An interventional study of multiparametric MRI and 68Ga-PSMA PET/MRI and Prostate biopsy in Prostate Neoplasm, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Status unknown. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Not applicable, Interventional, and Diagnostic
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.
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-RADS) v2. However, there are diagnostic difficulties for suspicious patients with PI-RADS score 3 and not all PCa are equivalently visible on mpMRI. For such patients, other alternative imaging techniques are required to properly characterize and detect PCa.
It has been widely reported that 68Ga-PSMA PET imaging offers excellent performance in detecting primary PCa and is able to noninvasively characterize the aggressiveness of PCa. Recently, integrated PET/MRI, which combines the strengths of both modalities, has been shown to have great potential for influencing clinical practice by providing a more certain map of localized PCa to aid targeted biopsies and therapy.
This perspective cohort study aims to assess the detection rate of PCa through prostate biopsy within suspicious patients harboring unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI who have had no prior prostate biopsy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
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Exclusion Criteria:
Both targeted biopsy and 12-core systematic biopsy with positive 68Ga-PSMA PET/MRI
Device: multiparametric MRI and 68Ga-PSMA PET/MRI · Procedure: Prostate biopsy
All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination
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
Detection rate of prostate cancer
Detection rate of prostate cancer
Time frame: 30 days post biopsy
Detection rates of clinically significant PCa and clinically insignificant prostate cancer
Detection rates of clinically significant PCa and clinically insignificant prostate cancer
Time frame: 30 days post biopsy
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology
Gleason grade group distribution (score from 1 to 5, the bigger the score, the worse the prognosis) and aggressive architecture (such as cribriform) on final pathology
Time frame: 90 days post biopsy
Optimal cut-off uptake value on PET/MRI for prostate cancer detection
Optimal cut-off uptake value on PET/MRI for prostate cancer detection
Time frame: 30 days post-biopsy
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School