TheranosticTrials.org

Clinical Trial · NCT05670691

a Study of Combined mpMRI and PSMA PET/CT for Highly Suspicious Patients Performing Radical Prostatectomy Without Biopsy

Overview

This is an observational, open, single-arm, prospective, staged entry（based on Fleming's Group-Sequential Design） clinical study The Goal is to evaluate the feasibility and clinical value of direct robot assisted laparoscopic radical prostatectomy without prostate biopsy in patients with high clinical suspicion of prostate cancer based on a prostate MRI PI-RADS score of ≥4 and the PSMA PET/CT positive criteria. The Primary endpoint is positive pathological diagnosis of prostate cancer after direct radical prostatectomy without prostate biopsy. The question addressed is whether the feasibility of biopsy-free radical prostatectomy could be scientifically and rationally derived based on Fleming's Group-Sequential design.

Sponsor

Fudan University

Contacts

Dingwei Ye, Doctor (STUDY_DIRECTOR)

Guowen Lin, doctor (CONTACT)

guowenlin@urocancer.org

86-021-6175590

ClinicalTrials.gov

NCT05670691

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • consent and ability to complete PSMA PET/CT.
  • consent and ability to complete a multiparametric MRI of the prostate.
  • the presence of pelvic lymph node enlargement (\>2 cm) or metastasis is allowed; ≤5 bone and lymph node metastases are allowed
  • Positive PSMA PET/CT. Its positive is defined as a suspicious lesion score of 2 or 3 (see remarks for specific scoring criteria).
  • multiparametric MRI of the prostate with a PI-RADS score of 4 or 5 for suspicious lesions.
  • no history of radiotherapy or other surgery to the pelvis
  • the patient is able to receive treatment and subsequent follow-up

Exclusion

  • unwillingness or inability to perform PSMA PET/CT; or PSMA PET/CT score of 0 or 1
  • More than 5 bone and lymph node metastases, visceral metastases
  • refusing radical prostate cancer surgery, or choosing other primary lesion treatment modalities other than radical prostate cancer surgery