Gronau Westfalen

Researchers are evaluating the diagnostic performance of [18F]PSMA-1007 PET/CT imaging in men newly diagnosed with high-risk or very-high-risk prostate cancer. This phase 3 study focuses on patients with clinically localized prostate adenocarcinoma who are candidates for curative prostatectomy with extended pelvic lymph node dissection. The goal is to assess how well this imaging technique detects pelvic nodal disease compared to the standard histology reference after surgery. Participants will receive the diagnostic radiopharmaceutical [18F]PSMA-1007 for PET/CT scanning as part of the study. Conventional imaging such as CT or MRI, and bone scans if indicated, are performed within 60 days before the PET/CT procedure to detect pelvic nodal involvement and metastases. The study includes only men aged 18 years or older with newly diagnosed prostate cancer who have not received prior therapy for the disease. During the study, researchers will measure the sensitivity and specificity of the [18F]PSMA-1007 PET/CT in detecting pelvic nodal disease within 6 to 8 weeks after surgery. Participants will be monitored for safety and diagnostic outcomes. The study involves detailed assessments including imaging procedures, histology comparison, and clinical evaluations to understand the diagnostic accuracy of this PET/CT method in high-risk prostate cancer patients.

Researchers are evaluating the effects of applying a polysaccharide hemostatic agent called ARISTA™ AH during robotic-assisted radical prostatectomy (RARP) for localized prostate cancer. The study aims to see if this agent can reduce postoperative blood loss and improve erectile function compared to standard procedures. RARP is commonly used for prostate cancer but can cause blood loss and erectile dysfunction due to nerve injury. Lowering intraabdominal pressure during surgery may reduce complications like ileus but might increase bleeding, so this study explores a balance using ARISTA™ AH for better outcomes. Participants in this trial receive perioperative application of 5 grams of ARISTA™ AH to the prostate bed and neurovascular bundles during and at the end of surgery to control bleeding without using other hemostatic agents in that area. The approach includes intrafascial nerve-sparing surgery aiming to preserve nerve quality and minimize damage. The study compares postoperative hemoglobin levels and erectile function scores between the treated group and control to assess the agent's impact. During the study, participants are monitored for blood loss by measuring hemoglobin changes between the preoperative period and days 5 to 6 after surgery. Erectile function is evaluated using the International Index of Erectile Function (IIEF-5) at 3, 6, and 12 months post-surgery. Researchers also assess safety by tracking surgical complications and continence status. The total participation involves follow-up visits over one year to evaluate both blood loss and recovery of erectile function after RARP with ARISTA™ AH application.