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Clinical Trials/NCT06209853
NCT06209853
Recruiting
Not Applicable

Correlation Between Prostate-Specific Antigen (PSA) Levels and Fluorine-18 Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography (F-18 PSMA PET/CT) Scan Findings in Patients With Prostate Cancer

Assiut University1 site in 1 country59 target enrollmentJanuary 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
Assiut University
Enrollment
59
Locations
1
Primary Endpoint
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

It is a cross sectional study aimed to correlate between PSA Levels and F-18 PSMA PET/CT Scan findings and to evaluate the impact of PET/CT findings on the patient management

Detailed Description

Prostate cancer (PC) is a prevalent malignancy that occurs primarily in old males, it is the third most common with regards of mortality (1,2). prostate-specific membrane antigen (PSMA) known as glutamate carboxypeptidase II, is a transmembrane glycoprotein highly expressed in PC cells. PSMA expression tends to increase with increased pathological Gleason grade and is thought to be upregulated with the emergence of androgen independence (2). PSMA PET/CT imaging is important for correct primary staging and for the detection of sites of biochemical recurrence. prostate-specific antigen Liu et al., in 2022 stated that as serum PSA levels increase, the diagnostic accuracy of F-PSMA-1007 PET/CT also improves (3) Bergero et al., in 2022 evaluated the diagnostic correlation between PSA and positivity of F-18 PSMA PET/CT in patients with biochemically recurrent prostate cancer (RPC), reporting it as a very good predictor of positivity in 18F-PSMA PET/CT in patients with RPC (4). A Meta-Analysis in 2022 found that the detection rate (DR) of the18F-PSMA-1007 PET/CT was also improved with increasing serum PSA levels (5) Another Meta-Analysis in 2019 studied the DR of F-18 PSMA PET/CT revealing that DR is related to PSA values with significant lower DR in patients with PSA\<0.5 ng/mL (6)

Registry
clinicaltrials.gov
Start Date
January 20, 2024
End Date
April 1, 2025
Last Updated
last year
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aalaa Wael Hussein

Assistant Lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications

Exclusion Criteria

  • Undifferentiated prostate cancer.
  • Studies with motion artifacts, or those in which patient can't stay stable or calm during acquisition.
  • Severely ill patients that hinder imaging.

Outcomes

Primary Outcomes

To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings

Time Frame: baseline

correlation between PSA Levels and F-18 PSMA PET/CT findings qualitatively \& quantitively interpreted by 2 nuclear medicine physicians. the Gleason score and findings of anatomical imaging (CT, MRI, ultrasound), will be obtained and compared/correlated with the PSMA expression/volumetric parameters as maximum standardized uptake value (SUV)

Secondary Outcomes

  • To evaluate the impact of PET/CT findings on the patient management(one year)

Study Sites (1)

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