Prostate CancerNCT07485881
18F-PSMA PET/CT Versus CT Alone in Assessment of Prostatic Cancer Patients
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients with known prostate cancer referred for 18-F PSMA PET/CT study
Who cannot join
- Patients with claustrophobia
- Patients refuse to do the scan
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 18F-PSMA PET/CT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients
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?
Read the 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
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Mostafa Shafeek, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485881
- Sponsor's protocol ID
- 18F PSMA PET/CT
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40892160Mazzone 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.
PubMed 40155242Hadaschik 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.
PubMed 32370910Morawitz 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.
PubMed 33485127
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-PSMA PET/CT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients
- ClinicalTrials.gov ID
- NCT07485881
- Acronym / sponsor ID
- 18F PSMA PET/CT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with known prostate cancer referred for 18-F PSMA PET/CT study
Key exclusion criteria (2 listed)
- Patients with claustrophobia
- Patients refuse to do the scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients
Time frame: 2 years
Comparison of diagnostic performance of 18-F PSMA PET/CT and CT in staging, assessment of therapy response and evaluation of biochemical recurrence
1 secondary outcome
Correlation between quantitative measures and other clinical, pathological and laboratory measures
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Background: PubMed 40892160Kratzer 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.
- Background: PubMed 40155242Mazzone 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.
- Background: PubMed 32370910Hadaschik 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.
- Background: PubMed 33485127Morawitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Cancer Metastatic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maram Shafeek, MSc (+201019050584, maram.mostafa996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing 18-F PSMA PET/CT and CT in evaluation of prostatic cancer patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07485881, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.