TheranosticTrials.org

Clinical Trial · NCT05822726

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

Overview

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.

Sponsor

Ruijin Hospital

Phase

N/A

ClinicalTrials.gov

NCT05822726

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Aged between 18 and 85 years;
  • Commit to complying with research procedures and cooperate in the implementation of the entire process of research.
  • 1. 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;
  • 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;

Exclusion

  • Previously diagnosed with prostate cancer
  • Taking 5a reductase inhibitors
  • Have had prostatitis (infectious or non infectious) 3 months before the examination
  • Have received any treatment (endocrine therapy, radiotherapy, chemotherapy, prostate resection, etc.)
  • 1. Preoperative clinical characteristics of suspected high-risk prostate cancer (according to NCCN guidelines): meet PSA\>20 ng/ml or clinical stage ≥ T3;