NCT05822726

The Combination of PSMA-PET/MR and p2PSA in Early Diagnosis of Prostate Cancer

The Combination of PSMA-PET/MRI and p2PSA in Early Diagnosis of Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a single center prospective non-randomized controlled study. The goal of this clinical trial is to figure out whether the combination of PSMA-PET/MR and PHI could add values to each method alone. The main questions it aims to answer are: * Compare the diagnostic value of the combination with each alone and set up a diagnostic model. * Compare the diagnostic value of PSMA-PET/MR+PHI to mpMRI+PHI. * Evaluate the diagnostic value the combination of PHI and PSMA-PET/MR in suspected PCA patients. Patients will experience mpMRI or PSMA-PET/MR and their blood samples will be used to test PSA and p2PSA. Prostate biopsy will be the golden standard.

Conditions

• Prostate Cancer
• PSMA
• p2PSA

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prostate biopsy	Targeted guided puncture biopsy guided by B-ultrasound will be performed (in addition to 12-needle system biopsy, if PSMA-PET/MRI or mpMRI indicates a positive lesion, puncture biopsy should be added at the lesion displayed on image, the "12-needle system biopsy+X" scheme).

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-09-30
• Completion: 2025-06-30
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

1 site across 1 country: China