Benign Prostatic Hyperplasia (BPH)

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

This research aims to evaluate whether adding a traditional Chinese medicine called Lingze tablets to the standard drug tamsulosin can better improve sleep quality and reduce nighttime urination problems in men who have undergone transurethral holmium laser enucleation of the prostate, a minimally invasive surgery for enlarged prostate. Many men continue to experience bothersome urinary symptoms and poor sleep after surgery, which can significantly affect their quality of life. This trial compares standard treatment to a combination approach to see if the addition of Lingze tablets offers added benefits. Participants will be randomly assigned to one of two groups. One group will take tamsulosin sustained-release capsules (0.2 mg) orally once daily at bedtime for 8 weeks. The other group will take the same tamsulosin dose plus Lingze tablets (4 tablets, three times daily) for 8 weeks. Lingze tablets are herbal-based and thought to support kidney function and clear bodily dampness and heat according to traditional Chinese medicine. Both groups will receive standard postoperative care guidance on diet, fluid intake, and activity. During the study, participants will visit the clinic at the start, 4 weeks, and 8 weeks for assessments. They will complete questionnaires on urinary symptoms, sleep quality, anxiety, and quality of life. Non-invasive urine flow tests and bladder ultrasounds will measure urinary function. Medication adherence and any side effects will be monitored. The primary outcome is the change in nighttime urination frequency over 8 weeks, with secondary outcomes including sleep quality and symptom severity. Safety and privacy are carefully maintained throughout the study.

This research aims to evaluate the safety and effectiveness of the FloStent, a medical device designed to treat men with symptoms of Benign Prostatic Hyperplasia (BPH). The study is a randomized, double-blind clinical trial comparing the FloStent to a sham procedure without device deployment. It focuses on men aged 45 years and older who experience urinary symptoms related to BPH. Participants will undergo a flexible cystoscopy procedure. Those assigned to the treatment group will receive the FloStent implant during this procedure, while those in the control group will have the cystoscopy without the implant being deployed. The study involves close monitoring over a 12-month period to assess changes in urinary symptoms. Throughout the study, participants will be evaluated using the International Prostate Symptom Score (IPSS) at various intervals, including 3, 6, and 12 months. This scoring system helps measure symptom changes over time. Researchers will also monitor safety and treatment responses. Participants can expect scheduled visits and assessments to track outcomes related to urinary function and device safety during the study duration.

Prostate cancer is the most common cancer among men in Denmark, often developing slowly without symptoms. This trial evaluates a complex intervention designed to improve how general practitioners (GPs) use prostate specific antigen (PSA) tests in line with national guidelines. The goal is to reduce overdiagnosis and overtreatment caused by unnecessary PSA testing, by promoting evidence-based practice among GPs in quality clusters. The intervention involves a cluster package including a pre-recorded podcast for GPs, a two-hour cluster meeting with educational material and group discussions, and two sets of hand-outs to support GPs in their clinics. Quality clusters are randomized to either receive this intervention over six months or act as a control group, which will be offered the intervention afterward. Participants, who are quality clusters of GPs, will be involved in cluster meetings and use the provided materials. Researchers will measure changes in PSA testing frequency among men during the six-month intervention period, as well as variations between GPs. The study includes assessments of PSA test use before and after the intervention to evaluate its impact on clinical practice.

