OBJECTIVE: SABR-Dual is a phase III trial with an initial phase-I safety cohort, of two-fraction stereotactic radiotherapy (SABR) with optional MRI-based focal boost, using peri-rectal spacing, for localized prostate cancer. This represents the initial report from the phase-I non-randomized cohort.
METHODS: Subjects had favorable intermediate risk (FIR) or low risk (LR) prostate adenocarcinoma, and gland volume <80cc. All underwent radiopaque hydrogel spacer and fiducial marker placement prior to simulation (CT and 3-tesla T2 MRI). The clinical target volume included the entire prostate, and in FIR patients, 1-2cm of seminal vesicle (SV). A 2mm expansion was applied for planning target volume (PTV), and a dose of 27 Gy was prescribed to the PTV-prostate, 23 Gy to the PTV-SV, with an optional 30 Gy simultaneous boost (SIB) to an MRI-defined dominant lesion. Primary endpoint was 3-month patient-reported changes in quality of life based on the EPIC-26, IPSS, and SHIM questionnaires. Secondary endpoints were 6-month quality of life, acute toxicity (using CTCAEv5) and early PSA response.
RESULTS: Among the 20 patients in the phase-I cohort, 95% had FIR disease, and 50% received an SIB. At median follow-up of 8 months, a 3-month minimally clinically important change occurred in 1/20 (5%), 6/20 (30%), 2/20 (10%), 4/20 (20%), and 5/20 (25%) in urinary incontinence, urinary obstructive, bowel, sexual, and hormonal domains. There was a mean increase of 1±5.4 in IPSS and decrease of 1.8±6.5 in SHIM scores. Rates of grade 2 urinary and bowel toxicity 10% and 0%, respectively, with no grade ≥3 toxicities. Mean PSA decrease at last follow-up was 70.4%±17.7%.
CONCLUSIONS: This generalizable protocol of two-fraction prostate SABR using peri-rectal spacing is a safe approach for ultra-hypofractionated dose-escalation, with minimal acute toxicity. Longer-term outcomes and direct comparison with standard 5-fraction SABR are being studied in the phase-III randomized portion of SABR-Dual.

BACKGROUND: Radical prostatectomy (RP) is a treatment method for prostate cancer (PCa). However, patients usually experience urinary incontinence and a reduction in quality of life after surgery. Seeking a nursing programme is necessary to improve the prognosis of patients undergoing RP. This study aims to explore the effect of the cluster nursing through empowerment education on patients with RP.
METHODS: The general data of 203 patients who underwent RP surgery from June 2021 to June 2023 were collected for a retrospective study. After excluding four patients who changed from RP to laparotomy during surgery, four patients with incomplete clinical data and three patients without normal communication ability, the remaining 192 patients were included in the study. The patients were divided into two groups in accordance with different nursing plans. In this study, 98 patients receiving the cluster nursing through empowerment education were set as the observation group (OG), and 94 patients undergoing routine nursing were included in the reference group (RG). The indicators of postoperative recovery, mental health status and life coping ability were compared between the two groups.
RESULTS: The times to first exhaustion, to start eating, of first off-bed activity and of hospitalisation in the OG were shorter than those in the RG (p < 0.001). No significant difference was found in the total incidence of complications between the two groups (p > 0.05). Before management, no significant difference in the scores of Hospital Anxiety and Depression Scale (HADS) and Activity of Daily Living Scale (ADL) was observed between the OG and RG (p > 0.05). After management, the HADS and ADL scores of the two groups all decreased, and the OG showed a greater reduction in scores than the RG (p < 0.001).
CONCLUSIONS: The cluster nursing through empowerment education can shorten the recovery time of patients after RP surgery and improve their living ability. This effect is beneficial to their mental health and can provide additional directions for the formulation of subsequent clinical nursing programmes.

