Suprapubic Transvesical Adenoma Resection of the Prostate (STAR-P): A Novel Technique for Surgical Treatment of Benign Prostatic Hyperplasia.

BACKGROUND AND OBJECTIVE: Several minimally invasive treatments have been developed to treat benign prostatic obstruction (BPO) via a transurethral approach, with a non-negligible risk of complications such as urethral stricture and external sphincter damage. Our aim was to present the Gozzi surgical technique for suprapubic transvesical adenoma resection of the prostate (STAR-P) for BPO and to assess its safety, feasibility, and outcomes. METHODS: We conducted a retrospective analysis of 44 consecutive patients who underwent STAR-P for BPO. All the procedures were performed in a single private hospital by one surgeon from 2020 to 2022. An innovative resectoscope designed by the surgeon was subsequently produced by Tontarra Medizintechnik (Wurmlingen, Germany) with a 42.06 Fr external sheath that allows the use of loops of three different sizes. The instrument is inserted into the bladder via suprapubic access, which ensures greater freedom of movement without compromising the external sphincter. Clinical data were retrospectively collected. Preoperative and intraoperative variables, postoperative complications, and functional outcomes of the STAR-P procedure were assessed. A descriptive statistical analysis was performed. KEY FINDINGS AND LIMITATIONS: No intraoperative complications were observed. Two patients (4.5%) experienced urinary urgency symptoms after catheter removal that resolved within 90 d. Median times were 105 min for surgery overall and 65 min for resection. All patients showed an improvement in voiding quality. CONCLUSIONS AND CLINICAL IMPLICATIONS: STAR-P is a safe, feasible, and cost-effective procedure that spares the bulbomembranous and penile urethra and the external urethral sphincter, and should be discussed with patients as a possible option for treatment of BPO. PATIENT SUMMARY: We describe a new, safe, and feasible technique for surgical treatment of urinary obstruction caused by a large prostate. Keyhole surgery is performed through the lower abdomen, which means that the urethra below the prostate is not damaged. Only a small scar of 2-3 cm in the lower abdomen is evident at the end of the healing process.

ONE SHOT - single shot radiotherapy for localized prostate cancer: 18-month results of a single arm, multicenter phase I/II trial.

PURPOSE: To assess in a prospective, multicenter, single-arm phase I/II study the early safety and efficacy profile of single fraction urethra-sparing stereotactic body radiotherapy (SBRT) for men with localized prostate cancer. MATERIAL AND METHODS: Patients with low- and intermediate-risk localized prostate cancer without significant tumor in the transitional zone were recruited. A single-fraction of 19 Gy was delivered to the prostate, with 17 Gy dose-reduction to the urethra. Intrafraction motion was monitored using intraprostatic electromagnetic transponders with intra-fraction correction of displacements exceeding 3 mm. Genitourinary (GU), gastrointestinal (GI), and sexual toxicity during the first 18 months were evaluated using the CTCAE v4.0 grading scale. Quality of life was assessed using the International Prostate Symptom Score, the Expanded Prostate Cancer Index composite 26 score, and the International Index of Erectile Function score. RESULTS: Among the 45 patients recruited in 5 centers between 2017 and 2022, 43 received the single fraction without protocol deviations, and 34 had a minimal follow-up of 18 months. The worst GU toxicity was observed at day-5 after SBRT (42.5 % and 20 % with grade 1 and 2, respectively), returning to baseline at week-12 and month-6 (<3% with grade 2), with a 12 % grade 2 flare at month 18. Gl toxicity was mild in the acute phase, with no grade ≥ 2 events (12 % grade 1 at month 6). Grade-3 proctitis was observed in one patient at month 12, with < 3 % grade 2 toxicity at month 18. Mean GU and GI bother scores showed a decline at day 5, a complete recovery at month 6, and a flare between month 12 and 18. Mean PSA dropped from 6.2 ng/ml to 1.2 ng/ml at month 18 and 0.7 ng/ml at month 24. After a median follow-up time of 26 months, 3 biochemical failures (7 %) were observed at month 17, 21 and 30. CONCLUSIONS: In this multicenter phase I/II trial, we demonstrated that a 19 Gy single-fraction urethra-sparing SBRT is feasible and associated with an acceptable toxicity rate, mostly returning to the baseline at week-12 and with a symptoms flare between months 12 and 18. Longer follow-up is needed to assess the potential long-term adverse effects and the disease control efficacy.

