Correlation Between PSA Levels and F-18 PSMA PET/CT Findings in Prostate Cancer Patient

Recruiting

• Conditions: Prostatic Neoplasms

• Registration Number: NCT06209853
• Lead Sponsor: Assiut University

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)

Study Timeline

• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-18
• Study Start: 2024-01-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 59

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings	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 Outcome Measures

Name	Time	Method
To evaluate the impact of PET/CT findings on the patient management	one year	determine dependency of PSA level in patient management in initial staging or biochemical recurrence

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt