18F-PSMA PET/CT Versus CT Alone in Assessment of Prostatic Cancer Patients

NCT07485881 | Not Yet Recruiting DMC

• 1 other identifier: 18F PSMA PET/CT
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the diagnostic performance of 18-F PSMA PET/CT and CT alone in initial staging, assessment of therapy response, as well as evaluation of biochemical recurrence of prostatic cancer patients The main question it aims to answer is: Does 18-F PSMA PET/CT have a superior role over CT in evaluation of prostatic cancer patients?

Conditions

Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients

  Comparison of diagnostic performance of 18-F PSMA PET/CT and CT in staging, assessment of therapy response and evaluation of biochemical recurrence

  2 years

Secondary Outcomes (1)

• Correlation between quantitative measures and other clinical, pathological and laboratory measures

  2 years

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known prostate cancer referred for doing 18F-PSMA PET/CT as a part of their initial evaluation, assessing of therapy response, or detection of suspected biochemical recurrence

You may qualify if:

• Patients with known prostate cancer referred for 18-F PSMA PET/CT study

You may not qualify if:

• Patients with claustrophobia
• Patients refuse to do the scan

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Kratzer TB, Mazzitelli N, Star J, Dahut WL, Jemal A, Siegel RL. Prostate cancer statistics, 2025. CA Cancer J Clin. 2025 Nov-Dec;75(6):485-497. doi: 10.3322/caac.70028. Epub 2025 Sep 2.

  PMID: 40892160 BACKGROUND

• Mazzone E, Cannoletta D, Quarta L, Chen DC, Thomson A, Barletta F, Stabile A, Moon D, Eapen R, Lawrentschuk N, Montorsi F, Siva S, Hofman MS, Chiti A, Murphy DG, Briganti A, Perera ML. A Comprehensive Systematic Review and Meta-analysis of the Role of Prostate-specific Membrane Antigen Positron Emission Tomography for Prostate Cancer Diagnosis and Primary Staging before Definitive Treatment. Eur Urol. 2025 Jun;87(6):654-671. doi: 10.1016/j.eururo.2025.03.003. Epub 2025 Mar 27.

  PMID: 40155242 BACKGROUND

• Hadaschik B, Herrmann K. Re: Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study. Eur Urol. 2020 Sep;78(3):470-471. doi: 10.1016/j.eururo.2020.04.051. Epub 2020 May 1. No abstract available.

  PMID: 32370910 BACKGROUND

• Morawitz J, Kirchner J, Lakes J, Bruckmann NM, Mamlins E, Hiester A, Aissa J, Loberg C, Schimmoller L, Arsov C, Antke C, Albers P, Antoch G, Sawicki LM. PSMA PET/CT vs. CT alone in newly diagnosed biochemical recurrence of prostate cancer after radical prostatectomy: Comparison of detection rates and therapeutic implications. Eur J Radiol. 2021 Mar;136:109556. doi: 10.1016/j.ejrad.2021.109556. Epub 2021 Jan 16.

  PMID: 33485127 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Maram Shafeek, MSc

CONTACT

+201019050584; maram.mostafa996@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maram Mostafa

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03