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

Ruijin Hospital1 site in 1 country240 target enrollmentOctober 1, 2022

ConditionsProstate Cancer PSMA p2PSA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Ruijin Hospital
Enrollment: 240
Locations: 1
Primary Endpoint: biospy outcome
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

June 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Preoperative clinical judgment of suspected early prostate cancer (according to NCCN guidelines): meet PSA ≤ 20ng/ml and clinical stage\<T3, while meeting one of the following criteria:
•① Digital rectal examination revealed suspicious nodules of the prostate;
•② Transrectal prostate ultrasound or MRI found suspicious lesions;
•③ PSA\>10 ng/ml；
•④ PSA 4\~10ng/ml, f/t PSA suspicious or PSAD value suspicious;
•Aged between 18 and 85 years;
•Generally in good health, able to tolerate and cooperate with research interventions, such as prostate biopsy and radical prostatectomy Etc;
•Provide a signed and dated informed consent form;
•Commit to complying with research procedures and cooperate in the implementation of the entire process of research.

Exclusion Criteria

•Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA\>20 ng/ml or clinical stage ≥ T3;
•Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.)
•Have had prostatitis (infectious or non infectious) 3 months before the examination
•Taking 5a reductase inhibitors
•Previously diagnosed with prostate cancer
•In the acute infection period and fever period;
•Have a hypertensive crisis;
•In the period of decompensation due to cardiac insufficiency;
•Diseases with a tendency to severe bleeding;
•In diabetes, blood sugar is unstable;