Brief Title: INTROSPECT: Intraoperative PSMA PET/CT Imaging During Radical Prostatectomy

During prostate cancer surgery, the surgeon aims to remove the tumor completely while preserving the surrounding tissue responsible for urinary continence and sexual potency. However, during surgery, it can be difficult to distinguish cancerous tissue from surrounding healthy tissue and therefore to determine the exact extent of the tumor. As a result, cancer cells may sometimes remain at the edge of the removed prostate, resulting in what is known as a positive surgical margin. Currently, positive surgical margins are identified by histopathology of the prostate specimen, with the results becoming available several days after surgery. The long-term goal of intraoperative imaging is to provide surgeons with information about tumor extent and surgical margins while the operation is still ongoing. This information could allow surgeons to remove additional cancerous tissue during the same procedure while helping preserve surrounding healthy structures. This pilot study INTROSPECT is an initial step toward this goal. INTROSPECT is a prospective pilot study at Geneva University Hospitals evaluating a PET/CT Scanner (AURA-10, Xeos Medical, Belgium) to analyze the prostate specimen directly in the operating room (results in 12 minutes). We plan to include 30 participants. All participants will receive an injection of a radiotracer (\[68Ga\]Ga-PSMA-11) at the beginning of surgery. Images will then be compared with the microscopic evaluation to find out how accurately they show the location and extent of the cancer. In this pilot study, the PET/CT findings will not be used to modify the surgical procedure or to remove additional tissue. The study is designed to determine whether the technique is sufficiently accurate and feasible to support future studies evaluating its use for real-time surgical decision-making. The study will also assess radiation exposure to operating room personnel and explore methods for interpreting and segmenting the PET images.

Inclusion Criteria: * Diagnosis of intermediate- or high-risk prostate cancer. * Preoperative PSMA PET staging with positive uptake in the primary tumor. * Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion. * Capacity to provide informed consent Exclusion Criteria: * Refusal to participate or withdrawal from the study. * Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia. * Participation in another clinical trial requiring ex vivo prostate tissue for research. * Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy. * Variant prostate cancer histology, such as neuroendocrine cancer. * Insufficient-quality or unavailable PSMA PET images, including corrupted data, or an incomplete histopathology report.