Role of F-18 PSMA in Prostate Cancer Patient

Prostatic Neoplasms Clinical Trial

Official title:

Role of F-18 PSMA PET/CT in Patients With Prostate Cancer: Correlation Between Prostate-Specific Antigen Levels and PSMA PET/CT Scan Findings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06209853
• Other study ID #: F-18 PSMA in prostate cancer
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Aalaa W Hussein
• Phone: +201092855007
• Email: aalaawhy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Device:
• PSMA PET/CT
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Awenat S, Piccardo A, Carvoeiras P, Signore G, Giovanella L, Prior JO, Treglia G. Diagnostic Role of 18F-PSMA-1007 PET/CT in Prostate Cancer Staging: A Systematic Review. Diagnostics (Basel). 2021 Mar 19;11(3):552. doi: 10.3390/diagnostics11030552. — View Citation

Liu X, Jiang T, Gao C, Liu H, Sun Y, Zou Q, Tang R, Zeng W. Detection rate of fluorine-18 prostate-specific membrane antigen-1007 PET/CT for prostate cancer in primary staging and biochemical recurrence with different serum PSA levels: A systematic review and meta-analysis. Front Oncol. 2022 Jul 22;12:911146. doi: 10.3389/fonc.2022.911146. eCollection 2022. — View Citation

Liu X, Wang Q, Zhang B, Jiang T, Zeng W. Diagnostic accuracy of 18F-PSMA-1007 PET/CT for prostate cancer in primary staging and biochemical recurrence with different serum PSA levels: A systematic review and meta-analysis. Hell J Nucl Med. 2022 Jan-Apr;25(1):88-102. doi: 10.1967/s002449912438. Epub 2022 Apr 8. — View Citation

Tang DG. Understanding and targeting prostate cancer cell heterogeneity and plasticity. Semin Cancer Biol. 2022 Jul;82:68-93. doi: 10.1016/j.semcancer.2021.11.001. Epub 2021 Nov 26. — View Citation

Tsechelidis I, Vrachimis A. PSMA PET in Imaging Prostate Cancer. Front Oncol. 2022 Jan 28;12:831429. doi: 10.3389/fonc.2022.831429. eCollection 2022. — View Citation

Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings	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)	baseline
Secondary	To evaluate the impact of PET/CT findings on the patient management	determine dependency of PSA level in patient management in initial staging or biochemical recurrence	one year