Delayed PSMA PET/CT to improve detection of significant prostate cancer before biopsy
Delayed PSMA PET/CT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer
This study tests whether adding a delayed (2–3 hour) PSMA PET/CT scan improves detection of clinically significant prostate cancer in treatment‑naïve men who are awaiting biopsy compared with the standard 60‑minute scan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 9 sites (Lanzhou, Gansu and 8 other locations) |
| Trial ID | NCT07531329 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men with suspected, treatment‑naïve prostate cancer (PSA ≥4.0 ng/mL) who are willing to undergo PSMA PET/CT including a delayed pelvic scan and subsequent prostate biopsy.
Not a fit: Patients who have already received prostate cancer treatment, have recent other malignancies, are medically unfit for biopsy, or cannot attend a delayed imaging session are unlikely to benefit.
Why it matters
Potential benefit: If successful, delayed imaging could increase detection of clinically significant cancers, reduce unclear scan results, and potentially lower unnecessary biopsies.
How similar studies have performed: Prior single‑center and retrospective studies have shown that delayed PSMA imaging can improve tumor‑to‑background contrast and reduce equivocal findings, but prospective multicenter validation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lanzhou, Gansu and 8 other locations
- 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)
Study contacts
- Study coordinator: Jianhua Jiao, MD.
- Email: 1531769428@qq.com
- Phone: +86 18700919857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.