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Enrolling by invitationNCT06505356Updated Mar 13, 2025

Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage

An interventional study of Prostate biopsy in Prostate Cancer and Prostate Inflammation, sponsored by Edgaras Burzinskis. Enrolling by invitation at 1 site in Lithuania. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Edgaras Burzinskis · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
Male
01

Study summary

  1. Identify the local inflammatory response in prostate tissue and the systemic response in the blood of patients with prostate cancer, depending on the stage of the disease, and evaluate their prognostic value.
  2. Identify the spectrum of microorganisms and antibiotic resistance in patients with prostate cancer prior to prostate biopsy, and assess the risk of complications when using Ciprofloxacin and Fosfomycin.
  3. Determine the significance of GAS5, JAZF1, and CTBP2 gene polymorphisms in the development of prostate cancer.
  4. Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer.
Read the detailed description

Goal 1: Identify Local Inflammatory Response in Prostate Tissue and Systemic Response in the Blood of Patients with Prostate Cancer Depending on the Stage of the Disease and Evaluate Their Prognostic Value

Objective: To investigate and characterize both local and systemic inflammatory responses in prostate cancer patients at various disease stages.

Approach:

  • Local Inflammatory Response: Examine prostate tissue samples to identify markers and levels of inflammation. This involves histological analysis and possibly molecular assays (e.g., PCR, immunohistochemistry).
  • Systemic Inflammatory Response: Measure inflammatory markers in the blood, such as C-reactive protein (CRP), interleukins (e.g., IL-6), and other cytokines.
  • Disease Staging: Correlate these inflammatory responses with the stage of prostate cancer (e.g., localized, advanced, metastatic) to understand the progression of the disease.
  • Prognostic Value: Analyze the data to determine if these inflammatory markers can predict disease progression, response to treatment, and overall prognosis.

Expected Outcome: Establish a comprehensive profile of inflammatory responses associated with different stages of prostate cancer and identify potential prognostic biomarkers.

Goal 2: Identify the Spectrum of Microorganisms and Antibiotic Resistance in Patients with Prostate Cancer Prior to Prostate Biopsy and Assess the Risk of Complications When Using Ciprofloxacin and Fosfomycin

Objective: To profile the microbial flora and antibiotic resistance in prostate cancer patients before biopsy, and evaluate the safety and efficacy of Ciprofloxacin and Fosfomycin.

Approach:

  • Microbial Spectrum: Collect and analyze urine, prostatic fluid, and other relevant samples to identify bacterial species present using culture methods and molecular techniques.
  • Antibiotic Resistance: Test the identified microorganisms for resistance to common antibiotics, focusing on Ciprofloxacin and Fosfomycin.
  • Risk Assessment: Review patient outcomes post-biopsy to assess the incidence of complications such as infection and adverse reactions, particularly in relation to the use of the studied antibiotics.
  • Data Analysis: Correlate microbial profiles and resistance patterns with clinical outcomes to determine the risk factors for complications.

Expected Outcome: Develop guidelines for antibiotic use in prostate biopsy procedures based on microbial and resistance profiles to minimize the risk of complications.

Goal 3: Determine the Significance of GAS5, JAZF1, and CTBP2 Gene Polymorphism in the Development of Prostate Cancer

Objective: To investigate the role of specific gene polymorphisms (GAS5, JAZF1, and CTBP2) in the susceptibility to and development of prostate cancer.

Approach:

  • Genetic Analysis: Collect DNA samples from prostate cancer patients and a control group. Perform genotyping to identify polymorphisms in the GAS5, JAZF1, and CTBP2 genes.
  • Association Studies: Conduct statistical analyses to compare the frequency of these polymorphisms in patients versus controls. Assess their correlation with the presence and severity of prostate cancer.
  • Functional Studies: Where possible, explore the biological impact of these polymorphisms on gene expression and function, potentially through in vitro or in vivo models.

Expected Outcome: Identify genetic markers that contribute to prostate cancer risk, enhancing understanding of disease mechanisms and potential targets for intervention.

Goal 4: Evaluate the Associations of One Gene Polymorphism with the Clinical Course of Disease in Patients with Prostate Cancer

Objective: To determine how a specific gene polymorphism influences the clinical trajectory of prostate cancer.

Approach:

  • Polymorphism Selection: Choose a gene polymorphism of interest, potentially based on findings from previous research or Goals 1-3.
  • Clinical Data Collection: Gather comprehensive clinical data from prostate cancer patients, including disease stage, progression, treatment response, and outcomes.
  • Genotype-Phenotype Correlation: Perform genetic testing to identify the presence of the polymorphism in these patients. Correlate the genetic data with clinical parameters to assess associations.
  • Statistical Analysis: Use appropriate statistical methods to determine the significance of the associations between the polymorphism and various clinical aspects of prostate cancer.

Expected Outcome: Gain insights into how genetic variations can affect the progression and treatment response in prostate cancer, potentially guiding personalized treatment approaches.

Prostate Cancer and Biopsy Related Acronyms:

  1. TRUS: Transrectal Ultrasound

    • A medical imaging technique used to visualize the prostate gland and guide the biopsy needle.
  2. PSA: Prostate-Specific Antigen

    • A protein produced by the prostate gland, elevated levels of which can indicate prostate cancer.
  3. Gleason Score:

    • A grading system used to determine the aggressiveness of prostate cancer based on the microscopic appearance of prostate tissue.

Genetic and Molecular Biology Acronyms:

  1. GAS5: Growth Arrest Specific 5

    • A long non-coding RNA involved in regulating cell growth and apoptosis, often studied in cancer research.
  2. JAZF1: JAZF Zinc Finger 1

    • A gene associated with various cellular processes, including transcriptional regulation and potentially linked to cancer.
  3. CTBP2: C-terminal Binding Protein 2

    • A protein that functions as a transcriptional co-repressor, playing a role in gene expression regulation and cancer.
  4. PCR: Polymerase Chain Reaction

    • A laboratory technique used to amplify DNA sequences, making it easier to study genetic material in detail.
  5. NGS: Next-Generation Sequencing

    • Advanced sequencing technologies that allow for rapid and detailed sequencing of large amounts of DNA.

Inflammatory Markers:

  1. 6Ckine (CCL21): Chemokine (C-C motif) ligand 21

    • A cytokine involved in the immune response and potentially linked to inflammation in cancer.
  2. Eotaxin (CCL11): Chemokine (C-C motif) ligand 11

    • A chemokine that attracts eosinophils and is associated with allergic responses and inflammation.
  3. Fractalkine (CX3CL1): Chemokine (C-X3-C motif) ligand 1

    • A chemokine involved in immune cell migration and adhesion, playing a role in inflammation and cancer.
  4. IFN gamma: Interferon gamma

    • A cytokine critical for innate and adaptive immunity against viral and intracellular bacterial infections and for tumor control.
  5. IL-2: Interleukin 2

    • A cytokine that promotes the growth and differentiation of T cells, important in the immune response.
  6. IL-6: Interleukin 6

    • A cytokine involved in inflammation and infection responses, also linked to cancer progression.
  7. IL-8 (CXCL8): Interleukin 8

    • A chemokine that attracts neutrophils and is involved in the inflammatory response.
  8. IL-10: Interleukin 10

    • A cytokine with anti-inflammatory properties, regulating immune responses.
  9. IL-18: Interleukin 18

    • A cytokine that induces interferon gamma production, playing a role in inflammation and immune responses.
  10. MIP-3 beta (CCL19): Macrophage Inflammatory Protein 3 beta

    • A chemokine involved in immune cell trafficking and inflammatory responses.
  11. PDGF-BB: Platelet-Derived Growth Factor BB

    • A growth factor involved in blood vessel formation and the growth of various cell types.
  12. TNF alpha: Tumor Necrosis Factor alpha

    • A cytokine involved in systemic inflammation and is part of the immune system's response to cancer.
02

Conditions studied

  • Prostate Cancer
  • Prostate Inflammation
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 400 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Edgaras Burzinskis as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: Male patients aged 18 years and older.
  2. Diagnosis: Patients who are suspected of having prostate cancer based on clinical data and standard diagnostic protocols.
  3. Disease Stage: Patients at any stage of suspected prostate cancer (localized, locally advanced, or ).
  4. Consent: Ability and willingness to provide written .
  5. Clinical Data Availability: Availability of comprehensive clinical data.
  6. Sample Provision: Willingness to provide blood and/or tissue samples for genetic and inflammatory marker analysis.

Exclusion criteria

Exclusion Criteria:

  1. Prior Treatment: Patients who have undergone any prior prostate cancer treatments such as surgery, radiation therapy, or systemic therapies (e.g., hormone therapy, chemotherapy).
  2. Other : Presence of other concurrent malignancies, except for adequately treated basal cell or squamous cell skin cancer.
  3. Severe Comorbidities: Patients with severe or uncontrolled comorbid conditions that could interfere with study participation or data interpretation (e.g., severe cardiovascular, pulmonary, hepatic, or renal diseases).
  4. Infection: Active infections or other severe medical conditions that could compromise patient safety or study integrity.
  5. Non-compliance: Inability to comply with study procedures, follow-up requirements, or any condition that, in the investigator's opinion, could interfere with study participation.
  6. Medication Use: Use of medications that could interfere with the study results, such as drugs.

