Prostate NeoplasmNCT05460312
Protein Kinase A in Prostate Cancer Tissue.
An observational study of Prostate Neoplasm and Inflammation, run by Ziv Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Neoplasm, Inflammation, Benign Hyperplasia of Prostate
- What is being tested?
- prostate biopsy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 100 consecutive men referred to prostate biopsy due to clinical suspicion of prosatet cancer.
Who may be able to join
- Men
- Clinical suspicion of prostate cancer
- Referred for biopsy
- Able to sign informed consent.
Who cannot join
- Previous prostate irradiation
- Chronic prostatitis
- Previous prostate surgery
- Recent urinary tract infection (3 months prior to biopsy).
- Indwelling urinary catheter
About this study
Official title: Assessment of the Expression and Activity of Protein Kinase A in Prostate Cancer Tissue
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.
Read the 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.
- Being tested
- prostate biopsy
- Keywords
- protein kinase A, immunohistochemistry, prostate cancer, prostate biopsy
- Medical subject headings
- Prostatic Neoplasms, Inflammation, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate biopsyDiagnostic test
trans rectal ultrasound guided biopsies of prostate . Biopsy smaples will be referred to staining and western blot analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of PKA in prostate cancer versus benign tissue
Immunohistochemical staining of paraffin sections of prostatebiopsies for PKA, western blot analysisi of tissue.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Mar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ran Katz, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460312
- Sponsor's protocol ID
- PKA-prostate
- Status last verified
- Jan 2023
- First submitted
- 12 Jul 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Expression and Activity of Protein Kinase A in Prostate Cancer Tissue
- ClinicalTrials.gov ID
- NCT05460312
- Acronym / sponsor ID
- PKA-prostate
- Keywords
- protein kinase A, immunohistochemistry, prostate cancer, prostate biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 100 consecutive men referred to prostate biopsy due to clinical suspicion of prosatet cancer.
Key inclusion criteria (4 listed)
- Men
- Clinical suspicion of prostate cancer
- Referred for biopsy
- Able to sign informed consent.
Key exclusion criteria (5 listed)
- Previous prostate irradiation
- Chronic prostatitis
- Previous prostate surgery
- Recent urinary tract infection (3 months prior to biopsy).
- Indwelling urinary catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prostate biopsytrans rectal ultrasound guided biopsies of prostate . Biopsy smaples will be referred to staining and western blot analysis. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Neoplasm and Inflammation, run by Ziv Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of PKA in prostate cancer versus benign tissue (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.