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

• Conditions: Prostatic Neoplasms

• Registration Number: NCT04573179
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection rate	one year	detection rate of csPCa

Secondary Outcome Measures

Name	Time	Method
detection rate	one year	detection rate of non-csPCa

Trial Locations

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China