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

NCT06209853 | Recruiting

• 1 other identifier: F-18 PSMA in prostate cancer
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Prostatic Neoplasms

Keywords

PSMA PET/CT, Prostate, PSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the impact of PET/CT findings on the patient management

  one year

Interventions

PSMA PET/CT DEVICE

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

Eligibility Criteria

• Gender Eligibility Details: male patients with prostate cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit patients with proven prostate cancer who will be referred to the nuclear medicine unit to perform F18-PSMA PET/CT study for initial staging, restaging, evaluation of biochemical recurrence, or follow up

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 35155262 BACKGROUND

• 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.

  PMID: 35388806 BACKGROUND

• 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.

  PMID: 25829400 BACKGROUND

• 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.

  PMID: 35936732 BACKGROUND

• 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.

  PMID: 33808825 BACKGROUND

• 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.

  PMID: 34844845 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Salivary Gland Adenoma, Pleomorphic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nadia M Moustafa, PhD degree

  Assiut University

  STUDY DIRECTOR

• Aalaa W Hussein, master

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mohamed A Mekkawy, PhD degree

  Assiut University

  STUDY CHAIR

• Nahla M mahmoud, PhD degree

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Aalaa W Hussein, master

CONTACT

+201092855007; aalaawhy@gmail.com

Nadia M Moustafa, PhD degree

CONTACT

01125006468; drnadia1980@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: January 20, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

EG (1)