Transperineal Laser Ablation for Focal Therapy of Localized Prostate Cancer: 12-Month Follow-up Outcomes from a Single Prospective Cohort Study.

INTRODUCTION AND OBJECTIVES: To evaluate the oncological and functional outcomes of transperineal laser ablation (TPLA) as the focal therapy for localized prostate cancer (PCa) after a 12-month follow-up. MATERIALS AND METHODS: Patients with low- and intermediate-risk localized PCa were prospectively treated with focal TPLA between July 2021 and December 2022. The inclusion criteria were the following: clinical stage < T2b; PSA < 20 ng/mL; International Society of Urological Pathology (ISUP) grade ≤ 2; MRI-fusion biopsy-confirmed lesion classified as PI-RADS v2.1 ≥ 3. Intra-, peri-, and post-operative data were collected. Variables including age, PSA, prostate volume (PVol), Charlson's Comorbidity Index (CCI), International Prostate Symptom Score (IPSS) with QoL score, International Index of Erectile Function (IIEF-5), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD) were collected at baseline and at 3, 6 and 12 months after TPLA. Post-operative mpMRI was performed at 3 and 12 months. Finally, all patients underwent prostatic re-biopsy under fusion guidance at 12 months. The success of this technique was defined as no recurrence in the target treated lesion at the 12-month follow up. RESULTS: Twenty-four patients underwent focal TPLA. Baseline features were age [median 67 years (IQR 12)], PSA [5.7 ng/mL (3.9)], PVol [49 mL (27)], CCI [0 (0)], IPSS [11 (9)], IPSS-QoL [2 (2)], IIEF-5 [21 (6)], ICIQ-SF [0 (7)], MSHQ-EjD ejaculation domain [14 (4)] and bother score [0 (2)]. Median operative time was 34 min (IQR 12). Median visual analogue scale (VAS) 6 h after TPLA was 0 (IQR 1). The post-operative course was regular for all patients, who were discharged on the second post-operative day and underwent catheter removal on the seventh post-operative day. No patient had incontinence at catheter removal. A significant reduction in PSA (p = 0.01) and an improvement in IPSS (p = 0.009), IPSS-QoL (p = 0.02) and ICIQ-SF scores (p = 0.04) compared to baseline were observed at the 3-month follow-up. Erectile and ejaculatory functions did not show any significant variation during the follow-up. No intra- and peri-operative complications were recorded. Three Clavien-Dindo post-operative complications were recorded (12%): grade 1 (two cases of urinary retention) and grade 2 (one case of urinary tract infection). At the 12-month follow-up, eight patients showed mpMRI images referable to suspicious recurrent disease (PIRADS v2.1 ≥ 3). After re-biopsy, 7/24 patients' (29%) results were histologically confirmed as PCa, 3 of which were recurrences in the treated lesion (12.5%). The success rate was 87.5%. CONCLUSIONS: The focal TPLA oncological and functional results seemed to be encouraging. TPLA is a safe, painless, and effective technique with a good preservation of continence and sexual outcomes. Recurrence rate at 12 months was about 12.5%.

Transperineal Laser Ablation (TPLA) Treatment of Focal Low-Intermediate Risk Prostate Cancer.

Background: This interventional pilot study aimed to evaluate the short-term (3 years) efficacy of focal laser ablation (FLA) in treating the index lesion of low-intermediate-risk prostate cancer, along with assessing the safety of the procedure (ClinicalTrials.gov ID NCT04045756). Methods: Forty patients aged between 46 and 86 with histologically proven organ-confined prostate cancer and low-to-intermediate progression risk were included. FLA was performed under percutaneous fusion magnetic resonance/ultrasound guidance in a Day Hospital setting under local anesthesia. Patients underwent regular clinical and functional assessments through the international index of erectile function (IIEF-5) and the International Prostatism Symptom Score (IPSS), PSA measurements, post-procedure MRI scans, and biopsies at 36 months or if positive findings were detected earlier. Statistical analyses were conducted to assess trends in PSA levels and cavity dimensions over time. Results: Forty patients were initially included, with fifteen lost to follow-up. At 36 months, a mean PSA reduction of 60% was observed, and 80% of MRI scans showed no signs of in-field clinically significant residual/recurrent cancer. Biopsies at 36 months revealed no malignant findings in 20 patients. No deterioration in sexual function or urinary symptoms was recorded. Conclusions: FLA appears to be safe, feasible, and effective in the index lesion treatment of low-intermediate-risk prostate cancer, with a high rate of tumor eradication and preservation of quality of life.

