted Biopsy: A Large Multicenter Cohort Study.

BACKGROUND: Focal therapy (FT) with its favorable side-effect profile represents an option between active surveillance and traditional whole-gland treatment in localized prostate cancer (PCa). Consensus statements recommend eligibility criteria based on magnetic resonance imaging (MRI)-targeted and systematic combination biopsy. OBJECTIVE: To estimate the future potential of FT by analyzing the number of men eligible for FT among all men with biopsy-proven PCa and to judge the potential of different energy sources. DESIGN, SETTING, AND PARTICIPANTS: Consensus criteria on FT were analyzed. Patients with biopsy-proven PCa from six tertiary referral hospitals and one outpatient practice in Germany had received a software-based combination biopsy. Men with Prostate Imaging Reporting and Data System (PI-RADS) ≥3 lesions based on PI-RADS v2 were included. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were analyzed for potential treatment by FT and hemiablation. MRI lesions were mapped according to prostatic zones. RESULTS AND LIMITATIONS: In total, 2371 patients were analyzed. According to consensus criteria (biopsy-proven unifocal lesion of International Society of Urological Pathology [ISUP] grade group ≤2, prostate-specific antigen [PSA] ≤15ng/mL, and life expectancy >10yr), 303 patients (12.8%; ISUP 1: n=148 [6.2%]; ISUP 2: n=155 [6.5%]) were potential candidates for FT. A maximum PSA level of <10ng/mL would exclude further 60 (2.5%) of these men. The eligibility for hemiablation is slightly higher (16.2%). Unifocal lesions (n=288) were equally distributed within the prostate (anteriorly [31%], apically [29%], and dorsally [36%]). CONCLUSIONS: With adherence to consensus statements, only a minority of PCa patients present as potential candidates for FT. Distribution of tumor localization suggests the need for different energy modalities to warrant an optimal FT treatment. PATIENT SUMMARY: We analyzed how many men who receive a magnetic resonance imaging-targeted and systematic prostate biopsy are candidates for the experimental focal therapy of the prostate. When following expert recommendations, only a small number of men are potential candidates for this alternative treatment.

Histological characteristics of the largest and secondary tumors in radical prostatectomy specimens and implications for focal therapy.

BACKGROUND: Pathological features of prostate cancer in Korean men were analyzed to determine whether identification of tumor volume, Gleason score (GS), focality, and location using radical prostatectomy (RP) specimens can provide useful information for the application of focal therapy (hemiablation). METHODS: From January 2016 to December 2017, 913 patients who underwent RP at a single center were selected for analysis. Patients with prostate-specific antigen levels > 15 ng/mL or those who had received hormone therapy prior to surgery were excluded. Preoperative data and the number, volume, location, and GS of each tumor were recorded. RESULTS: Overall, 762 RP specimens were examined, and 1448 tumors were identified. The majority of the cases were multifocal (60.5%) and bilateral (82%) in nature. Among the 686 secondary tumors, 250 (36.4%) had a GS ≥7 and 122 (17.8%) had a tumor volume ≥ 0.5 mL. Among the 435 bilateral multifocal cases, secondary tumors on the lobes contralateral to the largest tumor were significant by volume (≥0.5 mL) in 91 (20.9%) cases and by grade (GS ≥7) in 179 (41.1%) cases. There were 102 (23.4%) tumors with a small tumor volume (< 0.5 mL) and Gleason pattern 4 on the lobe contralateral to the largest tumor. CONCLUSIONS: Bilateral and multifocal tumors are a common feature and secondary tumors frequently exhibit clinically significant prostate cancer on RP specimens in Korea. In many cases, secondary tumors on the lobe contralateral to the largest tumor had a high GS and small tumor volume.

Focal Treatment for Unilateral Prostate Cancer Using High-Intensity Focal Ultrasound: A Comprehensive Study of Pooled Data.

