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

NCT06505356 | Enrolling By Invitation

• 1 other identifier: Nr. BE-2-10
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Determine the significance of GAS5, JAZF1, and CTBP2 gene polymorphisms in the development of prostate cancer.
4. 4.Evaluate the association of a specific gene polymorphism with the clinical course of the disease in patients with prostate cancer.

Conditions

Prostate Cancer; Prostate Inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• 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.

  2 weeks

Study Arms (2)

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.

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.

Procedure: Prostate biopsy

Interventions

Prostate biopsy PROCEDURE

Transrectal prostate biopsy

Patients with diagnosed prostate cancer after TRUS prostate biopsy; Patients without a prostate cancer diagnosis after TRUS prostate biopsy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: This study includes male participants as defined by their self-identified gender. This approach ensures inclusivity and respects the gender identity of all participants. Participants must have a prostate, which is an organ typically found in males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgaras Burzinskis: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatitis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 17, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

LI (1)