State of the art and future challenges of urethra-sparing stereotactic body radiotherapy for prostate cancer: a systematic review of literature.

PURPOSE: Doses delivered to the urethra have been associated with an increased risk to develop long-term urinary toxicity in patients undergoing stereotactic body radiotherapy (SBRT) for prostate cancer (PCa). Aim of the present systematic review is to report on the role of urethra-sparing SBRT (US-SBRT) techniques for prostate cancer, with a focus on outcome and urinary toxicity. METHOD: A systematic review of the literature was performed on the PubMed database on May 2023. Based on the urethra-sparing technique, 13 studies were selected for the analysis and classified in the two following categories: "urethra-steering" SBRT (restriction of hotspots to the urethra) and "urethra dose-reduction" SBRT (dose reduction to urethra below the prescribed dose). RESULTS: By limiting the urethra Dmax to 90GyEQD2 (α/ß = 3 Gy) with urethra-steering SBRT techniques, late genitourinary (GU) grade 2 toxicity remains mild, ranging between 12.1% and 14%. With dose-reduction strategies decreasing the urethral dose below 70 GyEQD2, the risk of late GU toxicity was further reduced (< 8% at 5 years), while maintaining biochemical relapse-free survival rates up to 93% at 5 years. CONCLUSION: US-SBRT techniques limiting maximum doses to urethra below a 90GyEQD2 (α/ß = 3 Gy) threshold result in a low rate of acute and late grade ≥ 2 GU toxicity. A better understanding of clinical factors and anatomical substructures involved in the development of GU toxicity, as well as the development and use of adapted dose constraints, is expected to further reduce the long-term GU toxicity of prostate cancer patients treated with SBRT.

Predictors of Urinary Continence Recovery after Laparoscopic-Assisted Radical Prostatectomy: Is Surgical Urethral Length the Only Key Factor?

Several efforts in recent years have been made to predict urinary continence (UC) recovery after radical prostatectomy. The aim of our study was to investigate the impact of surgical urethral length preservation (SULP) on urinary continence after LARP (laparoscopic-assisted radical prostatectomy). We retrospectively queried our datasets from May 2021 to May 2022. After the application of exclusion criteria, a total of 100 patients who underwent LARP for prostate cancer at our institution were enrolled. Through a sterile ruler inserted by a 12 mm trocar, the length of the membranous urethra spared during LARP was assessed intra-operatively. The baseline and peri- and postoperative data of patients were collected, and UC was defined as 0 or 1 on a safety pad. The median SULP was 20.5 mm (IQR, 14.5-25), and the median intraoperative EBL were 150 mL (IQR, 100-200). The Kaplan-Meier curve showed a significant difference at 20 mm, which was used as the cut-off value for SULP (log-rank test, p < 0.001). Multivariate Cox proportional hazards models showed that SULP and EBL < 250 mL were associated with UC recovery (all p < 0.02). Surgical urethral length preservation seemed to improve early UC recovery after LARP. Further multicentric studies are needed to confirm our findings.

A treatment planning study of urethra-sparing intensity-modulated proton therapy for localized prostate cancer.

