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临床试验/NCT07557901
NCT07557901Enrolling By Invitation不适用

A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
300
试验地点
1
主要终点
The incidence of post-biopsy infectious complications.

研究概览

简要总结

Prostate biopsy performed through the perineal skin (the area between the testicles and the anus), known as a transperineal biopsy, is currently considered the standard procedure for diagnosing prostate tumors, having replaced the biopsy performed directly through the rectum. A prostate biopsy involves taking small samples of tissue from the prostate in order to confirm or rule out suspicious changes. The reason for this shift is the lower risk of infectious complications. For this type of biopsy, it has not yet been clearly established whether preventive administration of antibiotics is necessary. Existing studies indicate that the incidence of infection is similar even without antibiotic prophylaxis. The aim of the monitoring is to confirm the safety of performing transperineal prostate biopsy without the use of antibiotics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • Suspicion of prostate cancer based on an elevated PSA level and/or findings on prostate MRI and/or a positive finding on digital rectal examination
  • Cognitive ability sufficient to understand and sign informed consent
  • Health status allowing for local anesthesia and a surgical procedure

排除标准

  • Indwelling urinary catheter
  • Active (symptomatic) urinary tract infection
  • Immunodeficiency
  • Use of immunosuppressive therapy
  • Ongoing antibiotic therapy for another reason
  • Uncontrolled diabetes mellitus
  • Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.)
  • Ongoing chemotherapy
  • History of infectious complications following prostate biopsy

研究组 & 干预措施

Antibiotic prophylaxis group

Experimental

The study arm includes patients who received antibiotic prophylaxis for prostate biopsy.

干预措施: Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. (Drug)

NO-Antibiotic prophylaxis group

Experimental

The study arm includes patients who received no antibiotic prophylaxis for prostate biopsy.

干预措施: No antibiotic prophylaxis for prostate biopsy (Diagnostic Test)

结局指标

主要结局

The incidence of post-biopsy infectious complications.

时间窗: At 3 weeks and at 2 months after the procedure

次要结局

未报告次要终点

研究者

发起方
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viktor Kováčik

Mr.

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

研究点 (1)

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