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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06209853
Enrollment
59
Registered
2024-01-18
Start date
2024-01-20
Completion date
2025-04-01
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

Keywords

PSMA PET/CT, Prostate, PSA

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)

Interventions

Patients need no specific preparation. F-18 PSMA dose will be 3-4 MBq/kg and injected via IV route scan will be performed 90-120 min after injection

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findingsbaselinecorrelation 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

MeasureTime frameDescription
To evaluate the impact of PET/CT findings on the patient managementone yeardetermine dependency of PSA level in patient management in initial staging or biochemical recurrence

Countries

Egypt

Contacts

Primary ContactAalaa W Hussein, master
aalaawhy@gmail.com+201092855007
Backup ContactNadia M Moustafa, PhD degree
drnadia1980@gmail.com01125006468

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026