Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedOctober 5, 2020
September 1, 2020
8 months
September 28, 2020
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
detection rate
detection rate of csPCa
one year
Secondary Outcomes (1)
detection rate
one year
Eligibility Criteria
community residents
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 5, 2020
Study Start
July 1, 2020
Primary Completion
March 1, 2021
Study Completion
July 1, 2021
Last Updated
October 5, 2020
Record last verified: 2020-09