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Clinical Trials/NCT05460312
NCT05460312
Not yet recruiting
Not Applicable

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

Ziv Hospital0 sites100 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Neoplasm
Sponsor
Ziv Hospital
Enrollment
100
Primary Endpoint
The distribution of PKA in prostate cancer versus benign tissue
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
May 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Ziv Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ran Katz

Dr. Ran Katz, Head, department of Urology, ziv medical center

Ziv Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

The distribution of PKA in prostate cancer versus benign tissue

Time Frame: 1 year

Immunohistochemical staining of paraffin sections of prostatebiopsies for PKA, western blot analysisi of tissue.

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