Prostate CancerNCT06505356
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
A study testing Prostate biopsy in people with Prostate Cancer and Prostate Inflammation, run by Edgaras Burzinskis at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Inflammation
- What is being tested?
- Prostate biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2024to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Male patients aged 18 years and older.
- Diagnosis: Patients who are suspected of having prostate cancer based on clinical data and standard diagnostic protocols.
- Disease Stage: Patients at any stage of suspected prostate cancer (localized, locally advanced, or metastatic).
- Consent: Ability and willingness to provide written informed consent.
- Clinical Data Availability: Availability of comprehensive clinical data.
- Sample Provision: Willingness to provide blood and/or tissue samples for genetic and inflammatory marker analysis.
Who cannot join
- Prior Treatment: Patients who have undergone any prior prostate cancer treatments such as surgery, radiation therapy, or systemic therapies (e.g., hormone therapy, chemotherapy).
- Other Malignancies: Presence of other concurrent malignancies, except for adequately treated basal cell or squamous cell skin cancer.
- 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).
- Infection: Active infections or other severe medical conditions that could compromise patient safety or study integrity.
- 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.
- Medication Use: Use of medications that could interfere with the study results, such as immunosuppressive drugs.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
- 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.
- 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.
- Determine the significance of GAS5, JAZF1, and CTBP2 gene polymorphisms in the development of prostate cancer.
- 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:
- TRUS: Transrectal Ultrasound
- A medical imaging technique used to visualize the prostate gland and guide the biopsy needle.
- PSA: Prostate-Specific Antigen
- A protein produced by the prostate gland, elevated levels of which can indicate prostate cancer.
- 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:
- GAS5: Growth Arrest Specific 5
- A long non-coding RNA involved in regulating cell growth and apoptosis, often studied in cancer research.
- JAZF1: JAZF Zinc Finger 1
- A gene associated with various cellular processes, including transcriptional regulation and potentially linked to cancer.
- CTBP2: C-terminal Binding Protein 2
- A protein that functions as a transcriptional co-repressor, playing a role in gene expression regulation and cancer.
- PCR: Polymerase Chain Reaction
- A laboratory technique used to amplify DNA sequences, making it easier to study genetic material in detail.
- NGS: Next-Generation Sequencing
- Advanced sequencing technologies that allow for rapid and detailed sequencing of large amounts of DNA.
Inflammatory Markers:
- 6Ckine (CCL21): Chemokine (C-C motif) ligand 21
- A cytokine involved in the immune response and potentially linked to inflammation in cancer.
- Eotaxin (CCL11): Chemokine (C-C motif) ligand 11
- A chemokine that attracts eosinophils and is associated with allergic responses and inflammation.
- 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.
- IFN gamma: Interferon gamma
- A cytokine critical for innate and adaptive immunity against viral and intracellular bacterial infections and for tumor control.
- IL-2: Interleukin 2
- A cytokine that promotes the growth and differentiation of T cells, important in the immune response.
- IL-6: Interleukin 6
- A cytokine involved in inflammation and infection responses, also linked to cancer progression.
- IL-8 (CXCL8): Interleukin 8
- A chemokine that attracts neutrophils and is involved in the inflammatory response.
- IL-10: Interleukin 10
- A cytokine with anti-inflammatory properties, regulating immune responses.
- IL-18: Interleukin 18
- A cytokine that induces interferon gamma production, playing a role in inflammation and immune responses.
- MIP-3 beta (CCL19): Macrophage Inflammatory Protein 3 beta
- A chemokine involved in immune cell trafficking and inflammatory responses.
- PDGF-BB: Platelet-Derived Growth Factor BB
- A growth factor involved in blood vessel formation and the growth of various cell types.
- TNF alpha: Tumor Necrosis Factor alpha
- A cytokine involved in systemic inflammation and is part of the immune system's response to cancer.
- Conditions
- Prostate Cancer, Prostate Inflammation
- Being tested
- Prostate biopsy
- Medical subject headings
- Prostatic Neoplasms, Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate biopsyProcedure or surgery
Transrectal prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients with diagnosed prostate cancer after TRUS prostate biopsy | Experimental | 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. Receives: Procedure: Prostate biopsy |
| Patients without a prostate cancer diagnosis after TRUS prostate biopsy | Experimental | 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. Receives: Procedure: Prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Measure marker levels in blood samples.
- Investigate links between marker levels and cancer aggressiveness.
- 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.
Measured: 2 weeks
Genetic polymorphism markers' effect on prostate cancer aggressiveness
Genetic Polymorphism Markers' Effect on Prostate Cancer Aggressiveness
Objectives:
- Examine GAS5, JAZF1, CTBP2 polymorphisms and their variations in patients.
- Measure polymorphism levels and their relationship with cancer aggressiveness.
- 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edgaras Burzinskis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edgaras Burzinskis, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505356
- Sponsor's protocol ID
- Nr. BE-2-10
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
- ClinicalTrials.gov ID
- NCT06505356
- Acronym / sponsor ID
- Nr. BE-2-10
- Conditions
- Prostate Cancer, Prostate Inflammation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Edgaras BurzinskisUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Jul 2024 (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.
- 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.
- 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.
- Determine the significance of GAS5, JAZF1, and CTBP2 gene polymorphisms in the development of prostate cancer.
- Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer.
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:
- TRUS: Transrectal Ultrasound
- A medical imaging technique used to visualize the prostate gland and guide the biopsy needle.
- PSA: Prostate-Specific Antigen
- A protein produced by the prostate gland, elevated levels of which can indicate prostate cancer.
- 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:
- GAS5: Growth Arrest Specific 5
- A long non-coding RNA involved in regulating cell growth and apoptosis, often studied in cancer research.
- JAZF1: JAZF Zinc Finger 1
- A gene associated with various cellular processes, including transcriptional regulation and potentially linked to cancer.
- CTBP2: C-terminal Binding Protein 2
- A protein that functions as a transcriptional co-repressor, playing a role in gene expression regulation and cancer.
- PCR: Polymerase Chain Reaction
- A laboratory technique used to amplify DNA sequences, making it easier to study genetic material in detail.
- NGS: Next-Generation Sequencing
- Advanced sequencing technologies that allow for rapid and detailed sequencing of large amounts of DNA.
Inflammatory Markers:
- 6Ckine (CCL21): Chemokine (C-C motif) ligand 21
- A cytokine involved in the immune response and potentially linked to inflammation in cancer.
- Eotaxin (CCL11): Chemokine (C-C motif) ligand 11
- A chemokine that attracts eosinophils and is associated with allergic responses and inflammation.
- 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.
- IFN gamma: Interferon gamma
- A cytokine critical for innate and adaptive immunity against viral and intracellular bacterial infections and for tumor control.
- IL-2: Interleukin 2
- A cytokine that promotes the growth and differentiation of T cells, important in the immune response.
- IL-6: Interleukin 6
- A cytokine involved in inflammation and infection responses, also linked to cancer progression.
- IL-8 (CXCL8): Interleukin 8
- A chemokine that attracts neutrophils and is involved in the inflammatory response.
- IL-10: Interleukin 10
- A cytokine with anti-inflammatory properties, regulating immune responses.
- IL-18: Interleukin 18
- A cytokine that induces interferon gamma production, playing a role in inflammation and immune responses.
- MIP-3 beta (CCL19): Macrophage Inflammatory Protein 3 beta
- A chemokine involved in immune cell trafficking and inflammatory responses.
- PDGF-BB: Platelet-Derived Growth Factor BB
- A growth factor involved in blood vessel formation and the growth of various cell types.
- TNF alpha: Tumor Necrosis Factor alpha
- A cytokine involved in systemic inflammation and is part of the immune system's response to cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diagnosed prostate cancer after TRUS prostate biopsy | Experimental | Procedure: Prostate biopsyProstate 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. |
| Patients without a prostate cancer diagnosis after TRUS prostate biopsy | Experimental | Procedure: Prostate biopsyExperimental: 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Male patients aged 18 years and older.
- Diagnosis: Patients who are suspected of having prostate cancer based on clinical data and standard diagnostic protocols.
- Disease Stage: Patients at any stage of suspected prostate cancer (localized, locally advanced, or metastatic).
- Consent: Ability and willingness to provide written informed consent.
- Clinical Data Availability: Availability of comprehensive clinical data.
Key exclusion criteria (11 listed)
- Prior Treatment: Patients who have undergone any prior prostate cancer treatments such as surgery, radiation therapy, or systemic therapies (e.g., hormone therapy, chemotherapy).
- Other Malignancies: Presence of other concurrent malignancies, except for adequately treated basal cell or squamous cell skin cancer.
- 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).
- Infection: Active infections or other severe medical conditions that could compromise patient safety or study integrity.
- 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.
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 biopsyTransrectal prostate biopsy | Procedure or surgery | Patients with diagnosed prostate cancer after TRUS prostate biopsy, Patients without a prostate cancer diagnosis after TRUS prostate biopsy |
Primary outcome
Inflammatory markers' effect on prostate cancer aggressiveness
Time frame: 2 weeks
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.
Genetic polymorphism markers' effect on prostate cancer aggressiveness
Time frame: 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate biopsy in people with Prostate Cancer and Prostate Inflammation, run by Edgaras Burzinskis at 1 site in Lithuania.
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 6 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Inflammatory markers' effect on prostate cancer aggressiveness (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 13 Mar 2025.