Protein Kinase A in Prostate Cancer Tissue.

NCT ID: NCT05460312

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-05-31

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.

Conditions

Prostate Neoplasm; Inflammation; Benign Hyperplasia of Prostate

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

prostate biopsy

trans rectal ultrasound guided biopsies of prostate . Biopsy smaples will be referred to staining and western blot analysis.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ran Katz

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PKA-prostate

Identifier Type: -

Identifier Source: org_study_id