Protein Kinase A in Prostate Cancer Tissue.

Sponsor

Ziv Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05460312

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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. apossible mechanism is induction of an inflamation resulting in cellular atypia and pre-malignant changes in the affected tissue by inducing a pro-inflamatory response or changes in extra cellular matrix. Protein Kinase A (PKA) is a key stone enzyme in various intra-cellular processes. Various infections' inflamations 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 intracelullar distribution.

Condition or Disease	Intervention/Treatment	Phase
Prostate Neoplasm Inflammation Benign Hyperplasia of Prostate	Diagnostic Test: prostate biopsy

Detailed Description

The study will be condcted 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 acoording to MRI findings (Fusion biopsies) if relevant. One additional biopsy will be taken from each lobe of th eprostate and immediatly freezed in -80 celsius degrees. Routine biopsies will be fixed in formaldehide and embaded in parrafin and will undergo routine patholgical analysis and staining.

Following pathological analysis, paraffin slides will be undergo immunohistochemical staining for PKA, comparing cancerous tissue to normal serrounding tissue. the fresh frozen tissue will undergo western blot analysis for quantitative expression of PKA and its sub units.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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