Treatment Of Localized Prostate Cancer Research Articles

Targeted microwave ablation for prostate cancer (FOSTINE1b): a prospective 'ablate-and-resect' study.

To assess histopathological outcomes, as well as feasibility and safety of targeted microwave ablation (TMA) via the Trinity® system (KOELIS, La Tronche, France). Prospective, single-institution, interventional Phase IIa study with an 'ablate-and-resect' design. In all, 11 patients diagnosed with localised prostate cancer (PCa) underwent TMA via the Trinity system under conscious sedation in an outpatient setting using a single transrectal TATO® 18-G antenna with different treatment regimens. Magnetic resonance imaging (MRI) and robot-assisted radical prostatectomy (RARP) were conducted at 7 days and 1 month after TMA, respectively. Nine patients received RARP, and two patients chose to withdraw their consent following TMA. These men chose an active surveillance protocol upon confirmation of a low-risk prostate cancer diagnosis. Functional outcomes and adverse events were evaluated at baseline and follow-up visits using validated questionnaires. Prostate volumetry and confirmation of necrosis were carried out through MRI and whole-mount histopathological examination. The TMA was successfully executed, and all patients were discharged on the same day. No severe adverse events (Common Terminology Criteria for Adverse Events Grade ≥3) were reported at the 7-day and 1-month follow-up visits. Additionally, no declines were observed in urinary, sexual and ejaculation functional outcomes. T1-weighted MRI revealed clear and well-defined ablation zones. The RARP was executed without difficulty, particularly during the dissection of the posterior plane. As a result, no intraoperative complications were encountered. Histopathological assessment on surgical specimens confirmed the absence of viable cells, indicating complete necrosis of the ablative zone if a power intensity >10 W was used during TMA. Ablation zone volumetry revealed no notable distinctions between the three-dimensional segmentation of the virtual ablation zone at TMA (median volume: 2 mL) and MRI (median volume: 1.923 mL). Conversely, a significant reduction was noted in the surgical specimen (median volume: 0.221 mL). Targeted microwave ablation via the Trinity system for localised PCa treatment proves to be a secure and feasible procedure, with complete necrosis evidence within the ablation zone on surgical specimens.

Anorectal function and symptoms 6 months after robot-assisted laparoscopic radical prostatectomy: a single-center study.

Robot-assisted laparoscopic radical prostatectomy (RALP) is a common procedure for the treatment of localised prostate cancer. Anorectal symptoms such as fecal incontinence (FI), rectal urgency or disturbed defecation have been reported after the operation. Anorectal function is dependent on the integrity of anal and pelvic nerves and muscles, rectal sensory function as well as rectal reservoir function. The aim of this study was to investigate the potential influence of RALP on anorectal physiological function and bowel symptoms. In this pilot study, 29 patients with localised prostate cancer scheduled for RALP were included. Anorectal physiology was used to measure rectal sensitivity and reservoir function as well as anal sphincter pressures. Bowel symptoms were measured by a bowel function questionnaire and a 2-week bowel function diary. Measurements were done before the operation and repeated at 6 months after the operation. The study observed a significant postoperative increase in rectal sensory threshold for rectal balloon distention, from 20 to 40 mmHg, P < 0.001. This change is indicative of a decrease in rectal sensation after RALP. There were no other statistical significant differences in any of the physiological tests performed. Importantly, there was no change in any of the bowel symptoms after surgery. This study showed that RALP may lead to impaired rectal sensory function. This finding did not, however, seem to have any influence on the patients´ postoperative clinical bowel function.

Increasing the radiation-induced cytotoxicity by silver nanoparticles and docetaxel in prostate cancer cells.

Radiation therapy is utilized for treatment of localized prostate cancer. Nevertheless, cancerous cells frequently develop radiation resistance. While higher radiation doses have not always been effective, radiosensitizers have been extensively studied for their ability to enhance the cytotoxic effects of radiation.So, this study aims to evaluate the possible radiosensitization effects of docetaxel (DTX) and silver nanoparticles (SNP) in LNCaP cells. The cytotoxic effects of DTX, SNP and2Gy of X-Ray radiation treatments were assessed in human LNCaP cell line using the MTT test after 24 h. Moreover, the effects of DTX, SNP and radiation on Epidermal growth factor (EGF), Caspase 3, inducible nitric oxide synthase and E-cadherin gene expression were analyzed using the Real-time PCR method. The level of Hydrogen peroxide (H2O2), an oxidative stress marker, was also detected 24h after various single and combined treatments. The combinations of SNP (in low toxic concentration) and/or DTX (0.25× IC50 and 0.5 × IC50 concentrations for triple and double combinations respectively) with radiation induced significant cytotoxicity in LNCaP cells in comparison to monotherapies. These cytotoxic effects were associated with the downregulation of EGF mRNA. Additionally, H2O2 levels increased after Radiation + SNP + DTX triple combination and double combinations including Radiation + SNP and Radiation + DTX versus single treatments. The triple combination treatment also increased Caspase 3 and and E-cadherin mRNA levels in compared to single treatments in LNCaP cells. Our results indicate that the combination of SNP and DTX with radiation induces significant anti-cancer effects. Upregulation of Caspase 3 and E-cadherin gene expression, and decreased mRNA expression level of EGF may be exerted specifically by use of this combination versus single treatments.

