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

NCT07531329 | Recruiting

• 1 other identifier: KY20262036-F-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 9

Brief 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 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. 1.Optimal diagnostic thresholds for delayed imaging
2. 2.Determine the optimal threshold for delayed SUVmax using ROC analysis with the Youden index;
3. 3.Determine the optimal threshold for ΔSUVmax (delayed minus standard SUVmax);
4. 4.Validate the sensitivity, specificity, and AUC of these thresholds in an independent validation set.
5. 5.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.
6. 6.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.
7. 7.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.
8. 8.Clinical decision impact Proportion of patients in whom management recommendations would change after incorporating delayed imaging results, compared with standard imaging alone.
9. 9.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.
10. 10.Suspected prostate cancer based on elevated PSA (≥4.0 ng/mL) or clinical symptoms
11. 11.Undergo PSMA PET (standard + delayed) prior to prostate biopsy
12. 12.Willing to undergo prostate biopsy
13. 13.Provide written informed consent Exclusion Criteria

Conditions

Treatment-naive Prostate Cancer; Suspected Prostate Cancer; Molecular Imaging

Keywords

Prostate Cancer; PSMA PET; Delayed imaging; Diagnostic; Efficacy

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Delayed SUVmax vs. Standard SUVmax for csPCa

  Compare the AUC of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (ISUP grade group ≥2) using the DeLong test , to determine whether delayed imaging is superior.

  [Time Frame: Baseline (comparison of standard vs. delayed images)]

Secondary Outcomes (9)

• Optimal Threshold of Delayed SUVmax for csPCa

  Baseline

• Optimal Threshold of ΔSUVmax (Delayed Minus Standard) for csPCa

  Baseline

• Diagnostic Performance of Optimal Thresholds in Validation Cohort

  Baseline

• Negative Predictive Value for Biopsy Avoidance in PI-RADS 4-5 Patients

  Baseline

• AUC of Delayed vs. Standard Imaging in PI-RADS 2-3 and PI-RADS 4-5 Subgroups

  Baseline

Study Arms (1)

Study Cohort

All enrolled patients with suspected prostate cancer undergo both standard and delayed PSMA PET imaging. Each patient serves as their own control, with diagnostic performance compared between the standard imaging phase and the delayed imaging phase.

Diagnostic Test: [⁶⁸Ga]Ga-PSMA PET/CT with Delayed Pelvic PET-Only Acquisition

Interventions

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

All enrolled patients undergo a dual-phase PSMA PET/CT imaging protocol consisting of: (1) a standard whole-body PET/CT acquisition performed at approximately 60 minutes after intravenous administration of \[⁶⁸Ga\]Ga-PSMA-11; and (2) a delayed pelvic PET acquisition performed at approximately 2-3 hours post-injection (exact timing to be standardized across participating centers based on local protocols and clinical workflow). The delayed phase does not include a separate CT scan; images are reconstructed using the CT dataset obtained from the initial whole-body acquisition for attenuation correction.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a consecutive series of patients with suspected prostate cancer based on elevated PSA levels (≥4.0 ng/mL) who are referred for initial diagnostic evaluation at participating centers. All enrolled patients undergo dual-phase \[⁶⁸Ga\]Ga-PSMA-11 PET/CT imaging (standard whole-body acquisition at approximately 60 minutes post-injection, followed by delayed pelvic PET acquisition at approximately 2-3 hours post-injection) prior to transrectal or transperineal prostate biopsy. Eligible patients must have no prior history of prostate cancer-related treatment and no other active malignancy within the past two years. This prospective cohort represents a typical diagnostic population in whom the incremental value of delayed PSMA PET imaging for prostate cancer detection is being investigated.

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

Sponsors & Collaborators

• Xijing Hospital: lead
• Air Force Military Medical University, China: collaborator
• National Translational Science Center for Molecular Medicine: collaborator
• Shaanxi Provincial People's Hospital: collaborator
• Weinan Central Hospital: collaborator
• Yan'an University Affiliated Hospital: collaborator
• The Second Affiliated Hospital of Shaanxi University of Chinese Medicine: collaborator
• LanZhou University: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• General Hospital of Ningxia Medical University: collaborator

Study Sites (9)

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, 710032, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710032, 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

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jianhua Jiao, MD.

CONTACT

+86 18700919857; 1531769428@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 15, 2026
• Study Start: March 5, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 5, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)