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

Prostatic Neoplasms Clinical Trial

Official title:

Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573179
• Other study ID #: AF/SQ-05/30
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2020
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Hongqian Guo
• Phone: 13605171690
• Email: dr.ghq[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
China	Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate	detection rate of csPCa	one year
Secondary	detection rate	detection rate of non-csPCa	one year