BACKGROUND: Many people struggle with the choice in a series of processes, from prostate cancer (PCa) diagnosis to treatment. We investigated the degree of regret after the prostate biopsy (PBx) and relevant factors in patients recommended for biopsy for suspected PCa.
METHODS: From 06/2020 to 05/2022, 198 people who performed PBx at three institutions were enrolled and analyzed through a questionnaire before and after biopsy. Before the biopsy, a questionnaire was conducted to evaluate the sociodemographic information, anxiety scale, and health literacy, and after PBx, another questionnaire was conducted to evaluate the decision regret scale. For patients diagnosed as PCa after biopsy, a questionnaire was conducted when additional tests were performed at PCa staging work-up.
RESULTS: 190 patients answered the questionnaire before and after PBx. The mean age was 66.2 ± 7.8 years. Overall, 5.5% of men regretted biopsy, but there was no significant difference between groups according to the PCa presence. Multivariate analysis, to identify predictors for regret, revealed that the case when physicians did not properly explain what the prostate-specific antigen (PSA) test was like and what PSA elevation means (OR 20.57, [95% CI 2.45-172.70], p = 0.005), low media literacy (OR 10.01, [95% CI 1.09-92.29], p = 0.042), and when nobody to rely on (OR 8.49, [95% CI 1.66-43.34], p = 0.010) were significantly related.
CONCLUSIONS: Overall regret related to PBx was low. Decision regret was more significantly related to media literacy rather than to educational level. For patients with relatively low media literacy and fewer people to rely on in case of serious diseases, more careful attention and counseling on PBx, including a well-informed explanation on PSA test, is helpful.

OBJECTIVE: Benign prostatic hyperplasia (BPH) is a common urological condition affecting aging men worldwide. Among the treatment options available for BPH, transurethral resection of the prostate (TURP) is the gold-standard invasive intervention. To reduce the TURP-related non-negligible morbidity, loss-of-ejaculation rate, hospitalization, blood loss and catheterization time several laser techniques have been developed, such as the Thulium Laser Enucleation of the Prostate (ThuLEP). To investigate the efficacy outcomes of the ThuLEP as a treatment option for benign prostatic hyperplasia (BPH) we performed a retrospective observational study at Moriggia Pelascini Hospital (Como, Italy) between January 2015 and September 2018.
METHODS: We included 265 patients who underwent ThuLEP at a specific hospital between defined dates. Data on various parameters, including post-void residue volume, peak urinary flow rate (Qmax), International Prostate Symptom Score (IPSS) for urinary symptoms, IPSS Quality of Life (QoL) score, and International Index of Erectile Function (IIEF) score for erectile dysfunction, were collected at baseline and follow-up.
RESULTS: The analysis revealed significant improvements in voiding efficiency, urinary flow, urinary symptoms, quality of life, and erectile function following ThuLEP. Furthermore, certain baseline characteristics, such as post-void residue, peak urinary flow rate, age, prostate volume, and aspirin usage, were found to influence treatment outcomes.
CONCLUSIONS: Despite the study\'s limitations, these findings contribute to understanding ThuLEP\'s effectiveness in managing BPH and can aid in making informed clinical decisions for patient care. Prospective studies with longer follow-up periods are recommended to validate and extend these results.

UNASSIGNED: We aimed to establish if stereotactic body radiotherapy to the prostate can be delivered safely using reduced clinical target volume (CTV) to planning target volume (PTV) margins on the 1.5T MR-Linac (MRL) (Elekta, Stockholm, Sweden), in the absence of gating.
UNASSIGNED: Cine images taken in 3 orthogonal planes during the delivery of prostate SBRT with 36.25 Gray (Gy) in 5 fractions on the MRL were analysed. Using the data from 20 patients, the percentage of radiotherapy (RT) delivery time where the prostate position moved beyond 1, 2, 3, 4 and 5 mm in the left-right (LR), superior-inferior (SI), anterior-posterior (AP) and any direction was calculated.
UNASSIGNED: The prostate moved less than 3 mm in any direction for 90% of the monitoring period in 95% of patients. On a per-fraction basis, 93% of fractions displayed motion in all directions within 3 mm for 90% of the fraction delivery time. Recurring motion patterns were observed showing that the prostate moved with shallow drift (most common), transient excursions and persistent excursions during treatment.
UNASSIGNED: A 3 mm CTV-PTV margin is safe to use for the treatment of 5 fraction prostate SBRT on the MRL, without gating. In the context of gating this work suggests that treatment time will not be extensively lengthened when an appropriate gating window is applied.

