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

18F-PSMA PET/CT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07485881
Enrollment
59
Registered
2026-03-20
Start date
2026-05-01
Completion date
2028-06-01
Last updated
2026-03-20

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

Conditions

Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent

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?

Detailed description

Prostate cancer represents the most frequently diagnosed malignancy in men worldwide and accounts for approximately 30% of all new male cancer diagnoses in 2025, with recent data highlighting a significant 3% annual increase in incidence rates, particularly in advanced-stage disease\[1\]. The accurate staging and restaging of prostate cancer (PCa) are critical for determining the optimal therapeutic approach, particularly in detecting nodal or distant metastases \[2\]. The Gleason score and Prostate-Specific Antigen (PSA) levels serve as the foundational pillars for the clinical staging and initial risk stratification of prostate cancer. The Gleason score, which evaluates the histological architecture and cellular differentiation of prostate tissue from a biopsy, is calculated by summing the two most prevalent cancer patterns (yielding scores typically ranging from 6 to 10) \[3\]. Concurrently, the serum PSA level acts as a biochemical marker reflecting the overall volume and activity of the prostatic disease \[3,4\]. Computed Tomography (CT) has been the standard imaging modality for assessment of metastatic sites; however, it relies primarily on anatomy, such as lymph node size and shape, which often leads to low sensitivity in detecting early-stage or micrometastatic disease\[5\]. Recently, in response to these limitations the landscape has shifted toward molecular imaging with PSMA-targeted imaging using PET/CT which targets the Prostate-Specific Membrane Antigen (PSMA) -a protein significantly overexpressed in malignant prostate cells-allowing for the detection of lesions independent of their anatomical size \[6\]. Evidence suggests that PSMA PET/CT provides superior diagnostic accuracy, higher sensitivity, and better specificity compared to CT alone, often leading to a change in clinical management for a substantial percentage of patients\[2,7\]. Additionally, the clinical utility of 18-F PSMA PET/CT is significantly enhanced by its capacity for calculating quantitative analysis. Metrics such as the maximum Standardized Uptake Value (SUVmax), PSMA-derived tumor volume (PSMA-TV), and total lesion PSMA (TL-PSMA) provide an objective, reproducible assessment of disease burden \[8\]. In this study, we aim to compare the diagnostic performance of 18-F PSMA PET/CT and CT alone in staging, assessment of therapy response, as well as evaluation of biochemical recurrence

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients with claustrophobia * Patients refuse to do the scan

Design outcomes

Primary

MeasureTime frameDescription
Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients2 yearsComparison of diagnostic performance of 18-F PSMA PET/CT and CT in staging, assessment of therapy response and evaluation of biochemical recurrence

Secondary

MeasureTime frameDescription
Correlation between quantitative measures and other clinical, pathological and laboratory measures2 yearsCorrelation between quantitative measures and tumor burden of 18-F PSMA PET/CT with clinical, pathological and laboratory data including serum PSA, and Gleason Score

Contacts

CONTACTMaram Shafeek, MSc
maram.mostafa996@gmail.com+201019050584

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026