BACKGROUND: Focal therapy for prostate cancer (PCa) remains experimental. Aim of the current study is to review available evidence and perform a pooled analysis exploring oncologic and functional results of high intensity focus ultrasound (HIFU) focal therapy for the treatment of unilateral PCa. METHODS: The National Library of Medicine Database was searched for relevant articles. A wide search was performed, including the combination of following words: "HIFU," "prostate," "cancer," and "focal." Overall, 167 articles were reviewed. Of these, seven articles were identified and eligible for the pooled analysis. Data on HIFU hemiablation or focal prostate ablation, oncologic and functional results were pooled from these seven studies that included 366 men with unilateral PCa. RESULTS: In the 366 analyzed cases, mean age was 67 years (95% confidence interval 66-69), and mean preoperative prostate-specific antigen was 6.4 ng/cc (5.5-7.4). Three studies included PCa up to Gleason 7 (3 + 4), three studies did include also Gleason 7 (4 + 3), whereas one study had no limitation in terms of Gleason score. Regarding early complications, low-grade Clavien-Dindo I-II were reported in 26% (16-37), whereas high-grade Clavien-Dindo ≥III were found in 3.8% (0-8.6). Analyzing oncologic outcomes mean follow-up was 26 months (23-31): at one year after HIFU, negative biopsy rate for clinically significant PCa was 87% (79-96), whereas salvage treatment-free survival rate was 92% (85-98). Regarding functional outcomes, reported potency rates were 74% (64-84), and continence 96% (91-100), although definitions of potency and continence were not homogenous across studies. CONCLUSIONS: This pooled analysis of the results of focal HIFU treatment of PCa shows promising oncologic and functional outcomes. Well-selected patients may be candidates for such a conservative partial treatment of the gland. Well-designed trials are awaited to compare HIFU focal treatment with current standard of care.

Focal High Intensity Focused Ultrasound of Unilateral Localized Prostate Cancer: A Prospective Multicentric Hemiablation Study of 111 Patients.

BACKGROUND: Up to a third of patients with localized prostate cancer have unilateral disease that may be suitable for partial treatment with hemiablation. OBJECTIVE: To evaluate the ability of high intensity focused ultrasound (HIFU) to achieve local control of the tumor in patients with unilateral localized prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: The French Urological Association initiated a prospective IDEAL multi-institutional study (2009-2015), to evaluate HIFU-hemiablation as a primary treatment. INTERVENTION: Multiparametric magnetic resonance imaging and biopsy were used for unilateral cancer diagnosis and control, and HIFU-hemiablation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary: absence of clinically significant cancer (CSC) on control biopsy at 1 yr (CSC: Gleason score ≥ 7 or cancer core length>3mm regardless of grade or > 2 positive cores). Secondary: presence of any cancer on biopsy, biochemical response, radical treatment free survival, adverse events, continence (no pad), erectile function (International Index of Erectile Function-5 ≥ 16), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C28) questionnaires. RESULTS AND LIMITATIONS: One hundred and eleven patients were treated (mean age: 64.8 yr [standard deviation 6.2]; mean prostate-specific antigen: 6.2 ng/ml [standard deviation 2.6]; 68% low risk, 32% intermediate risk). Of the 101 patients with control biopsy, 96 (95%) and 94 (93%) had no CSC in the treated and contralateral lobes, respectively. Mean prostate-specific antigen at 2 yr was 2.3 ng/ml (standard deviation 1.7). The radical treatment-free survival rate at 2 years was 89% (radical treatments: six radical prostatectomies, three radiotherapies, and two HIFU). Adverse events were Grade 3 in 13%. At 12 mo continence and erectile functions were preserved in 97% and 78%. No significant decrease in quality of life score was observed at 12 mo. One limitation is the number of low-risk patients included in this study. CONCLUSIONS: At 1 yr, HIFU-hemiablation was efficient with 95% absence of clinically significant cancer associated with low morbidity and preservation of quality of life. Radical treatment-free survival rate was 89% at 2 yr. PATIENT SUMMARY: This report shows that high intensity focused ultrasound half-gland treatment of unilateral prostate cancer provides promising results with high cancer control and low morbidity.

Clinical validation of real-time tissue change monitoring during prostate tissue ablation with high intensity focused ultrasound.

BACKGROUND: The purpose of these clinical studies was to validate a Tissue Change Monitoring (TCM) algorithm in vivo. TCM is a quantitative tool for the real-time assessment of HIFU dose. TCM provides quantitative analysis of the backscatter pulse echo signals (pre and immediately post HIFU) for each individual ablative site, using ultrasonic tissue characterization as a surrogate for monitoring tissue temperature. Real-time analysis generates an energy difference parameter (ΔE in dB) that is proportional to tissue temperature. METHODS: Post in vitro studies, two clinical studies were conducted to validate the TCM algorithm on the Sonablate® device. Studies enrolled histologically confirmed, organ confined prostate cancer patients. The first clinical study was conducted in two phases for whole gland ablation. First eight patients' data were used to measure the algorithm performance followed by 89 additional patients for long term outcome. The second clinical study enrolled five patients; four patients with focal cancer had hemi-ablation only and one had whole gland ablation. Four 3 Fr. needles containing three thermocouples each were placed transperineally in the prostate to record tissue temperatures in the focal zone, posterior to the focal zone and on the lateral gland where no HIFU was applied. Tissue temperatures from the focal zone were correlated to the ΔE parameter. RESULTS: In the first clinical study, the average TCM rate was 86%. Pre and 6 months post HIFU, median PSA was 7.64 and 0.025 ng/ml respectively and 97% patients had negative biopsy. For the second clinical study, the measured prostate tissue temperatures (Average, Max, and Min) in the ablation zones were 84°, 114° and 60 °C and the corresponding ΔE (dB/10) parameters were 1.05, 2.6 and 0.4 resulting in 83% of temperatures in the range of 75°-100 °C and 17% in the 60°-74 °C range. Outside the focal zone, the average temperature was 50 °C and in the lateral lobe where no HIFU was applied, peak temperature was 40.7 °C. CONCLUSIONS: The TCM algorithm is able to estimate tissue changes reliably during the HIFU procedure for prostate tissue ablation in real-time and can be used as a guide for HIFU dose delivery and tissue ablation control.

Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes.

BACKGROUND: In selected patients with unilateral, organ-confined prostate cancer (PCa), hemiablation of the affected lobe might be feasible to achieve acceptable cancer control with fewer complications. OBJECTIVES: To assess the oncologic and functional outcomes of focal high-intensity focused ultrasound (HIFU) hemiablation in unilateral organ-confined PCa. DESIGN, SETTING AND PATIENTS: Single-center prospective evaluation of HIFU hemiablation for unilateral organ-confined PCa was performed from July 2009 through December 2013. INTERVENTION: Cancer localization was done with transrectal ultrasound-guided biopsy and multiparametric magnetic resonance imaging followed by HIFU hemiablation. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Oncologic outcomes were analyzed with control biopsies and prostate-specific antigen (PSA) measurement. Functional outcomes were assessed with validated questionnaires for genitourinary symptoms. RESULTS AND LIMITATIONS: Of 71 HIFU hemiablation patients, 67 completed the study protocol. The mean age was 70.2 yr (standard deviation: 6.8 yr), and median PSA was 6.1 ng/ml (interquartile range [IQR]: 1.6-15.5 ng/ml). Median maximum cancer-core length was 3 mm (IQR: 2-10 mm), and total cancer length was 6.5 mm (IQR: 2-24 mm). Gleason score was 6 (3+3) in 58 patients (86.6%) and 7 (3+4) in 9 patients (13.4%). Median follow-up was 12 mo (IQR: 6-50 mo), and at 12 mo, 56 of 67 patients had a negative control biopsy in the treated lobe. At 3 mo, all patients were continent, and potency was maintained in 11 of 21 preoperatively potent patients (confidence interval, 0.18-0.69). Complications included 8% Clavien-Dindo grade 2 and 2.8% grade 3 events. CONCLUSIONS: Focal HIFU hemiablation appears to achieve acceptable oncologic outcomes with low morbidity and minimal functional changes. Longer follow-up will establish future considerations. PATIENT SUMMARY: This study showed that high-intensity focused ultrasound hemiablation in selected patients with unilateral organ-confined prostate cancer can be used for satisfactory cancer control with minimal effect on genitourinary functions.

High intensity focused ultrasound with Focal-One® device: Prostate-specific antigen impact and morbidity evaluation during the initial experience. / Ultrasonido focalizado de alta intensidad con el dispositivo Focal-One®: impacto sobre el antígeno prostático específico y evaluación de la morbilidad durante la experiencia inicial.

OBJECTIVE: We report our initial experience in the treatment of prostate cancer (PCa) with high-intensity focused ultrasound (HIFU) using the Focal-One® device. MATERIAL AND METHODS: Retrospective review of the prospectively populated database. Between June 2014 to October 2015, 85 patients underwent HIFU (focal/whole-gland) treatment for localized PCa. Preoperative cancer localization was done with multiparametric magnetic resonance imaging (mpMRI) and transperineal mapping biopsies. Treatment was carried out using the Focal-One® device under general anesthesia. Oncological follow-up: PSA measurement and control biopsy with mpMRI according to protocol. Questionnaire-based functional outcome assessment was done. Complications were reported using Clavien classification. RESULTS: The median PSA was 7.79ng/ml (IQR 6.32-9.16), with a median prostate volume of 38cc (IQR: 33-49.75). Focal and whole-gland therapy was performed in 64 and 21 patients respectively. Ten patients received salvage HIFU. Complications were encountered in 15% of cases, all Clavien 2 graded. Mean hospital stay was 1.8 days (0-7) and bladder catheter was removed on day 2 (1-6). Mean percentage reduction of PSA was 54%. Median follow-up was 3 months (IQR: 2-8). Functional outcomes: All patients were continents at 3 months and potency was maintained in 83% of the preoperatively potent. CONCLUSIONS: Focal-One® HIFU treatment appears to be a safe procedure with few complications. Functional outcomes proved no urinary incontinence and sexual function were maintained in 83%.