Condition: Treatment-naive Prostate Cancer · Suspected Prostate Cancer · Molecular Imaging · Sponsor: Xijing Hospital
Brief Summary This prospective, multicenter study evaluates whether delayed PSMA PET imaging improves diagnostic efficacy for detecting clinically significant prostate cancer (Gleason score ≥7) compared with standard imaging in patients with suspected newly diagnosed prostate cancer. Each patient serves as their own control, with diagnostic performance compared between standard (60-minute) and delayed (2-3 hour) acquisitions. Background PSMA PET has transformed prostate cancer imaging, with emerging evidence suggesting delayed acquisition may further improve diagnostic accuracy by increasing tumor-to-background ratio. Recent studies demonstrate that delayed imaging significantly reduces equivocal findings and enhances detection of clinically significant prostate cancer. Need While standard PSMA PET is well-validated, prospective multicenter data specifically evaluating the incremental diagnostic value of delayed imaging for clinically significant prostate cancer in treatment-naïve patients are lacking. This study addresses this gap by systematically comparing standard and delayed imaging in a large, well-defined cohort. Primary Outcome The primary outcome is to compare the area under the curve (AUC) of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (csPCa), and to determine whether delayed imaging is superior to standard imaging. Secondary Outcomes 1. Optimal diagnostic thresholds for delayed imaging 1. Determine the optima…
This description comes directly from the study's public registry record.
Jianhua Jiao, MD. · +86 18700919857 · 1531769428@qq.com
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| The First Hospital of Lanzhou University | Lanzhou, Gansu, China | Recruiting |
| General Hospital of Ningxia Medical University | Yinchuan, Ningxia, China | Recruiting |
| Qinghai University Affiliated Hospital | Xining, Qinghai, China | Recruiting |
| Weinan Central Hospita | Weinan, Shaanxi, China | Recruiting |
| Xijing 986 Hospital | Xi'an, Shaanxi, China | Recruiting |
| Xijing Hospital | Xi'an, Shaanxi, China | Recruiting |
| Shaanxi Provincial People's Hospital | Xi'an, Shaanxi, China | Recruiting |
| The Second Affiliated Hospital of Shaanxi University of Chinese Medicine | Xianyang, Shaanxi, China | Recruiting |
| Affiliated Hospital of Yan'an University | Yan’an, Shaanxi, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07531329