Predictors of surgical difficulty according to surgical proficiency in robot-assisted radical prostatectomy.

Robot-assisted radical prostatectomy (RARP) is a standard treatment for localized prostate cancer. We previously reported that a large amount of pelvic visceral fat and a small working space, as measured by three-dimensional image analysis, were significantly associated with prolonged console time in RARP, and these factors could be alternatives to the more clinically practical body mass index (BMI) and pelvic width (PW), respectively. Herein, we further investigated whether surgical proficiency affected surgical difficulty as measured by console time. Medical records of 413 patients who underwent RARP between 2014 and 2020 at our institution were reviewed. Surgeons who had experience with over and under 100 cases were defined as "experienced" and "non-experienced," respectively. Multivariate logistic regression analyses were performed to identify factors that prolonged console time. The median console times for RARP by experienced and non-experienced surgeons were 87.5 and 149.0min, respectively; a difficult case was defined as one requiring time greater than the median. Among inexperienced surgeons, higher BMI (p < 0.001, odds ratio: 1.89) and smaller PW (p = 0.001, odds ratio: 1.86) were significant factors that increased console time; the complication rate was increased in patients with these factors. However, these factors did not significantly affect the console time or complication rate among experienced surgeons. This study demonstrates that experienced surgeons may be able to overcome obesity- and small workspace-related surgical difficulties. The current analysis may provide useful information regarding unpredictable surgical risks and identify suitable cases for novices.

Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial

Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60-69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative radiotherapy at 138 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 8·9 years (7·0-10·0), 313 metastasis-free survival events were reported overall (174 in the short-course ADT group and 139 in the long-course ADT group; HR 0·773 [95% CI 0·612-0·975]; p=0·029). 10-year metastasis-free survival was 71·9% (95% CI 67·6-75·7) in the short-course ADT group and 78·1% (74·2-81·5) in the long-course ADT group. Toxicity of grade 3 or higher was reported for 105 (14%) of 753 participants in the short-course ADT group and 142 (19%) of 757 participants in the long-course ADT group (p=0·025), with no treatment-related deaths. Compared with adding 6 months of ADT, adding 24 months of ADT improved metastasis-free survival in people receiving postoperative radiotherapy. For individuals who can accept the additional duration of adverse effects, long-course ADT should be offered with postoperative radiotherapy. Cancer Research UK, UK Research and Innovation (formerly Medical Research Council), and Canadian Cancer Society.

Impact of neoadjuvant relugolix on patient-reported sexual function and bother.

Sexual function following local treatment for prostate cancer is an important quality of life concern. Relugolix is a novel oral GnRH receptor antagonist used in combination with radiation therapy in the treatment of unfavorable prostate cancer. It has been shown to achieve rapid and profound testosterone suppression. As a result, these very low testosterone levels may impact both sexual functioning and perceptions. This prospective study sought to assess neoadjuvant relugolix-induced sexual dysfunction prior to stereotactic body radiation therapy (SBRT). Between March 2021 and September 2023, 87 patients with localized prostate cancer were treated with neoadjuvant relugolix followed by SBRT per an institutional protocol. Sexual function and bother were assessed via the sexual domain of the validated Expanded Prostate Index Composite (EPIC-26) survey. Responses were collected for each patient at pre-treatment baseline and after several months of relugolix. A Utilization of Sexual Medications/Devices questionnaire was administered at the same time points to assess erectile aid usage. The median age was 72 years and 43% of patients were non-white. The median baseline Sexual Health Inventory for Men (SHIM) score was 13 and 41.7% of patients utilized sexual aids prior to relugolix. Patients initiated relugolix at a median of 4.5 months (2-14 months) prior to SBRT. 95% and 87% of patients achieved effective castration (≤ 50 ng/dL) and profound castration (< 20 ng/dl) at SBRT initiation, respectively. Ability to have an erection, ability to reach orgasm, quality of erections, frequency of erections, and overall sexual function significantly declined following relugolix. There was a non- significant increase in sexual bother. In concordance with known side effects of androgen deprivation therapy (ADT), neoadjuvant relugolix was associated with a significant decline in self-reported sexual function. However, patients indicated only a minimal and non-significant increase in bother. Future investigations should compare outcomes while on relugolix directly to GnRH agonist-induced sexual dysfunction.

Association Between Acute Kidney Injury and the Trendelenburg Position Angle During Robot-assisted Radical Prostatectomy.

