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Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer

Recruitingn/aAges 18 Years - anyMaleXijing Hospital
NCT07531329 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only Acquisition
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Where

9 sites
The First Hospital of Lanzhou University
Lanzhou, China
General Hospital of Ningxia Medical University
Yinchuan, China
Qinghai University Affiliated Hospital
Xining, China
Weinan Central Hospita
Weinan, China
Xijing 986 Hospital
Xi'an, China
Xijing Hospital
Xi'an, China
Shaanxi Provincial People's Hospital
Xi'an, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, China

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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