Prostatic NeoplasmsNCT06209853
Correlation Between PSA Levels and F-18 PSMA PET/CT Findings in Prostate Cancer Patient
An observational study of Prostatic Neoplasms, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- PSMA PET/CT
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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
Who may be able to join
- Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Prostate-Specific Antigen (PSA) Levels and Fluorine-18 Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography (F-18 PSMA PET/CT) Scan Findings in Patients With Prostate Cancer
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
Read the detailed description
Prostate cancer (PC) is a prevalent malignancy that occurs primarily in old males, it is the third most common with regards of mortality (1,2). prostate-specific membrane antigen (PSMA) known as glutamate carboxypeptidase II, is a transmembrane glycoprotein highly expressed in PC cells. PSMA expression tends to increase with increased pathological Gleason grade and is thought to be upregulated with the emergence of androgen independence (2).
PSMA PET/CT imaging is important for correct primary staging and for the detection of sites of biochemical recurrence.
prostate-specific antigen Liu et al., in 2022 stated that as serum PSA levels increase, the diagnostic accuracy of F-PSMA-1007 PET/CT also improves (3) Bergero et al., in 2022 evaluated the diagnostic correlation between PSA and positivity of F-18 PSMA PET/CT in patients with biochemically recurrent prostate cancer (RPC), reporting it as a very good predictor of positivity in 18F-PSMA PET/CT in patients with RPC (4).
A Meta-Analysis in 2022 found that the detection rate (DR) of the18F-PSMA-1007 PET/CT was also improved with increasing serum PSA levels (5) Another Meta-Analysis in 2019 studied the DR of F-18 PSMA PET/CT revealing that DR is related to PSA values with significant lower DR in patients with PSA<0.5 ng/mL (6)
- Conditions
- Prostatic Neoplasms
- Being tested
- PSMA PET/CT
- Keywords
- PSMA PET/CT, Prostate, PSA
- Medical subject headings
- Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CTDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline
Secondary outcomes (1)
To evaluate the impact of PET/CT findings on the patient management
determine dependency of PSA level in patient management in initial staging or biochemical recurrence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Jan 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aalaa Wael Hussein, Assiut University
- Investigators
- Nadia M Moustafa, PhD degree, Study director, Assiut UniversityAalaa W Hussein, master, Principal investigator, Assiut UniversityMohamed A Mekkawy, PhD degree, Study chair, Assiut UniversityNahla M mahmoud, PhD degree, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209853
- Sponsor's protocol ID
- F-18 PSMA in prostate cancer
- Status last verified
- Jul 2024
- First submitted
- 6 Jan 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35155262Liu 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.
PubMed 35388806Xu 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.
PubMed 25829400Liu 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.
PubMed 35936732Awenat 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.
PubMed 33808825Tang 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.
PubMed 34844845
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Prostate-Specific Antigen (PSA) Levels and Fluorine-18 Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography (F-18 PSMA PET/CT) Scan Findings in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06209853
- Acronym / sponsor ID
- F-18 PSMA in prostate cancer
- Conditions
- Prostatic Neoplasms
- Keywords
- PSMA PET/CT, Prostate, PSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
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
Detailed description
Prostate cancer (PC) is a prevalent malignancy that occurs primarily in old males, it is the third most common with regards of mortality (1,2). prostate-specific membrane antigen (PSMA) known as glutamate carboxypeptidase II, is a transmembrane glycoprotein highly expressed in PC cells. PSMA expression tends to increase with increased pathological Gleason grade and is thought to be upregulated with the emergence of androgen independence (2).
PSMA PET/CT imaging is important for correct primary staging and for the detection of sites of biochemical recurrence.
prostate-specific antigen Liu et al., in 2022 stated that as serum PSA levels increase, the diagnostic accuracy of F-PSMA-1007 PET/CT also improves (3) Bergero et al., in 2022 evaluated the diagnostic correlation between PSA and positivity of F-18 PSMA PET/CT in patients with biochemically recurrent prostate cancer (RPC), reporting it as a very good predictor of positivity in 18F-PSMA PET/CT in patients with RPC (4).
A Meta-Analysis in 2022 found that the detection rate (DR) of the18F-PSMA-1007 PET/CT was also improved with increasing serum PSA levels (5) Another Meta-Analysis in 2019 studied the DR of F-18 PSMA PET/CT revealing that DR is related to PSA values with significant lower DR in patients with PSA<0.5 ng/mL (6)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET/CTPatients 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 | Device | – |
Primary outcome
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings
Time frame: baseline
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)
1 secondary outcome
To evaluate the impact of PET/CT findings on the patient management
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 35155262Tsechelidis I, Vrachimis A. PSMA PET in Imaging Prostate Cancer. Front Oncol. 2022 Jan 28;12:831429. doi: 10.3389/fonc.2022.831429. eCollection 2022.
- Background: PubMed 35388806Liu 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.
- Background: PubMed 25829400Xu 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.
- Background: PubMed 35936732Liu 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.
- Background: PubMed 33808825Awenat 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.
- Results publication: PubMed 34844845Tang 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.
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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. This study is not recruiting at the moment.
Nadia M Moustafa, PhD degree study director
Assiut University
Aalaa W Hussein, master principal investigator
Assiut University
Mohamed A Mekkawy, PhD degree study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Assiut University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aalaa W Hussein, master (+201092855007, aalaawhy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To correlate between PSA Levels and F-18 PSMA PET/CT Scan findings (time frame: baseline). 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 NCT06209853, which also lists 6 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 15 Jul 2024.