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

Nanjing University

Status: Unknown

Conditions: Prostatic Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT04573179

AF/SQ-05/30

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)