BACKGROUND AND PURPOSE: Urethra-sparing radiation therapy for localized prostate cancer can reduce the risk of radiation-induced genitourinary toxicity by intentionally underdosing the periurethral transitional zone. We aimed to compare the clinical impact of a urethra-sparing intensity-modulated proton therapy (US-IMPT) plan with that of conventional clinical plans without urethral dose reduction. MATERIALS AND METHODS: This study included 13 patients who had undergone proton beam therapy. The prescribed dose was 63 GyE in 21 fractions for 99% of the clinical target volume. To compare the clinical impact of the US-IMPT plan with that of the conventional clinical plan, tumor control probability (TCP) and normal tissue complication probability (NTCP) were calculated with a generalized equivalent uniform dose-based Lyman-Kutcher model using dose volume histograms. The endpoints of these model parameters for the rectum, bladder, and urethra were fistula, contraction, and urethral stricture, respectively. RESULTS: The mean NTCP value for the urethra in US-IMPT was significantly lower than that in the conventional clinical plan (0.6% vs. 1.2%, p < 0.05). There were no statistically significant differences between the conventional and US-IMPT plans regarding the mean minimum dose for the urethra with a 3-mm margin, TCP value, and NTCP value for the rectum and bladder. Additionally, the target dose coverage of all plans in the robustness analysis was within the clinically acceptable range. CONCLUSIONS: Compared with the conventional clinically applied plans, US-IMPT plans have potential clinical advantages and may reduce the risk of genitourinary toxicities, while maintaining the same TCP and NTCP in the rectum and bladder.

Visualizing the urethra by magnetic resonance imaging without usage of a catheter for radiotherapy of prostate cancer.

The urethra position may shift due to the presence/absence of the catheter. Our proposed post-urination-magnetic resonance imaging (PU-MRI) technique is possible to identify the urethra without catheter. We aimed to verify the inter-operator difference in contouring the urethra by PU-MRI. The mean values of the evaluation indices of dice similarity coefficient, mean slice-wise Hausdorff distance, and center coordinates were 0.93, 0.17 mm, and 0.36 mm for computed tomography, and 0.75, 0.44 mm, and 1.00 mm for PU-MRI. Therefore, PU-MRI might be useful for identifying the prostatic urinary tract without using a urethral catheter. Clinical trial registration: Hokkaido University Hospital for Clinical Research (018-0221).

Urethra-sparing surgery for a prostate cancer lesion in the anterior urethral zone with magnetic resonance-guided focused ultrasound: a case report.

Prostate cancer (PCa) is the most common malignancy among men worldwide. High-intensity focused ultrasound (HIFU) is a focal therapeutic strategy for low- to intermediate-risk PCa with a low risk of complications. However, lesions located in the anterior urethral zone are challenging to treat with this approach because it is difficult to avoid urethral injury during HIFU therapy, which might further cause urethral stricture and symptoms related to bladder outlet obstruction (BOO). Here, we present the case of a 79-year-old male with elevated prostate-specific antigen (PSA) levels for over 1 year. Multiparametric magnetic resonance imaging revealed a 1.8 cm × 1.0 cm mass covering an area of the anterior urethral zone. Histopathological examination revealed an International Society of Urological Pathology grade group 3 acinar adenocarcinoma. Given the patient's request for functional preservation, a magnetic resonance-guided focused ultrasound surgery was performed. During the operation, a urethra-sparing approach was utilized by administering proper energy and adjusting the sequence of the sonications. The patient developed urinary retention after catheter removal less than 48 h after the treatment, which resolved after removal of the second catheter a week later. On a follow-up visit 3 months after the treatment, evaluation by the level of PSA and multiparametric magnetic resonance imaging showed no recurrence of PCa. No significant changes in the International Prostate Symptom Score and Quality of Life score were found compared to baseline scores. With proper adjustment, magnetic resonance-guided focused ultrasound surgery could be safely used for urethra-sparing surgeries for PCa lesions in the anterior urethral zone, without influencing post-treatment urination. The indwelling time of the catheter should be extended appropriately for full recovery from treatment-related prostatic edema around the prostatic urethra to avoid urinary retention.

Once-a-week or every-other-day urethra-sparing prostate cancer stereotactic body radiotherapy, a randomized phase II trial: 18 months follow-up results.

