Unfavorable MRI But Favorable 68Ga-PSMA PET/MRI for Primary Prostate Cancer Detection
NCT04124107 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-10-14
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 PET/MRI who have had no prior prostate biopsy.
Conditions
- Prostate Neoplasm
Interventions
- DEVICE
-
multiparametric MRI and 68Ga-PSMA PET/MRI
All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination
- PROCEDURE
-
Prostate biopsy
Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy
Sponsors & Collaborators
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
lead OTHER
Principal Investigators
-
Hongqian Guo, PhD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-31
- Primary Completion
- 2020-11-30
- Completion
- 2020-12-31
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