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

Recruiting now

Conditions studied: Treatment-naive Prostate Cancer, Suspected Prostate Cancer, Molecular Imaging

In brief

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 optimal threshold for delayed SUVmax using ROC analysis with the Youden index; 2. Determine the optimal threshold for ΔSUVmax (delayed minus standard SUVmax); 3. Validate the sensitivity, specificity, and AUC of these thresholds in an independent validation set. 2. Biopsy avoidance potential In patients with PI RADS 4-5 lesions, calculate the negative predictive value (NPV) using a predefined high threshold to estimate the proportion who could safely avoid biopsy. 3. Diagnostic performance in key subgroups Compare the AUC of delayed SUVmax versus standard SUVmax for csPCa detection in patients with PI RADS 2-3 and in those with PI RADS 4-5. 4. Additional lesion detection Proportion of patients with additional csPCa lesions detected only on delayed imaging, and the proportion whose PI RADS category would be upgraded based on these findings. 5. Clinical decision impact Proportion of patients in whom management recommendations would change after incorporating delayed imaging results, compared with standard imaging alone. 6. Exploratory subgroup analyses Stratify by PSA level (\<4, 4 10, \>10 ng/mL) and PSA density (\<0.10, 0.10-0.20, \>0.20 ng/mL/cc) to identify subgroups that derive the greatest benefit from delayed imaging; additionally, explore combined subgroups such as PI RADS 3 with PSA 4-10 or PSAD 0.10-0.20. Inclusion Criteria 1. Suspected prostate cancer based on elevated PSA (≥4.0 ng/mL) or clinical symptoms 2. Undergo PSMA PET (standard + delayed) prior to prostate biopsy 3. Willing to undergo prostate biopsy 4. Provide written informed consent Exclusion Criteria 1\. Prior prostate cancer treatment before PSMA PET imaging 2. Other malignancy within past two years 3. Investigator-judged risk of serious complications interfering with study conduct

Key facts

Study ID: NCT07531329
Run by: Xijing Hospital
People needed: 1000
Starts: 2021-03-05
Expected to finish: 2028-03-05
Last updated by the study team: 2026-04-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients with suspected prostate cancer and a PSA level ≥4.0 ng/mL
Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy
Patients who are willing to undergo prostate biopsy
Patients who provide written informed consent to participate in the study

You may not qualify if…

Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan
Patients with a history of other malignancies within the past two years
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 is running

The First Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (enrolling)
Qinghai University Affiliated Hospital — Xining, Qinghai, China (enrolling)
Weinan Central Hospita — Weinan, Shaanxi, China (enrolling)
Xijing 986 Hospital — Xi'an, Shaanxi, China (enrolling)
Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (enrolling)
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang, Shaanxi, China (enrolling)
Affiliated Hospital of Yan'an University — Yan’an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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