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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School60 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostatic Neoplasms

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * males over 18 years old suspected for prostate cancer * serum PSA between 4ng/ml and 20ng/ml in recent two months * mpMRI PI-RADS version2 scores 3 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 Exclusion Criteria: * history of prostate biopsy or other operations * history of prostate cancer associated treatment * 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)

Locations (1)

Outcomes

Primary Outcomes

detection rate

detection rate of csPCa

Time frame: one year

Secondary Outcomes