UNASSIGNED: This study aimed to verify the feasibility and short-term prognosis of prostatectomy without biopsy.
UNASSIGNED: Patients with a rising PSA level ranging from 4 to 30 ng/mL were scheduled for multiparametric (mp) MRI and 18F-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Forty-seven patients (cT2N0M0) with Prostate Imaging Reporting and Data System ≥ 4 and molecular imaging PSMA score ≥ 2 were enrolled. All candidates underwent robot-assisted laparoscopic radical prostatectomy without biopsy. Prostate cancer detection rate, index tumors localization correspondence rate, positive surgical margin, complications, postoperative hospital stay, and PSA level in a 6-week postoperative follow-up visit were collected.
UNASSIGNED: All the patients with positive mpMRI and PSMA PET were diagnosed with clinically significant prostate cancer. A total of 80 lesions were verified as cancer by pathology, of which 63 cancer lesions were clinically significant prostate cancer. Fifty-one lesions were simultaneously found by mpMRI and PSMA PET. A total of 23 lesions were invisible on either image, and all lesions were ≤ International Society of Urological Pathology 2 or ≤ 15 mm. Forty-five (95.7%) index tumors found by mpMRI combined with PSMA PET were consistent with pathology. Nine patients reported positive surgical margin.
UNASSIGNED: Biopsy-free prostatectomy is safe and feasible for patients with evaluation strictly by mpMRI combined with 18F-PSMA PET/CT.

BACKGROUND: The TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures in terms of detection of clinically significant prostate cancer (PCa). This article describes the statistical analysis plan (SAP) for the TRANSLATE randomised controlled trial (RCT).
METHODS: TRANSLATE is a parallel, superiority, multicentre RCT. Biopsy-naïve men aged ≥ 18 years requiring a prostate biopsy for suspicion of possible PCa are randomised (computer-generated 1:1 allocation ratio) to one of two biopsy procedures: transrectal (TRUS) or local anaesthetic transperineal (LATP) biopsy. The primary outcome is the difference in detection rates of clinically significant PCa (defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease) between the two biopsy procedures. Secondary outcome measures are th eProBE questionnaire (Perception Part and General Symptoms) and International Index of Erectile Function (IIEF, Domain A) scores, International Prostate Symptom Score (IPSS) values, EQ-5D-5L scores, resource use, infection rates, complications, and serious adverse events. We describe in detail the sample size calculation, statistical models used for the analysis, handling of missing data, and planned sensitivity and subgroup analyses. This SAP was pre-specified, written and submitted without prior knowledge of the trial results.
CONCLUSIONS: Publication of the TRANSLATE trial SAP aims to increase the transparency of the data analysis and reduce the risk of outcome reporting bias. Any deviations from the current SAP will be described and justified in the final study report and results publication.
BACKGROUND: International Standard Randomised Controlled Trial Number ISRCTN98159689, registered on 28 January 2021 and registered on the ClinicalTrials.gov (NCT05179694) trials registry.

BACKGROUND: This study evaluates the efficacy of a nomogram for predicting the pathology upgrade of apical prostate cancer (PCa).
METHODS: A total of 754 eligible patients were diagnosed with apical PCa through combined systematic and magnetic resonance imaging (MRI)-targeted prostate biopsy followed by radical prostatectomy (RP) were retrospectively identified from two hospitals (training: 754, internal validation: 182, internal-external validation: 148). A nomogram for the identification of apical tumors in high-risk pathology upgrades through comparing the results of biopsy and RP was established incorporating statistically significant risk factors based on univariable and multivariable logistic regression. The nomogram\'s performance was assessed via the receiver operating characteristic (ROC) curve, calibration plots, and decision curve analysis (DCA).
RESULTS: Univariable and multivariable analysis identified age, targeted biopsy, number of targeted cores, TNM stage, and the prostate imaging-reporting and data system score as significant predictors of apical tumor pathological progression. Our nomogram, based on these variables, demonstrated ROC curves for pathology upgrade with values of 0.883 (95% CI, 0.847-0.929), 0.865 (95% CI, 0.790-0.945), and 0.840 (95% CI, 0.742-0.904) for the training, internal validation and internal-external validation cohorts respectively. Calibration curves showed good consistency between the predicted and actual outcomes. The validation groups also showed great generalizability with the calibration curves. DCA results also demonstrated excellent performance for our nomogram with positive benefit across a threshold probability range of 0-0.9 for the training and internal validation group, and 0-0.6 for the internal-external validation group.
CONCLUSIONS: The nomogram, integrating clinical, radiological, and pathological data, effectively predicts the risk of pathology upgrade in apical PCa tumors. It holds significant potential to guide clinicians in optimizing the surgical management of these patients.

BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) followed by MRI-targeted prostate biopsy is the current standard for diagnosing prostate cancer (PCa). However, studies evaluating the value of biomarkers, including prostate health index (PHI) and its derivatives using this method are limited. We aimed to investigate the efficacy of PHI density (PHID) in guiding MRI-targeted prostate biopsies to identify clinically significant PCas (csPCa).
METHODS: The multicenter prospectively registered prostate biopsy database from three medical centers in Taiwan included patients with PHI and MRI-targeted and/or systematic prostate biopsies. We assessed the required values of prostate-specific antigen (PSA), prostate volume, PHI, PHID, and Prostate Imaging Reporting & Data System (PI-RADS) score using multivariable analyses, receiver operating characteristic curve analysis, and decision curve analyses (DCA). csPCa was defined as the International Society of Urological Pathology Gleason group ≥2 PCa, with an emphasis on reducing unwarranted biopsies.
RESULTS: The study cohort comprised 420 individuals. Diagnoses of PCa and csPCa were confirmed in 62.4% and 47.9% of the participants, respectively. The csPCa diagnosis rates were increased with increasing PI-RADS scores (20.5%, 44.2%, and 73.1% for scores 3, 4, and 5, respectively). Independent predictors for csPCa detection included PHI, prostate volume, and PI-RADS scores of 4 and 5 in multivariable analyses. The area under the curve (AUC) for csPCa of PHID (0.815) or PHI (0.788) was superior to that of PSA density (0.746) and PSA (0.635) in the entire cohort, and the superiority of PHID (0.758) was observed in PI-RADS 3 lesions. DCA revealed that PHID achieved the best net clinical benefit in PI-RADS 3-5 and 4/5 cases. Among PI-RADS 3 lesions, cutoff values of PHID 0.70 and 0.43 could eliminate 51.8% and 30.4% of omitted biopsies, respectively.
CONCLUSIONS: PHI-derived biomarkers, including PHID, performed better than other PSA-derived biomarkers in diagnosing PCa in MRI-detected lesions.

UNASSIGNED: Anatomical endoscopic enucleation of the prostate (AEEP) provides durable management for patients with lower urinary tract symptoms (LUTS) secondary to large-sized prostate over other surgical modalities. We aimed to assess the early outcomes of Collins knife-assisted bipolar enucleation (BipolEP) versus Thulium-Yag enucleation (ThuLEP) in a group of patients with LUTS secondary to a prostate larger than 80 grams.
UNASSIGNED: We included patients with benign prostatic hyperplasia (BPH) having a prostate volume > 80 grams, international prostate symptom score (IPSS) >7, urine flow (Q-max) <15, and post-void residual (PVR)>150 ml. We excluded those with a history of previous prostatic surgery, stone, or neurogenic bladder. Bipolar enucleation with early apical release was performed using Collins knife at an 80/100-watt setting (Lamidey Noury), while ThuLEP was conducted using 550- micron fiber and 40/15-watt energy (Lisa Laser). Patients were evaluated before then 2 weeks and 3, 6,12 months postoperatively for changes in IPSS, Q- max, PVR, and the incidence of stress incontinence.
UNASSIGNED: One hundred and twenty patients were equally randomized with a mean prostate size of 104 ± 25 gram. The mean IPSS score was 25 ± 6, Qmax 7.6 ± 1.3 mL/S, and PVR 225 ± 39. There was no significant difference regarding enucleation time, morcellation time, and enucleated tissue volume. Irrigation volume and post-operative hemoglobin drop were significantly lower in the bipolar group (p = 0.008, p = 0.0002), respectively. At the third-month follow-up, IPSS, Q-max, and PVR were comparable across both groups, with stress incontinence at 3.3% in the bipolar group versus 1.6% in the thulium group, showing an insignificant difference (p = 0.5).\"
UNASSIGNED: Both BipolEP and ThuLEP, with early apical release, provide a safe and effective management of large-size prostate resulting in significant decrease in post-operative stress incontinence incidence during early follow-up. Intraoperative irrigation saline volume, and post-operative hemoglobin drop favored the bipolar group.