Robot-assisted radical prostatectomy (RARP) has been widely adopted as the standard treatment for localized prostate cancer. RARP is safer and results in better oncological control than conventional open total prostatectomy. However, it has also been reported that acute kidney injury (AKI) can be caused by the use of carbon dioxide pneumoperitoneum and a steep Trendelenburg position. We investigated the incidence of AKI after RARP and its relationship with the Trendelenburg position angle. Seventy-seven patients underwent RARP at our institution. They were divided into two groups: Those in which a Trendelenburg position with the head down at 20 degrees was employed (group A) and those in which a Trendelenburg position with the head down at 25 degrees was used (group B). To detect AKI, the serum creatinine concentration was measured at the following four points: Prior to surgery, on postoperative day 0 (immediately after RARP), and on postoperative days 1 and 6 after RARP. The incidence of AKI on POD 0 was lower in group B than in group A (p=0.0408). On POD 6, the renal function of all patients had improved to preoperative levels. Hypertension was a predictor of the incidence of AKI immediately after RARP. Although there was a significant Trendelenburg position angle-dependent difference in the incidence of AKI immediately after RARP, it was temporary. Hypertension is a predictor of AKI immediately after RARP. It is recommended that a 25-degree Trendelenburg position angle should be employed during RARP.

Abstract 3845: High-intensity focused ultrasound ablation increases tumor specific lymphocytes in prostate cancer

Abstract The treatment of localized prostate cancer has been revolutionized by High-Intensity Focused Ultrasound (HIFU), an FDA-approved procedure. Thermal HIFU achieves the destruction of tumor tissue through the noninvasive delivery of ultrasonic energy, causing rapid heating of the targeted area. Given that prostate cancer typically exhibits a low presence of tumor-infiltrating lymphocytes crucial for antitumor immunity, this study aimed to investigate whether HIFU has the potential to activate antitumor immunity and enhance lymphocyte infiltration within the tumor. RM1 tumors were implanted on the flanks of syngeneic C57BL/6J mice, with one tumor subjected to HIFU treatment. The growth of the contralateral tumor was monitored, and at the end of the study, tumors were collected to evaluate immune cell infiltration. Blood samples were obtained from patients both before and after prostatectomy or HIFU treatment. Peripheral blood mononuclear cells (PBMCs) were then isolated to analyze the immune cell population. In murine experiments, the application of HIFU to one tumor resulted in a reduction in the growth of the contralateral (untreated) tumor, specifically when the contralateral tumor was of the same type, but not when it was a different tumor type. Notably, HIFU led to an augmented infiltration of CD4+ and CD8+ lymphocytes into the contralateral (untreated) tumor. Depletion studies further affirmed that the antitumor immune response triggered by HIFU relies on CD4+ and CD8+ lymphocytes. In human subjects, HIFU was observed to elevate the CD4+ and CD8+ lymphocyte populations in PBMCs. HIFU induces a potent antitumor immune response that effectively inhibits the progression of murine prostate tumors. This immune response is contingent upon CD4+ and CD8+ lymphocytes. HIFU demonstrates significant promise in activating antitumor immune responses in patients diagnosed with prostate cancer. Subsequent research endeavors should delve into models of metastatic prostate cancer, exploring the potential synergy of cytoreductive prostate tumor ablation with systemic immunotherapies to elicit a robust and comprehensive antitumor immune response. Citation Format: Shengchen Su, Yanping Wang, Eric M. Lo, Hyung L. Kim. High-intensity focused ultrasound ablation increases tumor specific lymphocytes in prostate cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 3845.

High-intensity focused ultrasound with visually directed power adjustment for focal treatment of localized prostate cancer: systematic review and meta-analysis

PurposeTo characterize patient outcomes following visually directed high-intensity focused ultrasound (HIFU) for focal treatment of localized prostate cancer.MethodsWe performed a systematic review of cancer-control outcomes and complication rates among men with localized prostate cancer treated with visually directed focal HIFU. Study outcomes were calculated using a random-effects meta-analysis model.ResultsA total of 8 observational studies with 1,819 patients (median age 67 years; prostate-specific antigen 7.1 mg/ml; prostate volume 36 ml) followed over a median of 24 months were included. The mean prostate-specific antigen nadir following visually directed focal HIFU was 2.2 ng/ml (95% CI 0.9–3.5 ng/ml), achieved after a median of 6 months post-treatment. A clinically significant positive biopsy was identified in 19.8% (95% CI 12.4–28.3%) of cases. Salvage treatment rates were 16.2% (95% CI 9.7–23.8%) for focal- or whole-gland treatment, and 8.6% (95% CI 6.1–11.5%) for whole-gland treatment. Complication rates were 16.7% (95% CI 9.9–24.6%) for de novo erectile dysfunction, 6.2% (95% CI 0.0–19.0%) for urinary retention, 3.0% (95% CI 2.1–3.9%) for urinary tract infection, 1.9% (95% CI 0.1–5.3%) for urinary incontinence, and 0.1% (95% CI 0.0–1.4%) for bowel injury.ConclusionLimited evidence from eight observational studies demonstrated that visually directed HIFU for focal treatment of localized prostate cancer was associated with a relatively low risk of complications and acceptable cancer control over medium-term follow-up. Comparative, long-term safety and effectiveness results with visually directed focal HIFU are lacking.