This research aims to compare the safety and effectiveness of three different endoscopic techniques for removing large prostate tissue in men with benign prostatic hyperplasia (BPH) who experience severe urinary symptoms. The study focuses on men with prostate sizes over 100 mL who have not responded to medical treatments and have significant symptoms measured by the International Prostate Symptom Score (IPSS) and urinary flow rates. The trial is a prospective randomized controlled study conducted at Tanta University Hospital, evaluating three surgical methods used to treat large prostates causing lower urinary tract symptoms. Participants will be randomly assigned to one of three groups, each undergoing a different prostate enucleation procedure: Thulium Fiber Laser Enucleation (ThuFLEP) using a 60W thulium fiber laser, Holmium Laser Enucleation (HoLEP) using a 150W holmium YAG laser, or Bipolar Transurethral Enucleation (B-TUEP) using bipolar electrical energy. All procedures are performed transurethrally and involve removing the prostate tissue with a morcellator. Each group will have 30 patients, and the study will run from October 2025 to October 2027. Participants will undergo thorough preoperative assessments including symptom scores, urinary flow tests, ultrasounds, blood tests, and prostate-specific antigen measurements. After surgery, follow-ups at 1, 3, and 6 months will evaluate symptom relief, quality of life, urinary flow rate, residual urine volume, and erectile function. Researchers will also track operative times, blood loss, catheter duration, hospital stay, and complications categorized by the Clavien-Dindo system. The study measures both patient outcomes and surgical efficiency over six months post-operation.

This research aims to evaluate the Beacon Platform, a robotically assisted surgical device, for treating benign prostatic hyperplasia (BPH) in men. The study focuses on observing the outcomes of the Holmium Laser Enucleation of the Prostate (HoLEP) procedure using this platform. It is a prospective, multicenter, open-label pilot study designed to gather information on both intraoperative and postoperative results. Participants will undergo the HoLEP procedure assisted by the Beacon Platform, which allows the urologist to control surgical instruments through software during transurethral, endoscopic surgery. This single-arm study monitors the procedure without comparing to other treatments. The study tracks outcomes such as successful completion of the robot-assisted surgery without conversion and adverse events occurring up to 30 days after the procedure. During the study, participants will be closely monitored for safety and effectiveness through various assessments, including length of hospital stay, catheterization duration, operative time, and any complications such as perforations or damage requiring intervention. Researchers will also observe hospital readmissions related to genitourinary conditions within 30 days following the surgery. Participant involvement includes signing informed consent, undergoing the procedure, and completing follow-up evaluations until the study concludes.

Researchers are conducting an international, multicenter observational study to understand how patients admitted to hospitals with emergency haematuria are managed. The study aims to identify variations in care, measure outcomes like length of hospital stay, mortality, readmission rates, and resource use, and support the development of future guidelines and trials to improve haematuria management. The study collects detailed data on patient demographics, underlying health conditions, diagnostic procedures, treatments, and outcomes using a standardized form. It includes patients admitted as emergencies with haematuria under urology care. The study observes current hospital management pathways and gathers information through questionnaires to participating sites. Participants will be followed during their hospital stay and for 90 days afterward. Researchers will evaluate length of stay, time to diagnosis, mortality at 30 and 90 days, readmissions, days alive and out of hospital, and healthcare costs. The study uses data analysis to assess factors linked to outcomes and variations in care. Participation involves no changes to treatment as it is observational, and data will be collected consecutively over a 12-month period from multiple centers.

This clinical trial is focused on healthy adult male volunteers to evaluate the safety and pharmacokinetics of two drugs, AD-116 and AD-1161, under fed conditions. The study is a Phase 1, open-label, randomized, single-dose crossover trial aimed at understanding how these drugs behave in the body when taken with food. It specifically targets males aged 19 years and older who meet health criteria. Participants receive single doses of AD-116 or AD-1161 according to a randomized sequence in two study periods. In one sequence, the reference drug, Duodart capsule, is given first followed by the test drug AD-1161, which contains dutasteride 0.5 mg and tamsulosin 0.4 mg. In the other sequence, the order is reversed. Each drug is administered orally once during its respective period. During the trial, researchers measure drug concentration over time by tracking the area under the plasma concentration-time curve (AUCt) and the maximum concentration (Cmax) from pre-dose to 72 hours post-dose. Participants are monitored for safety and drug effects throughout the study. The total duration includes two dosing periods with assessments extending up to 72 hours after each dose to fully evaluate drug absorption and safety under fed conditions.

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points: before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.