Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biops
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 co
| Condition(s) | Treatment-naive Prostate Cancer, Suspected Prostate Cancer, Molecular Imaging |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Patients with suspected prostate cancer and a PSA level ≥4.0 ng/mL 2. Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy 3. Patients who are willing to undergo prostate biopsy 4. Patients who provide written informed consent to participate in the study Exclusion Criteria: 1. Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan 2. Patients with a history of other malignancies within the past two years 3. Patients judged by the study investigator to be at risk for serious complications that could interfere with the normal conduct of the study |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | Xijing Hospital |
| Locations | Lanzhou, Gansu, China; Yinchuan, Ningxia, China; Xining, Qinghai, China; Weinan, Shaanxi, China; Xi'an, Shaanxi, China; Xi'an, Shaanxi, China (+3 more sites) |
| Start date | 2021-03-05 |
| NCT ID | NCT07531329 |
| Official listing | https://clinicaltrials.gov/study/NCT07531329 |