Radiotherapy in localized prostate cancer: amulticenter analysis evaluating tumor control and late toxicity after brachytherapy and external beam radiotherapy in 1293 patients.

Comparing oncological outcomes and toxicity after primary treatment of localized prostate cancer using HDR- or LDR-mono-brachytherapy (BT), or conventionally (CF) or moderately hypofractionated (HF) external beam radiotherapy. Retrospectively, patients with low- (LR) or favorable intermediate-risk (IR) prostate cancer treated between 03/2000 and 09/2022 in two centers were included. Treatment was performed using either CF with total doses between 74and 78 Gy, HF with 2.4-2.6 Gy per fraction in 30fractions, or LDR- or HDR-BT. Biochemical control (BC) according to the Phoenix criteria, and late gastrointestinal (GI), and genitourinary (GU) toxicity according to RTOG/EORTC criteria were assessed. We identified 1293 patients, 697 with LR and 596 with IR prostate cancer. Of these, 470, 182, 480, and 161 were treated with CF, HF, LDR-BT, and HDR-BT, respectively. For BC, we did not find asignificant difference between treatments in LR and IR (p = 0.31 and 0.72). The 5‑year BC for LR was between 93and 95% for all treatment types. For IR, BC was between 88% in the CF and 94% in the HF group. For CF and HF, maximum GI and GU toxicity grade ≥ 2 was between 22and 27%. For LDR-BT, we observed 67% grade ≥ 2 GU toxicity. Maximum GI grade ≥ 2 toxicity was 9%. For HDR-BT, we observed 1% GI grade ≥ 2 toxicity and 19% GU grade ≥ 2 toxicity. All types of therapy were effective and well received. HDR-BT caused the least late toxicities, especially GI.

A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR).

Both germline and somatic BReast CAncer gene (BRCA) mutations are poor prognostic markers in men with localized or metastatic prostate cancer. For instance, men with these mutations often are diagnosed with prostate cancer earlier and develop metastatic disease earlier compared with those who do not harbor similar mutations. Patients with germline alterations typically have more advanced disease and shorter overall survival (Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. J Clin Oncol. 2013;31(14):1748-1757. doi:10.1200/JCO.2012.43.1882). The risk of disease progression to metastatic disease is significant in patients with this genotype of prostate cancer. The percentage of patients free from metastatic disease was 90%, 72%, and 50%, respectively, compared with 97%, 94%, and 84% at 3, 5, and 10 years for patients with intact DNA repair (P < .001) (Castro E, Goh C, Leongamornlert D, et al. Effect of BRCA mutations on metastatic relapse and cause-specific survival after radical treatment for localised prostate cancer. Eur Urol. 2015;68(2):186-193. doi: 10.1016/j.eururo.2014.10.022). DNA damage repair non-BRCA mutations include alterations in genes such as ATM, CHEK2, PALB2, and RAD51. While less common than BRCA mutations, they have emerged as significant prognostic markers in prostate cancer. These BRCAness mutations are associated with a higher risk of aggressive disease and poorer survival outcomes. Given the debilitating physical and psychological side effects of androgen deprivation therapy (ADT) in relatively younger men with prostate cancer, delaying ADT in these men may be an attractive strategy. Given the proven efficacy of polyadenosine diphosphate-ribose polymerase (PARP) inhibitors in the castration-resistant prostate cancersetting, PARP inhibitor monotherapy in a nonmetastatic castration-sensitive (nmCSPC) setting has the potential to delay metastasis and delay the onset of ADT related symptoms. This is a single-arm, single-center, open-label, phase II trial to assess the efficacy of rucaparib in patients with high-risk biochemically recurrent (BCR) nmHSPC, which was defined as PSA doubling time of <9 months, demonstrating a "BRCAness" genotype (BRCA1/2 and other homologous recombination repair mutations). A total of 15 patients were intended to be enrolled, with an expected enrollment duration of 12 months. Patients were given rucaparib 600 mg orally twice daily and were allowed to remain on study treatment until PSA progression defined by Prostate Cancer Working Group 3, with 2 years of follow-up after study treatment. We anticipated a total of 2-3 years until completion of the clinical trial. The primary endpoint was to assess the PSA progression-free survival (PSA-PFS). The secondary endpoints of the study were safety, the proportion of patients with a PSA 50% response (PSA 50), and an undetectable PSA. A 4-week treatment duration comprised one cycle. The study started enrolling in June 2019 and was prematurely terminated in June 2022 after the accrual of 7 patients because of changing standard of care treatments with the introduction of next-generation scans, eg, prostate-specific membrane antigen positron emission tomography (PSMA-PET). Seven patients were enrolled in the study with the following pathogenic alterations: ATM (n = 3), BRCA2 (n = 2), BRCA1 (n = 1), BRIP1 (n = 1), and RAD51 (n = 1). The median duration of follow-up was 18 months. A median of 20 cycles (range 4-42) was completed, median PSA-PFS was 35.37 months (95% CI, 0-85.11 months). In total, 2 patients achieved PSA50; both also achieved nadir PSA as undetectable. Grade ≥ 3 adverse events (AEs) were anemia and rash (in 1 patient each). No dose-limiting toxicities or severe AEs were seen. Rucaparib demonstrated acceptable toxicity and efficacy signal as an ADT-sparing approach in patients with biochemically recurrent nonmetastatic prostate cancer. It is currently challenging to understand the optimal value of systemic therapy in this disease setting due to the rapidly changing standard of care. Additionally, there are relatively few patients with BRCAness who present with nonmetastatic hormone-sensitive prostate cancer (ClinicalTrials.gov Identifier: NCT03533946).

