Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Inflammatory markers' effect on prostate cancer aggressiveness
Study Overview
Brief Summary
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Edgaras Burzinskis
Principal Investigator
Lithuanian University of Health Sciences