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
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:
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:
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:
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:
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
PSA: Prostate-Specific Antigen
Gleason Score:
Genetic and Molecular Biology Acronyms:
GAS5: Growth Arrest Specific 5
JAZF1: JAZF Zinc Finger 1
CTBP2: C-terminal Binding Protein 2
PCR: Polymerase Chain Reaction
NGS: Next-Generation Sequencing
Inflammatory Markers:
6Ckine (CCL21): Chemokine (C-C motif) ligand 21
Eotaxin (CCL11): Chemokine (C-C motif) ligand 11
Fractalkine (CX3CL1): Chemokine (C-X3-C motif) ligand 1
IFN gamma: Interferon gamma
IL-2: Interleukin 2
IL-6: Interleukin 6
IL-8 (CXCL8): Interleukin 8
IL-10: Interleukin 10
IL-18: Interleukin 18
MIP-3 beta (CCL19): Macrophage Inflammatory Protein 3 beta
PDGF-BB: Platelet-Derived Growth Factor BB
TNF alpha: Tumor Necrosis Factor alpha
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 →This is the only study on the registry with Edgaras Burzinskis as lead sponsor.
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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.
Exclusion Criteria:
Additional Considerations:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Transrectal prostate biopsy
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
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.
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