Clinical Trial · NCT04573179

Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3

Overview

The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.

Sponsor

First Affiliated Hospital of Zhejiang University

Contacts

Hongqian Guo (CONTACT)

dr.ghq@nju.edu.cn

13605171690

ClinicalTrials.gov

NCT04573179

Drug / Compound

PSMA-11

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: HBED-CC

Eligibility

Inclusion

serum PSA between 4ng/ml and 20ng/ml in recent two months
willing to undertake prostate biopsy
no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride)
ECOG 0-1
mpMRI PI-RADS version2 scores 3 in recent two months

Exclusion

history of prostate biopsy or other operations
contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min)
not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)
history of prostate cancer associated treatment