PSMA-RGS (GR2018-12368369)
Description
Database for patients included in the prospective phase 2 study PSMA-RGS (GR2018-12368369). Data dictionary is included in the name of the variables and the coding is separated by an underscore. Enclosed you can also find a CSV file with the coding.
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The study cohort comprised patients diagnosed with localized PCa (cTanyN0M0 at conventional imaging) treated with Robot-Assisted Radical Prostatectomy (RARP) with a risk of lymph node invasion (LNI) ≥5% and candidates for an ePLND. All patients have been enrolled in a phase 2, single-institution, national, non-comparative, non-randomized, prospective study (NCT04832958) initiated in November 2020. The prospective trial was funded through a grant by the Italian Ministry of Health (Giovani Ricercatori GR2018-12368369). Surgery was performed by three high-volume surgeons who had performed more than 100 cases of RARP at the time of the study initiation. Main exclusion criteria include the receipt of neoadjuvant therapies, prior PCa treatments, or involvement in other experimental trials. Prior to surgery, patients underwent PSMA PET. Evaluation of all PSMA PET scans at our center was performed by experienced nuclear medicine physicians. Following approval from the Italian Medicines Agency, 99mTc-PSMA-I&S was prepared using a synthesis kit (piCHEM, Raaba-Grambach, Austria) and administered a day prior to RARP and ePLND (20 hours before surgery; median activity: 735 MBq). SPECT/CT imaging occurred 270 minutes after the administration of 99mTc-PSMA-I&S to document tracer uptake and served as a quality control. Positive findings on PSMA PET and 99mTc-PSMA-I&S PET/CT were defined as the presence of any uptake in the pelvic and/or retroperitoneal nodes.All surgeries were conducted via a transperitoneal approach utilizing the Da Vinci Xi system. A Drop-In gamma probe with C.E. marking (Crystal Drop-In Probe; Crystal Photonics, Berlin, Germany) was inserted through a 15-mm auxiliary port positioned above the right iliac crest. This gamma probe was employed for real-time intraoperative measurements to detect potential metastatic sites in the internal iliac, external iliac and obturatory regions. In case of suspicious preoperative imaging or in patients with very-high preoperative LNI risk (Briganti nomogram 2019 > 30%), intraoperative measurements using the Drop-In gamma probe was extended up to the common iliac (above the ureteric crossing), presacral, and retroperitoneal regions. A control unit provides both auditory and numerical feedback in response to 99mTc activity, aiding in intraoperative surgical guidance. As per-protocol indications, we initially defined a positive discovery as any lesion with a count rate at least twice that of the background reference, specifically, the fatty tissue covering the psoas muscle. Therefore, any positive lesions with a count rate exceeding double that of the background reference were surgically removed. After excision, ex-vivo gamma measurements were conducted to confirm the elimination of radioactive lesions or to prompt further investigation if a signal was absent. All excised tissues were categorized according to the anatomical site of removal. An anatomically defined ePLND was then carried out.
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Ministero della Salute
GR2018-12368369