Gronau Westfalen

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the diagnostic performance of the radiopharmaceutical 18FPSMA-1007 PETCT imaging in patients newly diagnosed with high-risk or very-high-risk prostate cancer. This phase 3 study focuses on men with biopsy-proven, localized prostate adenocarcinoma who are candidates for curative prostatectomy and extended pelvic lymph node dissection. The goal is to compare the accuracy of 18FPSMA-1007 PETCT scans with histology results to detect pelvic nodal disease. Participants will receive a single intravenous dose of 18FPSMA-1007, followed by a PETCT scan to assess prostate cancer spread. Before the PETCT, participants must have had conventional imaging such as CT or MRI and bone scans if needed, within 60 days of the PETCT procedure. The study does not use blinding or placebo controls. Throughout the study, researchers will collect imaging data and compare PETCT findings to surgical histology obtained 6 to 8 weeks after surgery. Safety and diagnostic accuracy will be monitored. The study is expected to continue through September 2027. Participants will be closely evaluated during the imaging and surgery process, with follow-up to assess the detection of cancer involvement in pelvic lymph nodes.

Researchers are conducting a multicenter, randomized controlled trial to evaluate the effect of applying the polysaccharide agent ARISTA13 AH during robotic-assisted radical prostatectomy RARP for prostate cancer. The study aims to determine if this agent reduces postoperative blood loss by measuring hemoglobin levels after surgery. Additionally, the trial explores the impact on erectile function using the IIEF-5 score at 3, 6, and 12 months post-surgery. Participants will be randomly assigned to one of two groups one group will receive a 5g application of ARISTA13 AH to the prostate bed and neurovascular bundles during and at the end of surgery to control bleeding, while the other group will not receive this agent in these areas. No other hemostatic agents will be used in the treated areas. The surgery involves nerve-sparing techniques either unilaterally or bilaterally. Throughout the study, participants will be monitored for changes in hemoglobin levels from before surgery to 5-6 days afterward, as well as their erectile function at specified time points up to one year. Safety evaluations include monitoring for surgical complications and the integrity of the anastomosis. The total duration of participation includes the surgery and follow-up visits up to 12 months after RARP.