An observational study in Prostate Cancer, Prostate Cancer Metastatic and Prostate Cancer Recurrent, sponsored by Assiut University. Not yet recruiting. Open to male participants. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Assiut University · Observational
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?
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 59 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Patients with known prostate cancer referred for 18-F PSMA PET/CT study
Exclusion Criteria:
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
Time frame: 2 years
Correlation between quantitative measures and other clinical, pathological and laboratory measures
Correlation between quantitative measures and tumor burden of 18-F PSMA PET/CT with clinical, pathological and laboratory data including serum PSA, and Gleason Score
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assiut University