BACKGROUND: To present the 18 months results from a prospective multicenter phase II randomized trial of short vs protracted urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer (PCa). METHODS: Between 2012 and 2015, a total of 170 PCa patients were randomized to 36.25 Gy in 5 fractions (6.5 Gy × 5 to the urethra) delivered either every other day (EOD, arm A, n = 84) or once a week (QW, arm B, n = 86). Genitourinary (GU) and gastrointestinal (GI) toxicity (CTCAE v4.0 scale), IPSS, and QoL scores were assessed at baseline, at the 5th fraction (5fx), 12th weeks (12W), and every 6 months after SBRT. The primary endpoint was biochemical control at 18 months and grade ≥ 3 toxicity (including grade ≥ 2 for urinary obstruction/retention) during the first 3 months. RESULTS: Among the 165 patients analyzed, the toxicity stopping rule was never activated during the acute phase. Maximum acute grade 2 GU toxicity rates at 5fx were 17% and 19% for arms A and B, respectively, with only 2 cases of grade 2 GI toxicity at 5fx in arm A. At month 18, grade ≥ 2 GU and GI toxicity decreased below 5% and 2% for both arms. No changes in EORTC QLQ-PR25 scores for GU, GI, and sexual domains were observed in both arms between baseline and month 18. Four biochemical failures were observed, 2 in each arm, rejecting the null hypothesis of an unfavorable response rate ≤ 85% in favor of an acceptable ≥ 95% rate. CONCLUSIONS: At 18 months, urethra-sparing SBRT showed a low toxicity profile, with minimal impact on QoL and favorable biochemical control rates, regardless of overall treatment time (EOD vs QW).

Prospective multicentre study using high intensity focused ultrasound (HIFU) for the focal treatment of prostate cancer: Safety outcomes and complications.

PURPOSE: To investigate focal therapy using High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer (CaP), we analyzed the safety and complications of this procedure. METHODS: Patients (pts) eligible for this multicenter prospective cohort study suffered from low to intermediate risk localized CaP with no prior treatment. After tumor identification on multiparametric MRI and in prostate biopsy, the lesions were treated with HIFU observing a safety margin of 8 to 10 mm. Adverse events (AE) after 30 and 90 days, as well as the required interventions were assessed and stratified for treatment localizations. RESULTS: Of the 98 men included in the study in two European centers, 35 (35.7%) experienced AEs in the first 30 days after HIFU intervention with Clavien-Dindo grade ≤ II: 15 pts (15.3%) had a postoperative urinary tract infection and 26 pts (26.5%) a urinary retention. Four pts (4.1%) underwent subsequent intervention (Clavien-Dindo grade IIIa/b). The number of late postoperative complications occurring between 30 and 90 days after intervention was low (2.0%). The highest complication rate was associated with tumors located at the anterior base (50.0%). The inclusion of the urethra in the ablation zone led to AEs in 20 out of 41 cases (48.8%) and represented a significant risk factor for complications within 30 days (odds ratio = 2.53; 95% confidence interval: 1.08-5.96; P = 0.033). CONCLUSIONS: Focal therapy of CaP lesions with a robotic HIFU-probe is safe and renders an acceptable rate of minor early AEs. The inclusion of the urethra in the ablation zone leads to an increase in early complications and should be avoided whenever possible.

Organ-sparing procedures in GU cancer: part 3-organ-sparing procedures in urothelial cancer of upper tract, bladder and urethra.

PURPOSE: The impact of radical surgery for urothelial carcinoma is significant on patient's quality of life. Organ-sparing surgery (OSS) can provide comparable oncological outcomes and with improved quality of life. In this review, we summarize the indications, techniques and outcomes of OSS for these tumors. METHODS: PubMed® was searched for relevant articles. Keywords used were: for upper tract urothelial carcinoma (UTUC): endoscopic, ureteroscopic/percutaneous management, laser ablation; for urothelial bladder cancer: bladder preservation, trimodal therapy, muscle invasive bladder cancer (MIBC); for urethral cancer: urethra/penile-sparing, urethral carcinoma. RESULTS: Kidney-sparing surgery is an option in patients with low-risk UTUC with better renal function preservation and comparable oncological control to radical nephroureterectomy. In select patients with MIBC, trimodal therapy has better quality of life and comparable oncological control to radical cystectomy. In distal male urethral cancer, penile conserving surgery is feasible and offers acceptable survival outcomes. In female urethral cancer, organ preservation can be achieved, in addition to OSS, through radiation. CONCLUSIONS: In the appropriately selected patient, OSS in upper tract, bladder and urethral carcinoma has comparable oncological outcomes to radical surgery and with the additional benefit of improved quality of life.

ONE SHOT - single shot radiotherapy for localized prostate cancer: study protocol of a single arm, multicenter phase I/II trial.

BACKGROUND: Stereotactic body radiotherapy (SBRT) is an emerging treatment alternative for patients with localized prostate cancer. Promising results in terms of disease control and toxicity have been reported with 4 to 5 SBRT fractions. However, question of how far can the number of fractions with SBRT be reduced is a challenging research matter. As already explored by some authors in the context of brachytherapy, monotherapy appears to be feasible with an acceptable toxicity profile and a promising outcome. The aim of this multicenter phase I/II prospective trialis to demonstrate early evidence of safety and efficacy of a single-fraction SBRT approach for the treatment of localized disease. METHODS: Patients with low- and intermediate-risk localized prostate cancer without significant tumor in the transitional zone will be treated with a single SBRT fraction of 19 Gy to the whole prostate gland with urethra-sparing (17 Gy). Intrafractional motion will be monitored with intraprostatic electromagnetic transponders. The primary endpoint of the phase I part of the study will be safety as assessed by CTCAE 4.03 grading scale, while biochemical relapse-free survival will be the endpoint for the phase II. The secondary endpoints include acute and late toxicity, quality of life, progression-free survival, and prostate-cancer specific survival. DISCUSSION: This is the first multicenter phase I/II trial assessing the efficacy and safety of a single-dose SBRT treatment for patients with localized prostate cancer. If positive, results of ONE SHOT may help to design subsequent phase III trials exploring the role of SBRT monotherapy in the exclusive radiotherapy treatment of localized disease. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03294889 ; Registered 27 September 2017.

Urethra-sparing stereotactic body radiotherapy for prostate cancer: how much can the rectal wall dose be reduced with or without an endorectal balloon?

BACKGROUND: This is a dosimetric comparative study intended to establish appropriate low-to-intermediate dose-constraints for the rectal wall (Rwall) in the context of a randomized phase-II trial on urethra-sparing stereotactic body radiotherapy (SBRT) for prostate cancer. The effect of plan optimization on low-to-intermediate Rwall dose and the potential benefit of an endorectal balloon (ERB) are investigated. METHODS: Ten prostate cancer patients, simulated with and without an ERB, were planned to receive 36.25Gy (7.25Gyx5) to the planning treatment volume (PTV) and 32.5Gy to the urethral planning risk volume (uPRV). Reference plans with and without the ERB, optimized with respect to PTV and uPRV coverage objectives and the organs at risk dose constraints, were further optimized using a standardized stepwise approach to push down dose constraints to the Rwall in the low to intermediate range in five sequential steps to obtain paired plans with and without ERB (Vm1 to Vm5). Homogeneity index for the PTV and the uPRV, and the Dice similarity coefficient (DSC) for the PTV were analyzed. Dosimetric parameters for Rwall including the median dose and the dose received by 10 to 60% of the Rwall, bladder wall (Bwall) and femoral heads (FHeads) were compared. The monitor units (MU) per plan were recorded. RESULTS: Vm4 reduced by half D30%, D40%, D50%, and Dmed for Rwall and decreased by a third D60% while HIPTV, HIuPRV and DSC remained stable with and without ERB compared to Vmref. HIPTV worsened at Vm5 both with and without ERB. No statistical differences were observed between paired plans on Rwall, Bwall except a higher D2% for Fheads with and without an ERB. CONCLUSIONS: Further optimization to the Rwall in the context of urethra sparing prostate SBRT is feasible without compromising the dose homogeneity to the target. Independent of the use or not of an ERB, low-to-intermediate doses to the Rwall can be significantly reduced using a four-step sequential optimization approach.