Transperineal laser ablation as a new minimally invasive surgical therapy for benign prostatic hyperplasia: a systematic review of existing literature.

Introduction: Transperineal laser ablation (TPLA) of the prostate is a new, minimally invasive technique for benign prostatic hyperplasia (BPH) with promising effectiveness and safety outcomes. This systematic review aims to provide an update of existing literature. Methods: A literature review was performed in Pubmed/MEDLINE, Embase, Cochrane Library, and clinicaltrials.gov from January 2000 up to April 2023. Data extraction and risk of bias were performed independently by three authors. Results: A total of 11 studies were included, among which 9 were observational, 1 randomized controlled trial, 1 animal study, while 2 of them were comparative (1 with prostatic artery embolization and 1 with transurethral resection of the prostate). Functional outcomes were improved in the majority of studies both for objective (maximum flow rate and post-void residual) and subjective outcomes (improvement of International Prostate Symptom Score and quality of life). Complication rates ranged between 1.9% and 2.3% for hematuria, 3.7% and 36.3% for dysuria, 1.9% and 19% for acute urinary retention, 0.6% and 9.1% for orchitis/urinary tract infections, and 0.6% and 4.8% for prostatic abscess formation. Regarding sexual function, >95% of patients retained their ejaculation while erectile function was maintained or improved. Conclusion: TPLA of the prostate is an innovative, minimally invasive technique for managing patients with BPH. Existing studies indicate an effective technique in reducing International Prostate Symptom Score and quality of life scores, post-void residual reduction, and increase in Qmax, albeit the measured improvements in terms of Qmax are not equal to transurethral resection of the prostate. Although sexual function is maintained, the mean catheterization time is 7 days, and no long-term data are available for most patients.

Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial.

OBJECTIVES: To evaluate the reliability of transperineal interstitial laser ablation of the prostate (TPLA) in preserving antegrade ejaculation compared to transurethral resection of the prostate (TURP). PATIENTS AND METHODS: In this single-centre, prospective, randomized, open-label study, consecutive patients with indication for surgical treatment for benign prostatic obstruction (BPO) were enrolled between January 2020 and September 2021 (NCT04781049). Patients were randomized to one of two treatment arms: Group A: TPLA (experimental group) and Group B: TURP (reference standard group). The primary endpoint was change in ejaculatory function (assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain [EJ-MSHQ]) at 1 month after surgery. Secondary endpoints included comparison of visual analogue scale (VAS) scores, changes in sexual function (assessed using the five-item International Index of Erectile Function [IIEF-5]), change in International Prostate Symptom Score [IPSS], change in quality of life score, and maximum urinary flow rate [Qmax ] improvement at 1-6 months, as appropriate. RESULTS: Fifty-one patients (26 TPLA vs 25 TURP) were analysed. No differences in the perception of pain assessed by VAS and no differences in IIEF-5 score were found between the groups. The distribution of ejaculatory function assessed by the EJ-MSHQ remained unmodified after TPLA (P = 0.2), while a median 30% decrease in EJ-MSHQ score was observed after TURP (P = 0.01). Absence of antegrade ejaculation was reported in one patient in the TPLA group (vs 18 patients in the TURP group). A statistically significant difference between the treatment groups was found in terms of postoperative Qmax (TPLA vs TURP: 15.2 [interquartile range 13.5-18.3] mL/s vs 26.0 [interquartile range 22.0-48.0] mL/s; P < 0.001). Both treatments significantly improved Qmax , with a mean 23.9 mL/s improvement after TURP (95% confidence interval [CI] 17.1-30.7) vs 6.0 mL/s after TPLA (95% CI 5.0-7.0), and IPSS, with a mean decrease of 11.6 (95% CI 9.7-13.5) vs 5.8 after TPLA (95% CI.2-9.6) with respect to baseline. CONCLUSION: In our study, TPLA preserved ejaculatory function in 96% of cases in addition to providing significant relief from BPO.

Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction.

We aimed to review the current evidence on surgical and functional outcomes of Transperineal Laser Ablation for LUTS due to BPH. A comprehensive review of the English-language literature was performed using the MEDLINE and Web of Science databases until 1 August 2022, aiming to select studies evaluating TPLA for the treatment of LUTS due to BPH. Additional records were found from Google Scholar. Data were extracted and summarized in Tables. An appropriate form was used for qualitative data synthesis. Seven studies were included in the review, with all being single arm, non-comparative studies. In all studies, functional outcomes were evaluated with uroflowmetry parameters and validated questionnaires, showing a promising effectiveness at short- and mid-term follow-up. There is a lack of standardized pathways for preoperative assessment of patients suitable for TPLA, and even the technique itself has been reported with a few nuances. A good safety profile has been reported by all the authors. Although promising results have been reported by different groups, selection criteria for TPLA and few technical nuances regarding the procedure were found to be heterogeneous across the published series that should be standardized in the future. Further research is needed to confirm these findings.

Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperplasia: a single institutional experience.

PURPOSE: To evaluate the feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation (TPLA) as a new minimally invasive surgical therapy (MIST) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Under local anesthesia and conscious sedation up to two laser fibers for each prostatic lobe were inserted under US-guidance by a percutaneous approach. TPLA was performed using a continuous wave diode laser (SoracteLite-EchoLaserX4) able to generate a light-induced thermal heating and subsequent coagulative necrosis of the prostatic tissue. Patients were evaluated at 3, 6, and 12 months after TPLA. RESULTS: Twenty-two consecutive patients were prospectively enrolled (median age 61.9 years). All procedures were well tolerated and no procedural complications were recorded. Median catheterization time was 7 days, while the median hospitalization time was 1 day. Three out of twenty-two patients (13.6%) experienced acute urinary retention and two (9.1%) of them urinary tract infection requiring major antibiotic treatment. At 3, 6, and 12 months, median prostate volume significantly decreased by a - 21.3%, - 29%, and - 41%, respectively. At the same time point, median IPSS was 8 (- 63.6%), 5 (- 74%), and 6 (- 75%), while median QoL score was 1 in all the scheduled timepoints of follow-up. The median postoperative Qmax at 3, 6, and 12 months improved by + 57.8%, + 98%, and + 115.8%, respectively. Ejaculatory function was preserved in 21 out of 22 patients (95.5%). CONCLUSIONS: TPLA of the prostate appears to be a promising MIST for BPH. Long-term results and comparative studies against standard treatments are warranted before implementations of this technique in the urologist's armamentarium.

Developing a 3D composite training model for cranial remodeling.

OBJECTIVE: Craniosynostosis correction, including cranial vault remodeling, fronto-orbital advancement (FOA), and endoscopic suturectomy, requires practical experience with complex anatomy and tools. The infrequent exposure to complex neurosurgical procedures such as these during residency limits extraoperative training. Lack of cadaveric teaching tools given the pediatric nature of synostosis compounds this challenge. The authors sought to create lifelike 3D printed models based on actual cases of craniosynostosis in infants and incorporate them into a practical course for endoscopic and open correction. The authors hypothesized that this training tool would increase extraoperative facility and familiarity with cranial vault reconstruction to better prepare surgeons for in vivo procedures. METHODS: The authors utilized representative craniosynostosis patient scans to create 3D printed models of the calvaria, soft tissues, and cranial contents. Two annual courses implementing these models were held, and surveys were completed by participants (n = 18, 5 attending physicians, 4 fellows, 9 residents) on the day of the course. These participants were surveyed during the course and 1 year later to assess the impact of this training tool. A comparable cohort of trainees who did not participate in the course (n = 11) was also surveyed at the time of the 1-year follow-up to assess their preparation and confidence with performing craniosynostosis surgeries. RESULTS: An iterative process using multiple materials and the various printing parameters was used to create representative models. Participants performed all major surgical steps, and we quantified the fidelity and utility of the model through surveys. All attendees reported that the model was a valuable training tool for open reconstruction (n = 18/18 [100%]) and endoscopic suturectomy (n = 17/18 [94%]). In the first year, 83% of course participants (n = 14/17) agreed or strongly agreed that the skin and bone materials were realistic and appropriately detailed; the second year, 100% (n = 16/16) agreed or strongly agreed that the skin material was realistic and appropriately detailed, and 88% (n = 14/16) agreed or strongly agreed that the bone material was realistic and appropriately detailed. All participants responded that they would use the models for their own personal training and the training of residents and fellows in their programs. CONCLUSIONS: The authors have developed realistic 3D printed models of craniosynostosis including soft tissues that allow for surgical practice simulation. The use of these models in surgical simulation provides a level of preparedness that exceeds what currently exists through traditional resident training experience. Employing practical modules using such models as part of a standardized resident curriculum is a logical evolution in neurosurgical education and training.

