NCT05460312

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

July 12, 2022

Last Update Submit

January 24, 2023

Conditions

Keywords

protein kinase Aimmunohistochemistryprostate cancerprostate biopsy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

prostate biopsyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen referred to prostate biopsies.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohort of 100 consecutive men referred to prostate biopsy due to clinical suspicion of prosatet cancer.

You may qualify if:

  • Men
  • Clinical suspicion of prostate cancer
  • Referred for biopsy
  • Able to sign informed consent.

You may not qualify if:

  • Previous prostate irradiation
  • Chronic prostatitis
  • Previous prostate surgery
  • Recent urinary tract infection (3 months prior to biopsy).
  • Indwelling urinary catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsInflammationProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ran Katz, Head, department of Urology, ziv medical center

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

January 26, 2023

Record last verified: 2023-01