Comparison of sexual function after robot-assisted radical prostatectomy and carbon-ion radiotherapy for Japanese prostate cancer patients using propensity score matching

BackgroundThe quality of life of patients is an important consideration when selecting treatments for localized prostate cancer (PCa). We retrospectively compared sexual function after robot-assisted radical prostatectomy (RARP) and carbon-ion radiotherapy (CIRT) using propensity score matching.MethodsIn total, 127 Japanese PCa patients treated with RARP and 190 treated with CIRT monotherapy were evaluated. We evaluated the Expanded Prostate Cancer Index Composite (EPIC) score before treatment and 12 and 24 months after treatment. After propensity score matching, data from 101 patients from each group were analyzed. The study protocol was approved by the Institutional Review Board of Gunma University Hospital (no. IRB2020-050, 1839).ResultsAfter propensity score matching, the mean EPIC sexual function summary scores in the RARP and CIRT groups were 46.4 and 48.2, respectively. At 12 and 24 months after treatment, these scores were 27.9 (39.9% decrease) and 28.2 (39.2% decrease) in the RARP group and 41.4 (14.1% decrease) and 41.6 (13.7% decrease) in the CIRT group, respectively. Both groups demonstrated significantly decreased scores after 12 and 24 months of treatment compared to before treatment (all p < 0.05). At 12 and 24 months, the sexual function summary score was significantly higher in the CIRT group than in the RARP group (p < 0.001).ConclusionsThere was a smaller decrease in the EPIC sexual function score in the CIRT group than in the RARP group. These results provide useful information for treatment decision-making of Japanese PCa patients.

(099) A Preliminary Investigation on the Incidence of Complications and Patient Contentment Following the Surgical Implantation of Inflatable Penile Prosthesis After Salvage Radical Prostatectomy

Abstract Introduction Erectile dysfunction (ED) is a common complication post salvage radical prostatectomy (RP). Yet, there is scant data in the literature on complication rates and patient satisfaction in those that undergo inflatable penile prosthesis (IPP) insertion post salvage radical prostatectomy (RP) following targeted radiotherapy for treatment of localized prostate cancer. It is understood that these patients have a higher rate of complications as they have experienced both radiation and prostatectomy adverse events which could alter their overall satisfaction after prosthetic surgeries. Objective Our aim is to conduct a preliminary analysis of IPP complication rates and satisfaction rates in patients that had 3-piece IPP implantation following salvage radical prostatectomy. Methods A retrospective chart review from our institutional database was done from 2018 to 2021. The inclusion criteria were patients that had an inserted 3-piece IPP and a history of salvage RP following radiation therapy. Only patients that participated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire at least 6 months from implant date were included. Data on satisfaction, IPP infection rates, mechanical failure rates, and overall complications was also collected. Complications include hematoma, erosion, reservoir hernia. Results A total of 22 patients were included in the study. The median age (IQR) is 65 (64–67) years and the median time (IQR) from RP to IPP insertion is 23 (11–49) months. All patients were approached in a penoscrotal manner with submuscular placement of reservoir (Table 1). The satisfaction rate was high at 91.8% on follow up. Overall complications rate was observed in 2 patients. One patient had a mechanical pump failure at 37.9 months while another patient had signs and symptoms of scrotal wall infection at 15 months. Both devices were easily replaced with no post op complication and remained functional on further follow up. Conclusions In patients that underwent salvage prostatectomy IPP insertion, they reported high satisfaction rates and low complication rates despite the exposure to both prostate cancer treatments adverse events. Further research is needed to confirm the results obtained and to investigate the underlying causes for the observed outcomes. The scientific process is iterative, and the answers obtained from one study often lead to more questions and the need for additional investigations. Disclosure No.

Focal brachytherapy as definitive treatment for localized prostate cancer: A systematic review and meta-analysis

PURPOSEIn this systematic review and meta-analysis, we describe the oncologic and toxicity outcomes of definitive focal brachytherapy for prostate cancer. METHODS AND MATERIALSA PROSPERO registered study (CRD42023410170) was conducted following the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines. PubMed, Embase, and The Cochrane Library were searched for studies between 2000 and 2022. Two authors independently performed the initial search. Biochemical recurrence-free survival (bRFS) was defined as the primary endpoint for the meta-analysis. Generalized linear mixed-effects models were conducted to calculate effect size and quantify heterogeneity. We also describe the side effects and local recurrence patterns of focal brachytherapy. RESULTSTen studies were identified and included 315 patients treated using focal brachytherapy as a definitive treatment. Mean (SD) age was 67.65 (7.9) years and mean (SD) PSA was 7.15 (2.7) ng/mL. Most patients (n = 236, 75%) underwent LDR Brachytherapy and 25% received HDR brachytherapy. Among the participants, 147 (46.5%) had a Gleason score ≤6, and 169 (53.5%) had a Gleason score ≥7. Only 11 (3.5%) patients received ADT. Overall, bRFS rate at median follow-up 4 years (Range: 1–6.42 years) was 91% (95% confidence interval [CI], 82–95%). Acute Grade ≤ 2 GU and GI toxicities were reported in 22 (7%) and 11 (3.5%) patients, respectively. Late Grade ≤ 2 GU and GI toxicity were reported in 6 (2%) and 14 (4.4%) patients, respectively. One case of prostate hemorrhage due to improper foley removal was noted but otherwise no acute or late Grade 3 or higher GI or GU toxicity related to radiotherapy was reported. CONCLUSIONOverall, definitive focal brachytherapy has a favorable toxicity profile. Oncologic outcomes are yet to mature. The evidence is limited by the small number of studies with low patients’ number, across study heterogeneity, and possibility of publication bias.

Salvage high-dose rate brachytherapy for local recurrence of prostate cancer after radical prostatectomy

Background. The current need for optimization of salvage treatment methods is dictated by the growing expansion of indications for radical prostatectomy in many centers in the developed countries of the world.Aim. To evaluate the effectiveness, toxicity, and technical characteristics of high-dose rate brachytherapy in treatment of local prostate cancer (PCa) recurrences after radical prostatectomy.Materials and methods. Between January 2015 and December 2020, salvage high-dose rate brachytherapy was performed in 17 patients at the Russian Scientific Center of Roentgenology and Radiology for local recurrence of PCa after radical prostatectomy. All patients underwent multiparametric magnetic resonance imaging of the pelvis at the stage of primary diagnosis in order to determine macroscopic tissue component in the prostate bed area. To rule out regional and distant metastases, all patients underwent positron emission tomography with 18F- or 68Ga-labeled prostate-specific membrane antigen. All patients included in the study underwent perineal biopsy of the prostate bed and seminal vesicles.Results. Median follow-up in the treatment group was 35.7 (24–54) months. Overall survival was 100 %. Prostatespecific antigen-specific survival was 88.2 %. There were no local recurrences of PCa in the treatment group. In patients with local PCa recurrence, significant predictors of treatment failure were the presence of clinically extremely high risk of progression at initial diagnosis (p = 0.003), development of biochemical relapse up to 24 months after main treatment (p = 0.001), and increased blood level of prostate-specific antigen above 10 ng/mL during registration of biochemical relapse (p = 0.002).Conclusion. High-dose rate brachytherapy is a safe and effective salvage treatment for local recurrence of PCa after radical prostatectomy. In addition to the brachytherapy technique, the diagnostic stage is also of great importance providing visualization of the exact location of tumor recurrence.

Revolutionizing localized prostate cancer treatment: Stereotactic radiotherapy "Moroccan experience".

Prostate cancer is the most common urological cancer, and its incidence is increasing. Radical prostatectomy and radiotherapy are theprimary treatments for localized forms. Stereotactic Body RadioTherapy (SBRT), a new and innovative therapy, has been validated for some cancer localizations but not yet for localized prostate cancer. Our study aims to report the efficacy and tolerance results of SBRT for localized prostate cancer. This is a retrospective study of 27 patients with localized prostate cancer (CaP) who were treated with SBRT in our department from 2017 to 2021 using transponders for tumor tracking. The dose was 36.25 Gy delivered in five fractions of 7.25 Gy. The delineation and doses of organs at risk were determined based on the recommendations of the SFRO and the TG101 report of medical physics. All patients were treated using a latest-generation linear accelerator (True Beam STXÒ). Acute toxicities were observed in 33.3% of cases, with 22.2% grade 1 or 2 genitourinary (GU) and no grade 3 while 11.1% gastrointestinal (GI) toxicities were reported as grade 1-2 (7.4%) and one case grade 3 (3.7%). Late grade 1 or 2 GU toxicity was observed in 14.84% of cases, with no reports of late GI toxicity. After a 26-month follow-up period, the biochemical failure-free survival rate was 92.6%. The results of our study are consistent with the existing literature and support the safety and effectiveness of SBRT as a treatment option for localized prostate cancer (CaP). In the United States, both ASTRO and the NCCN recognize SBRT as a valid treatment option for localized CaP. Ongoing phase III trials are being conducted to further substantiate these long-term results and to establish SBRT as the future standard of care for localized CaP.

