Correlation Between PSA Levels and F-18 PSMA PET/CT Findings in Prostate Cancer Patient

NCT ID: NCT06209853

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-20

Study Completion Date

2025-04-01

Brief Summary

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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

Detailed Description

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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

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Prostatic Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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PSMA PET/CT

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male Patients with pathologically proven prostate cancer who will be referred to nuclear medicine unit to perform F18 PSMA for different indications

Exclusion Criteria

* 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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aalaa Wael Hussein

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nadia M Moustafa, PhD degree

Role: STUDY_DIRECTOR

Assiut University

Aalaa W Hussein, master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mohamed A Mekkawy, PhD degree

Role: STUDY_CHAIR

Assiut University

Nahla M mahmoud, PhD degree

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Aalaa W Hussein, master

Role: CONTACT

+201092855007

Nadia M Moustafa, PhD degree

Role: CONTACT

01125006468

References

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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.

Reference Type BACKGROUND
PMID: 35155262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35388806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25829400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35936732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33808825 (View on PubMed)

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.

Reference Type RESULT
PMID: 34844845 (View on PubMed)

Other Identifiers

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F-18 PSMA in prostate cancer

Identifier Type: -

Identifier Source: org_study_id

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