Urethra-sparing high-intensity focused ultrasound for localized prostate cancer: Functional and oncological outcomes.

OBJECTIVES: To evaluate longitudinal changes in urinary function and quality of life, and the oncological outcomes of patients treated with urethra-sparing high-intensity focused ultrasound for localized prostate cancer. METHODS: Patients with negative findings in the urethra and the anterior urethral zone using transrectal ultrasound-guided targeted biopsies, and magnetic resonance imaging, received urethra-sparing or whole-gland high-intensity focused ultrasound as the primary therapy for localized prostate cancer without transurethral resection of the prostate. Longitudinal changes in urinary function and quality of life, and the oncological outcomes of the patients were analyzed retrospectively. RESULTS: The median follow-up times for urethra-sparing and whole-gland high-intensity focused ultrasound were 36 and 30 months, respectively. Comparing the patients treated with urethra-sparing high-intensity focused ultrasound (n = 45) with those treated with whole-gland high-intensity focused ultrasound (n = 65), there were significant differences in the International Prostate Symptom Score (P = 0.014) at 3 months, International Prostate Symptom Score quality of life (P = 0.033) at 3 months, maximum urinary flow rate (mL/s; at 3 months, P = 0.010; at 6 months, P = 0.038) and residual urine volume (mL; at 3 months, P < 0.0001; at 6 months, P = 0.016; at 12 months, P = 0.028). For quality of life, there were significant differences in Functional Assessment of Cancer Therapy - General (at 3 months, P = 0.022) and Functional Assessment of Cancer Therapy - Prostate (at 3 months, P = 0.028; at 6 months, P = 0.034). There were no significant differences in oncological outcomes regarding negative biopsy rates on follow up (91% vs 92%; P = 0.8) or biochemical disease-free survival rates (86.7% vs 89.2%; P = 0.7). CONCLUSIONS: Urethra-sparing high-intensity focused ultrasound might prevent prolonged bladder outlet obstruction, and could be a treatment option for localized prostate cancer.

EAU guidelines on primary urethral carcinoma.

CONTEXT: The European Association of Urology (EAU) Guidelines Group on Muscle-Invasive and Metastatic Bladder Cancer prepared these guidelines to deliver current evidence-based information on the diagnosis and treatment of patients with primary urethral carcinoma (UC). OBJECTIVE: To review the current literature on the diagnosis and treatment of patients with primary UC and assess its level of scientific evidence. EVIDENCE ACQUISITION: A systematic literature search was performed to identify studies reporting urethral malignancies. Medline was searched using the controlled vocabulary of the Medical Subject Headings database, along with a free-text protocol. EVIDENCE SYNTHESIS: Primary UC is considered a rare cancer, accounting for <1% of all malignancies. Risk factors for survival include age, tumour stage and grade, nodal stage, presence of distant metastasis, histologic type, tumour size, tumour location, and modality of treatment. Pelvic magnetic resonance imaging is the preferred method to assess the local extent of urethral tumour; computed tomography of the thorax and abdomen should be used to assess distant metastasis. In localised anterior UC, urethra-sparing surgery is an alternative to primary urethrectomy in both sexes, provided negative surgical margins can be achieved. Patients with locally advanced UC should be discussed by a multidisciplinary team of urologists, radiation oncologists, and oncologists. Patients with noninvasive UC or carcinoma in situ of the prostatic urethra and prostatic ducts can be treated with a urethra-sparing approach with transurethral resection and bacillus Calmette-Guérin (BCG). Cystoprostatectomy with extended pelvic lymphadenectomy should be reserved for patients not responding to BCG or as a primary treatment option in patients with extensive ductal or stromal involvement. CONCLUSIONS: The 2013 guidelines document on primary UC is the first publication on this topic by the EAU. It aims to increase awareness in the urologic community and provide scientific transparency to improve outcomes of this rare urogenital malignancy.