(284) A Preliminary Investigation on the Incidence of Complications and Patient Contentment Following the Surgical Implantation of Inflatable Penile Prosthesis After Salvage Radical Prostatectomy

Abstract Introduction Erectile dysfunction (ED) is a common complication post salvage radical prostatectomy (RP). Yet, there is scant data in the literature on complication rates and patient satisfaction in those that undergo inflatable penile prosthesis (IPP) insertion post salvage radical prostatectomy (RP) following targeted radiotherapy for treatment of localized prostate cancer. It is understood that these patients have a higher rate of complications as they have experienced both radiation and prostatectomy adverse events which could alter their overall satisfaction after prosthetic surgeries. Objective Our aim is to conduct a preliminary analysis of IPP complication rates and satisfaction rate in patients that had 3-piece IPP implantation following salvage radical prostatectomy. Methods A retrospective chart review from our institutional database was done from 2018 to 2021. The inclusion criteria were patients that had an inserted 3-piece IPP and a history of salvage RP following radiation therapy. Only patients that participated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire at least 6 months from implant date were included. Data on satisfaction, IPP infection rates, mechanical failure rates, and overall complications was also collected. Complications include hematoma, erosion, reservoir hernia. Results A total of 22 patients were included in the study. The median age (IQR) is 65 (64-67) years and the median time (IQR) from RP to IPP insertion is 23 (11-49) months. All patients were approached in a penoscrotal manner with submuscular placement of reservoir (Table 1). The satisfaction rate was high at 91.8% on follow up. Overall complications rate was observed in 2 patients. One patient had a mechanical pump failure at 37.9 months while another patient had signs and symptoms of scrotal wall infection at 15 months. Both devices were easily replaced with no post op complication and remained functional on further follow up. Conclusions In patients that underwent salvage prostatectomy IPP insertion, they reported high satisfaction rates and low complication rates despite the exposure to both prostate cancer treatments adverse events. Further research is needed to confirm the results obtained and to investigate the underlying causes for the observed outcomes. The scientific process is iterative, and the answers obtained from one study often lead to more questions and the need for additional investigations. Disclosure No.

(012) Incidence of Peyronie’s Disease After Radical Prostatectomy Among Patients Undergoing Penile Rehabilitation Regimen

Abstract Introduction Radical prostatectomy remains one of the gold standard treatments for localized prostate cancer, the most prevalent solid organ cancer in men. Surgical management of prostate cancer has been theorized to increase the risk of developing Peyronie’s Disease (PD). In 2010, Drs. Tal and Mulhall’s team characterized the incidence of PD in a cohort of 1011 men after radical prostatectomy to be 13.7% at 2 years and 15.9% at 3 years of follow-up. These numbers, significantly higher than estimates in the general population, which range from 0.5 to 7.1% (Sharma et al., Sex Med Rev 2020;8:314–23), suggest radical prostatectomy is a risk factor for developing PD. Objective Our aim was to evaluate the incidence of PD among post-prostatectomy patients who undergo a formal multi-modal penile rehabilitation program that includes mechanical and pharmacologic interventions to promote penile smooth muscle activation after surgery. Methods In this retrospective, descriptive study we reviewed the charts of 581 patients who were diagnosed with prostate cancer, treated with robot-assisted laparoscopic radical prostatectomy (RALP), and were engaged in a penile rehabilitation program from January 2016 through January 2019. At our institution, patients scheduled for prostatectomy are referred preoperatively to an academic Men’s Health clinic to start a multi-modal program and follow up regularly for evaluation of sexual health. The program includes daily tadalafil, L-citrulline, and VED use (Table 1). Patients refractory to these therapies had the option to increase tadalafil dosing or undergo further treatment with intracavernosal injections at ~3 months post-op. We excluded patients who had PD pre-operatively or who did not have post-operative follow-up with the providers at this institution. The primary outcome of interest was the incidence of PD among this cohort. Secondary outcome included time to development or diagnosis of PD. Results 581 patients with prostate cancer treated with RALP engaged in penile rehabilitation and were included in this analysis. The median age of men was 62.6 y with additional demographics listed in Table 2. The incidence of PD in this cohort was 2.9% (17 patients) with a median follow-up of 21.4 mo (IQR 2.8 – 55.8 mo). The diagnosis of PD was made at a median of 28.7 mo (IQR 20 – 36 mo) after prostatectomy. The 17 patients with PD had a median follow-up of 38.9 mo (IQR 23.2 – 55.8 mo). Conclusions In this cohort of prostate cancer patients treated with RALP and undergoing a consistent, multi-modal penile rehabilitation program, the incidence of PD was 2.9%, and median time to diagnosis was 28.7 months. This is the first study to assess PD incidence in men who engage in mechanical and pharmacologic penile rehabilitation at time of RALP. Furthermore, diagnosis of PD was made more than two years after surgery; this warrants further evaluation on whether penile rehabilitation prevents PD. This retrospective analysis is a hypothesis-generating study that should inspire further research on the role of regular mechanical stimulation or daily PDE-5 inhibitors in delaying or preventing PD after pelvic surgery. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo Scientific.

