Pathological Positivity Rate in Prostate Cancer Patients with PI-RADS 4 and First Negative Biopsy

Recruiting · NCT06677775 · Observational (researchers observe without assigning treatment) · Lead sponsor: Anhui Provincial Hospital

What this trial is about

The purpose of this prospective, single-center, single-arm trial was to evaluate the pathologic type of re-treatment based on a clear PI-RADS score of ≥4 with a first negative prostate biopsy, belonging to the high-risk group of the USTC diagnostic model, and PSMA PET/CT positive patients, and to evaluate the diagnostic efficacy of the USTC diagnostic model combined with PSMA PET/CT. At the same time, to explore whether these patients can directly undergo radical prostatectomy without repeated puncture. Firstly, patients with PI-RADS≥4 scores were screened and the first prostate biopsy was negative. Then USTC diagnostic model was used to evaluate the risk probability of patients suffering from csPCa to determine whether the patients belonged to the high-risk group. Then PSMA/PET-CT was improved for patients in high-risk group to identify the positive lesions of prostate. Finally, for patients with ≥4 PI-RADS and negative prostate aspiration for the first time, Laparoscopic radical prostatectomy (LRP) was performed compared with high-risk groups of USTC diagnostic model and positive PSMA PET/CT. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.

Who can take part

Where it is running

1 location listed.

• The First Affiliated Hospital of USTC - Hefei, Anhui, China