Strategy for performing treponemal tests in reverse-sequence algorithms of syphilis diagnosis.

OBJECTIVES: In South Korea, automated T. pallidum Latex Agglutination (TPLA) based on turbidoimmunoassays and immunochromatographic assay (ICA) are widely used for syphilis diagnosis. However, there is sparse data on the validation of these assays in the reverse-sequence algorithm setting. METHODS: We assessed 551 specimens submitted for syphilis testing. We compared varying reverse-sequence algorithms using combinations of the Cobas Syphilis EIA (Roche Diagnostics, Mannheim, Germany), Mediace TPLA (Sekisui Medical Co., Tokyo, Japan), TPPA (Fujirebio Inc., Tokyo, Japan), and SD Bioline ICA (Standard Diagnostic, Yongin, Korea). We also evaluated modified algorithms incorporating a cut off of high specificity for EIA and TPLA using receiver operating characteristic curves. RESULTS: The agreement was almost perfect between EIA and TPLA (Kappa, 0.953) and strong between TPPA and ICA (Kappa, 0.887). Among TPPA positive and ICA negative specimens, 67% of the specimens were from individuals with syphilis histories. Compared to EIA/RPR/TPPA, the agreement with EIA/RPR/ICA, TPLA/RPR/TPPA and TPLA/RPR/ICA were almost perfect (Kappa, 0.930, 0.995 and 0.914, respectively). When a cut off of 95% specificity was applied, the number of TPPA tests could be reduced by 44% and 40% in EIA and TPLA, respectively. CONCLUSIONS: TPLA showed almost perfect agreement with EIA and that it could be used in the site of EIA in a reverse sequence algorithm. ICA showed a lower detection rate than TPPA as a 2nd treponemal test and should be used with caution. With cut offs of higher specificity, more efficient reverse-sequence algorithms can be made possible.

Comparison of automated treponemal and nontreponemal test algorithms as first-line syphilis screening assays.

BACKGROUND: Automated Mediace Treponema pallidum latex agglutination (TPLA) and Mediace rapid plasma reagin (RPR) assays are used by many laboratories for syphilis diagnosis. This study compared the results of the traditional syphilis screening algorithm and a reverse algorithm using automated Mediace RPR or Mediace TPLA as first-line screening assays in subjects undergoing a health checkup. METHODS: Samples from 24,681 persons were included in this study. We routinely performed Mediace RPR and Mediace TPLA simultaneously. Results were analyzed according to both the traditional algorithm and reverse algorithm. Samples with discordant results on the reverse algorithm (e.g., positive Mediace TPLA, negative Mediace RPR) were tested with Treponema pallidum particle agglutination (TPPA). RESULTS: Among the 24,681 samples, 30 (0.1%) were found positive by traditional screening, and 190 (0.8%) by reverse screening. The identified syphilis rate and overall false-positive rate according to the traditional algorithm were lower than those according to the reverse algorithm (0.07% and 0.05% vs. 0.64% and 0.13%, respectively). A total of 173 discordant samples were tested with TPPA by using the reverse algorithm, of which 140 (80.9%) were TPPA positive. CONCLUSIONS: Despite the increased false-positive results in populations with a low prevalence of syphilis, the reverse algorithm detected 140 samples with treponemal antibody that went undetected by the traditional algorithm. The reverse algorithm using Mediace TPLA as a screening test is more sensitive for the detection of syphilis.