Clinical trial NCT04825691: ERG Protein Expression in Prostatic Adenocarcinoma and Its Clinicopathological Features
Official title: ERG Protein Expression in Prostatic Acinar Adenocarcinoma and Its Correlation With Clinicopathological Features
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Adenocarcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All cases diagnosed as prostatic acinar adenocarcinoma.

Brief summary: Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Detailed description: Prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. The burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. Although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (IHC) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. Out of these markers, Ets-related gene (ERG product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors ERG-transmembrane protease, serine 2 fusion. ERG is a transcription factor belonging to the erythroblast transformation-specific (ETS) family. It is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. This proto-oncogene is expressed in the urogenital tract and hematopoietic cells. Gene fusions involving sequences of transmembrane protease serine 2 (promoter of TMPRSS2) and protein coding sequences of ERG result in over expression of ERG in prostatic tumors. This TMPRSS2-ERG fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. Genetic rearrangements were not identified in epithelial carcinomas until Tomlins et al. demonstrated ERG gene fusions in prostatic carcinoma.The presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma.

TMPRSS2-ERG fusion results in constitutive expression of ERG oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. Moreover, TMPRSS2-ERG fusion gene product can be an important therapeutic target in prostatic cancer. Immunohistochemical (IHC) expression of ERG oncoprotein may serve as a surrogate biomarker of TMPRSS2-ERG fusion gene. Therefore in the present study we aimed to evaluate the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.

Eligibility criteria: Inclusion Criteria:

* All cases diagnosed as prostatic acinar adenocarcinoma

Exclusion Criteria:

* Other types of prostatic cancer.

Primary outcomes:
measure: Evaluation the ERG expression in prostatic acinar adenocarcinoma
timeFrame: 3 days
Secondary outcomes:
measure: Correlation between ERG expression with clinicopathological features.
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
citation: Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
citation: Clark JP, Cooper CS. ETS gene fusions in prostate cancer. Nat Rev Urol. 2009 Aug;6(8):429-39. doi: 10.1038/nrurol.2009.127.
citation: Kumar-Sinha C, Tomlins SA, Chinnaiyan AM. Recurrent gene fusions in prostate cancer. Nat Rev Cancer. 2008 Jul;8(7):497-511. doi: 10.1038/nrc2402. Epub 2008 Jun 19.
citation: Berg KD, Vainer B, Thomsen FB, Roder MA, Gerds TA, Toft BG, Brasso K, Iversen P. ERG protein expression in diagnostic specimens is associated with increased risk of progression during active surveillance for prostate cancer. Eur Urol. 2014 Nov;66(5):851-60. doi: 10.1016/j.eururo.2014.02.058. Epub 2014 Mar 7.