Additional Considerations:

  • Screening: All potential participants will undergo a screening process to verify eligibility criteria.
  • Confidentiality: Ensure all patient data is handled in accordance with privacy regulations and ethical guidelines.
  • Follow-Up: Participants should be willing to attend regular follow-up visits for ongoing data collection and monitoring of disease progression and treatment response.

By setting these criteria, the study aims to create a well-defined patient cohort for evaluating the relationship between genetic and inflammatory markers and prostate cancer aggressiveness.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Patients with diagnosed prostate cancer after TRUS prostate biopsy

    Prostate Biopsy Procedure (TRUS-guided): Preparation: Explain procedure, obtain consent. Administer antibiotics, discontinue blood thinners. No bowel prep needed. Procedure: Position: Patient lies on side or in lithotomy position. Anesthesia: Apply local anesthetic. Insert ultrasound probe into rectum to visualize prostate. Guide needle into prostate using ultrasound. Take 10-12 tissue samples. Post-procedure: Monitor for complications. Continue antibiotics, drink fluids, avoid strenuous activity. Side Effects: Minor blood in urine, semen, or rectum, resolving in days to weeks. Follow-up: Discuss results within a week. Expected result: confirmation of prostate cancer.

    Procedure: Prostate biopsy

  • Experimental
    Patients without a prostate cancer diagnosis after TRUS prostate biopsy

    Experimental: Patients without a prostate cancer diagnosis after TRUS biopsy. Prostate Biopsy (TRUS-guided). Preparation: Explain procedure, benefits, and risks; obtain consent. Administer antibiotics; discontinue blood thinners. No bowel prep. Procedure: Patient lies on their side or in lithotomy position. Apply local anesthetic. Insert lubricated ultrasound probe into rectum. Guide thin needle into prostate using ultrasound. Take 10-12 tissue samples. Post-procedure: Monitor for complications. Continue antibiotics, drink fluids, avoid strenuous activity, monitor for complications. Minor blood in urine, semen, or rectum may occur, resolving in days to weeks. Follow-up: Discuss biopsy results within a week. Expected result: Absence of prostate cancer.

    Procedure: Prostate biopsy

Interventions

  • ProcedureProstate biopsy

    Transrectal prostate biopsy

06

What researchers measure

Primary outcomes

  1. Inflammatory markers' effect on prostate cancer aggressiveness

    Aim: Assess if selected inflammatory markers are linked to prostate cancer aggressiveness by measuring their concentrations and analyzing correlations with disease severity. Markers: 6Ckine (CCL21) Eotaxin (CCL11) Fractalkine (CX3CL1) IFN gamma IL-2 IL-6 IL-8 (CXCL8) IL-10 IL-18 MIP-3 beta (CCL19) PDGF-BB TNF alpha Objectives: 1. Measure marker levels in blood samples. 2. Investigate links between marker levels and cancer aggressiveness. 3. Use Gleason score, seminal vesicles invasion, and lymph nodes invasion. Outcomes: Identify markers linked to aggressiveness. Develop prognostic tools or therapies. Categorize patients by risk. This study aims to understand inflammation's role in prostate cancer and identify biomarkers for predicting aggressiveness.

    Time frame: 2 weeks

  2. Genetic polymorphism markers' effect on prostate cancer aggressiveness

    Genetic Polymorphism Markers' Effect on Prostate Cancer Aggressiveness Objectives: 1. Examine GAS5, JAZF1, CTBP2 polymorphisms and their variations in patients. 2. Measure polymorphism levels and their relationship with cancer aggressiveness. 3. Correlate polymorphisms with Gleason score, seminal vesicles invasion, and lymph nodes invasion. Expected Outcomes: * Identify markers linked to aggressiveness. * Provide insights for genetic tests. * Understand molecular mechanisms and develop therapies. This study clarifies the role of genetic polymorphisms in prostate cancer aggressiveness, aiding prognosis and treatment.

    Time frame: 2 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Aug 2028, 47 months after the start.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 47 months is close to that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2024
First posted
Jul 17, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Aug 30, 2028
CompletionEst.
Aug 30, 2028
Last update
Mar 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06505356
Lead sponsor
Edgaras Burzinskis
Responsible party
Edgaras Burzinskis (Principal Investigator, Lithuanian University of Health Sciences) — Sponsor-investigator
First posted
Jul 17, 2024
Start date
Sep 1, 2024
Primary completion
Aug 30, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Mar 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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