Status:
UNKNOWN
Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Prostate Neoplasm
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This perspective cohort study aims to assess the detection rate of prostate cancer through prostate biopsy within suspicious patients harboring unfavorable multiparametric MRI but favorable 68Ga-PSMA ...
Detailed Description
Multiparametric MRI (MpMRI) is currently regarded as the best imaging method to noninvasively identify and characterize prostate cancer (PCa) with the Prostate Imaging Reporting and Data System (PI-RA...
Eligibility Criteria
Inclusion
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum prostate-specific antigen (PSA) \> 4 ng/ml within the previous 3 months;
- PI-RADS score no more than 3 or normal mpMRI of prostate;
- Suspicious lesion(s) within prostate on 68Ga-PSMA PET/MRI;
- no evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- Able to provide written informed consent.
Exclusion
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI or PET (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
- Contraindication to prostate biopsy.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04124107
Start Date
December 1 2019
End Date
December 1 2020
Last Update
October 14 2019
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