Clinical trial · Interventional
Characterization of Microbiological and Genetic Features in Prostate Cancer and Their Association with Disease Stage
Characterization of Microbiological and Genetic Features in Prostate Cancer Patients and Their Associations with Disease Stage and Clinical Presentation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with diagnosed prostate cancer after TRUS prostate biopsy
- description
- 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.
- interventionNames
- Procedure: Prostate biopsy
- type
- EXPERIMENTAL
- label
- Patients without a prostate cancer diagnosis after TRUS prostate biopsy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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 metastatic). 4. Consent: Ability and willingness to provide written informed consent. 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: 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 Malignancies: 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 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.
References
Publications (0)
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