Clinical Research Directory

Collection of Blood From Patients With Prostate Cancer

Background: * It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role. * Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene. * Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others. Objectives: -To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state. Eligibility: -All participants participating in NCI prostate cancer protocols. Design: * Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic. * Blood samples are collected at the initial visit or at follow-up visits. * DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines. * Gene variations are correlated with prostate cancer prognosis and prognostic indicators.

Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.

Dose Escalation Study Evaluating Safety of TheraSphere Prostate Cancer (PCa) Device

The VOYAGER Study is an interventional, non-randomized, single-arm, dose escalation trial with the goal of determining the safety of TheraSphere PCa device in patients with clinically localized prostate cancer across US-based centers.

Feasibility of Suprapubic Transvesical Endoscopic Prostatectomy

In patients with penile prosthesis, any transurethral procedure could place the implant at risk. The use of long or extra-long resectoscope can be of some assistance; however, these are not available in many institutions. So suprapubic transvesical endoscopic prostatectomy is newly developed to bypass the anterior urethra. Thus, the aim of this study is to determine safety and efficacy of Suprapubic Transvesical endoscopic prostatectomy.

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions

The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.

Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate

The aim of this study is to compare between accuracy of lung US and IVC CI for early prediction of volume overload during TURP. Primary outcome: The incidence of volume overload during transurethral resection of prostate.

AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.

Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study

A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.

Enhanced Recovery After Urologic Surgery

This clinical trial aims to investigate the analgesic efficacy of several perioperative pain management strategies-specifically, epidural analgesia, paravertebral blockade, transversus abdominis plane (TAP) block, intravenous patient-controlled analgesia (PCA), and intrathecal morphine-in patients undergoing a range of urological procedures. These procedures include pediatric circumcision, hydrocelectomy, inguinal hernia repair, renal cyst excision, and transurethral resection of the prostate. The trial will also evaluate the safety profiles of two specific local anesthetics, liposomal bupivacaine and ropivacaine. The primary research question is whether these different analgesic techniques reduce postoperative opioid requirements in patients undergoing urological surgery. A secondary question explores the adverse events associated with the use of liposomal bupivacaine and ropivacaine in this population. Participants will be: Urological surgery patients undergoing one of the aforementioned procedures. These participants will be randomized to receive one of the following pain management modalities: epidural analgesia, paravertebral blockade, TAP block, intravenous PCA, or intrathecal morphine. Patient assessments will be conducted in the post-anesthesia care unit (PACU) and at 2, 6, 12, and 24 hours postoperatively. Outcome measures will include: Numeric Rating Scale (NRS) pain scores, total postoperative analgesic consumption, recovery status, patient satisfaction, and time to return of bowel function.

Focal Therapy in Localized Prostate Cancer: a Prospective Registry

The principal aim of the registry is to collect data on focal therapy (FT) for the treatment of intermediate-risk prostate cancer across Europe. Data will be gathered on cancer absence following treatment, survival rates, and the absence of disease failure or progression. Information will be collected from as many centers as possible over the next 5 years to enhance understanding of when focal therapy should be used, which energy types are most effective, and how patients respond to treatment, including its side effects and impact on quality of life. This Europe-wide data collection will contribute to improving care by informing the development of enhanced national and international guidelines for prostate cancer treatment with focal therapy.