Protein Kinase A in Prostate Cancer Tissue.

Not yet recruiting

• Conditions: Inflammation; Prostate Neoplasm; Benign Hyperplasia of Prostate

• Registration Number: NCT05460312
• Lead Sponsor: Ziv Hospital

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.

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Study Start: 2023-03-01
• Primary Completion: 2024-03
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distribution of PKA in prostate cancer versus benign tissue	1 year	Immunohistochemical staining of paraffin sections of prostatebiopsies for PKA, western blot analysisi of tissue.