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

NCT05822726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-04-21

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-09-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822726 on ClinicalTrials.gov