Delayed PSMA PET/CT to improve detection of significant prostate cancer before biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter diagnostic accuracy study enrolls treatment‑naïve men with suspected prostate cancer who undergo dual‑time‑point PSMA PET/CT (standard whole‑body at ~60 minutes and delayed pelvic imaging at 2–3 hours) before biopsy. Each patient serves as their own control and all participants receive systematic 12‑core biopsy plus targeted cores when indicated, with histopathology (ISUP grade group ≥2) as the reference standard for clinically significant disease. The primary outcome compares the AUC of delayed versus standard SUVmax for detecting clinically significant prostate cancer, and secondary outcomes include optimal SUV thresholds, negative predictive value and potential biopsy avoidance, detection of additional lesions on delayed imaging, and subgroup analyses by PI‑RADS. Imaging metrics and diagnostic thresholds will be internally validated across participating centers.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Jianhua Jiao, MD.
• Email: 1531769428@qq.com
• Phone: +86 18700919857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.