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Clinical Application of Sequential Anti-infective Strategy Post-Negative Prostate Biopsy in Enhancing Overall Efficacy for Suspected Prostate Cancer: A Clinical Study

Clinical Application of Sequential Anti-infective Strategy Post-Negative Prostate Biopsy in Enhancing Overall Efficacy for Suspected Prostate Cancer: A Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111359
Enrollment
Unknown
Registered
2025-10-30
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected prostate cancer

Interventions

Intervention Group:Anti-infective therapy
Control group:Placebo

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.??Age >=18 years old?? ?? ??; 2.Digital rectal examination (DRE) reveals suspicious prostate nodules; 3.??Suspicious lesions detected by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI)??; 4.??PSA >10 ng/ml; 5.PSA 4–10 ng/ml with abnormal f/t PSA ratio or PSA density (PSAD)??; 6.??Initial prostate biopsy yields negative results??;

Exclusion criteria

Exclusion criteria: 1.Chronic pelvic pain syndrome (CPPS); 2.??Chronic prostatitis; 3.??History of prostate needle biopsy; 4.??Allergy to local anesthetics; 5.??Coagulation disorders; 6.Acute urinary tract infection with fever??; 7.??Internal/external hemorrhoids, perianal or rectal lesions??; 8.??Patients who withdrew informed consent??; 9.??Investigator-assessed ineligibility for study continuation??;

Design outcomes

Primary

MeasureTime frame
total Prostate-Specific Antigen;

Secondary

MeasureTime frame
Hospital Anxiety and Depression Scale (HADS) scoring;Prostate MRI parameters;

Countries

China

Contacts

Public ContactJie Li

Lishui Central Hospital

lijie9783@126.com+86 578 228 5218

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026