Clinical Trial · NCT05587192

Radical Prostatectomy Without Prostate Biopsy Following PSMA PET/CT Based on Diagnostic Model

Overview

The goal of this prospective, single-center, single-arm trial is to evaluate the positive predictive values between 18F-PSMA-1007 PET/CT based on diagnostic model in patients with suspicious of prostate cancer. The main question and our aim to answer is: • Can these patients with clinically significant prostate cancer in 18F-PSMA-1007 PET/CT based on diagnostic model undergo radical prostatectomy directly without prostate biopsy. Participants will be asked to accomplish the test of serum PSA, mpMRI, then, the eligible patients (The probability of the diagnostic model to predict clinically significant prostate cancer was greater than or equal to 60 percent) need perform 18F-PSMA-1007 PET/CT. Finally, patients will receive radical prostatectomy directly if prostate cancer is considered by 18F-PSMA-1007 PET/CT.

Sponsor

Anhui Provincial Hospital

Phase

N/A

Contacts

Tao Tao, MD Ph.D (STUDY_CHAIR)

ClinicalTrials.gov

NCT05587192

Drug / Compound

PSMA-1007

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Complete the test of serum PSA and examination of mpMRI;
Men with clinically suspected prostate cancer (abnormal DRE or PSA);
4 ng/ml ≤serum total PSA\<100ng/ml;

Exclusion

Patients refuse radical prostatectomy or still choose prostate biopsy.
Prostate cancer is not considered by 18F-PSMA-1007 PET/CT;
The probability of the diagnostic model to predict clinically significant prostate cancer was less than 60 percent;