(016) Sexual Health Toxicity Following MRI-Guided versus CT-guided Prostate SBRT

Abstract Introduction Sexual health toxicities remain an under-reported but important health outcome for patients undergoing radiotherapy for localized prostate cancer. With the increasing adoption of higher daily doses of radiation over shorter timeframes delivered using stereotactic body radiotherapy (SBRT), the precision of radiation delivery remains an important factor that can reduce patient toxicity. MRI-guided SBRT (MRgRT) allows for improved image quality, treatment gating, and planning target volume margin reduction, offering improved radiation precision, which may translate to reduced treatment-related toxicity as compared to traditional CT-guided SBRT (CTgRT). Objective We sought to evaluate the effect of MRI-guidance on sexual health toxicity in patients following prostate SBRT for the treatment of localized prostate cancer. Methods We conducted a post-hoc analysis of patients enrolled on a phase III single-center randomized trial (MIRAGE: NCT04384770). The trial overall seeks to study the relative benefit of MRI vs CT guided SBRT (40 Gy/5 fractions) in patients with localized prostate cancer. Right and left neurovascular bundles (NVBs) and internal pudendal arteries (IPAs) were contoured on treatment planning images. Dosimetric parameters for these structures (Dmax, Dmin, Dmean, and V20Gy) were collected. Patient-reported sexual function outcomes (SHIM and EPIC-26 surveys) were also collected prior to treatment and at 1, 3, and 12 months following treatment. A clinically relevant decrement was defined as a ≥24 point decrease in the EPIC-26 sexual domain scores and a ≥9 point decrease on SHIM surveys. Unpaired t-tests and chi-square tests were used to evaluate for statistical significance. Results 152 patients received either MRgRT (n = 77) or CTgRT (n = 75). MRgRT resulted in a significant improvement in the volume receiving 20 Gy or less of radiation (V20Gy) in the left NVB (7.3cc vs 10.9cc, p = 4.4x10-8), right NVB (7.0cc vs 10.7cc, p = 2.8x10-7), and right IPA (0.42cc vs 1.35cc, p = 0.049), and trended towards significance for the left IPA (0.3cc vs 1.1cc, p = 0.066). Only 48 patients were not given hormonal therapy with radiotherapy. No statistically significant differences in clinically relevant decrements in patient-reported SHIM or EPIC scores were seen between MRgRT and CTgRT in these patients. No clear association between acute or chronic (12-months post-RT) sexual health toxicity and radiation exposure to the NVBs or IPAs was identified. Conclusions Patients treated with MRgRT had decreased radiation exposure to the bilateral NVBs and IPAs compared to patients treated with CTgRT. These data highlight the dosimetric benefits of MRgRT with regard to sexually relevant organs at risk. Power to detect associations between dosimetry and patient-reported sexual health outcomes will increase as the data matures and more patients have recovered testosterone after use of hormonal therapy. Future work will assess the impact on MRI-guided vs CT-guided radiation on sexual health outcomes at later time points. Disclosure No.

Racial and ethnic differences in the receipt of metabolic syndrome risk factor screening and treatment among individuals with prostate cancer treated with androgen deprivation therapy.

29 Background: Racial and ethnic health disparities in prostate cancer screening, and treatment constitute the largest of all cancer disparities. Androgen deprivation therapy (ADT) is widely used in the treatment of localized or metastatic prostate cancer. However, ADT is associated with toxic cardiovascular and metabolic adverse events that may occur as early as 6 months of therapy initiation. This study aimed to assess racial/ethnic differences and longitudinal changes in metabolic syndrome risk factor (MSRF) screening/treatment among patients with prostate cancer treated with ADT at a university-affiliated comprehensive cancer center in the southwestern U.S. between 2010-2021. We also aimed to identify patient and healthcare provider factors that influence MSRF screening among study sample. Methods: A retrospective observational cohort study of 803 patients treated with ADT for at least six months at the cancer center was conducted. Patients were followed three months pre- to 12 months post-ADT initiation to evaluate MSRF screening/treatment. Determination of MSRF screening was based on primary care provider referral for MSRF screening/treatment or receipt of blood glucose, lipid profile, and blood pressure screening within six months post-treatment with ADT. Patients were considered treated for MSRF if they were started or continued therapy (within six months of ADT initiation) with science advisory guideline recommended treatments. Results: Guideline-concordant MSRF screening rate approached 23.5%; MSRF treatment rate was 76.9%. A higher treatment rate in MSRF treatment was found for NHW compared to Hispanic men ( p=0.02). We found a significant difference in the proportion of patients receiving MSRF screening across all racial/ethnic groups ( p=0.03). MSRF screening rates from 13.9% to 35.6% were observed over the 10-year data collection period. Patients with dyslipidemia at baseline had higher odds of having MSRF screening than patients without dyslipidemia ( p&lt;0.0001). Oncologists with &gt;20 years of experience had higher odds of providing MSRF screening compared with &lt;10 years of experience ( p=0.006). Conclusions: Minority populations had significantly lower odds of having MSRF screening than NHW patients after adjusting for clinical and socio-economic variables. Closer clinical attention and education, as well as the development and implementation of innovative practice tools and interventions to optimize MSRF screening and treatment are warranted to mitigate the harmful adverse effects of ADT in patients with prostate cancer.