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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
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA PET/CT | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
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Inclusion Criteria:
Exclusion Criteria:
male patients with prostate cancer
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aalaa W Hussein, master | Contact | +201092855007 | aalaawhy@gmail.com | |
| Nadia M Moustafa, PhD degree | Contact | 01125006468 | drnadia1980@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nadia M Moustafa, PhD degree | Assiut University | Study Director |
| Aalaa W Hussein, master | Assiut University | Principal Investigator |
| Mohamed A Mekkawy, PhD degree |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Recruiting | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35155262 | Background | 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. | |
| 35388806 | Background | Liu 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Assiut University |
| Study Chair |
| Nahla M mahmoud, PhD degree | Assiut University | Study Director |
| 25829400 | Background | Xu 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. |
| 35936732 | Background | Liu 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. |
| 33808825 | Background | Awenat 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. |
| 34844845 | Result | Tang 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |