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NCT05460312 Clinical Trial

Protein Kinase A in Prostate Cancer Tissue.

Inflammation Clinical Trial

Official title:
Assessment of the Expression and Activity of Protein Kinase A in Prostate Cancer Tissue

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05460312
Other study ID # PKA-prostate
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date May 2024

Study information
Verified date January 2023
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prostate cancer is the most common malignancy in men. documented risk factors of prostate cancer are age, ethnicity, various genomic mutations and family history of prostate cancer. The cellular mechanisms of malignant transformation are numerous and not completely understood. A possible mechanism is induction of an inflammation resulting in cellular atypia and pre-malignant changes in the affected tissue by inducing a pro-inflammatory response or changes in extra cellular matrix. Protein Kinase A (PKA) is a key stone enzyme in various intra-cellular processes. Various infections' inflammations and malignancies were proved to impact PKA activity. The research hypothesis is that prostate cancer tissue will show a unique profile of PKA activity, regulation and intracellular distribution.

Description:

The study will be conducted among men referred to prostate biopsy due to clinical suspicion of malignancy. 100 consecutive patients will undergo prostate biopsies. Biopsies will be taken from both lobes of the prostate (standard protocol) and additional biopsies will be taken according to MRI findings (Fusion biopsies) if relevant. One additional biopsy will be taken from each lobe of the prostate and immediately freezed in -80 Celsius degrees. Routine biopsies will be fixed in formaldehyde and embedded in paraffin and will undergo routine pathological analysis and staining. Following pathological analysis, paraffin slides will be undergo immunohistochemically staining for PKA, comparing cancerous tissue to normal surrounding tissue. the fresh frozen tissue will undergo western blot analysis for quantitative expression of PKA and its sub units.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria: - Men - Clinical suspicion of prostate cancer - Referred for biopsy - Able to sign informed consent. Exclusion Criteria: - Previous prostate irradiation - Chronic prostatitis - Previous prostate surgery - Recent urinary tract infection (3 months prior to biopsy). - Indwelling urinary catheter

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• prostate biopsy
trans rectal ultrasound guided biopsies of prostate . Biopsy smaples will be referred to staining and western blot analysis.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The distribution of PKA in prostate cancer versus benign tissue Immunohistochemical staining of paraffin sections of prostatebiopsies for PKA, western blot analysisi of tissue. 1 year
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