Validation of Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Symptomatic (LUTS) Selected Most Probably Low and Intermediate Risk PCa Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
This prospective study aims to validate the clinical outcomes of performing a concomitant trans-perineal prostate biopsy and laser ablation (termed "Bioblation") during a single session. The intervention is designed for symptomatic patients presenting with lower urinary tract symptoms (LUTS) who are highly suspected to have low to favorable intermediate-risk prostate cancer. By combining diagnosis and targeted treatment under local anesthesia, this approach seeks to facilitate early relief of severe symptoms and a rapid return to daily activities. Ultimately, the study evaluates whether this combined procedure decreases the patient's exposure to multiple, temporally separated interventions without compromising oncological safety or efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with severe Lower Urinary Tract Symptoms (LUTS) meeting the following parameters:
- •IPSS score > 20
- •Uroflowmetry flow rate < 10 ml/sec
- •Post-void residual > 150 cc
- •Patients most probably having low to favorable intermediate-risk prostate cancer, defined as:
- •PSA level between 4 and 20 ng/ml
- •MP-MRI showing 3 or fewer focal lesions
- •MP-MRI focal lesions measuring < 1.5 cm
- •International or visiting patients requiring early return to their home country due to professional or personal commitments, provided they can undergo short-term management and follow-up coordination
排除标准
- •Patient PSA level > 20 ng/ml
- •More than 3 focal lesions on MP-MRI
- •Metastatic prostate cancer
- •History of lower urinary tract surgery (e.g., TURP, Laser, urinary diversions, artificial urinary sphincter)
- •History of pelvic radiation therapy or radical pelvic surgery
研究组 & 干预措施
Bioblation Group
Patients with severe lower urinary tract symptoms (LUTS) and suspected low to favorable intermediate-risk prostate cancer undergoing concomitant trans-perineal prostate biopsy and laser ablation in a single session
干预措施: Bioblation (Procedure)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: Baseline, 1, 3, 6, 9, and 12 months post-procedure
The IPSS is a validated questionnaire used to assess the severity of lower urinary tract symptoms (LUTS). The total score ranges from 0 to 35, where 0-7 indicates mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. A decrease in the score indicates an improvement in symptoms.
次要结局
- Change in Maximum Urinary Flow Rate (Q-max)(Baseline, 1, 3, 6, 9, and 12 months post-procedure)
- Change in Post-Void Residual (PVR) Urine Volume(Baseline, 1, 3, 6, 9, and 12 months post-procedure)
- Change in Prostate Volume(Baseline, 1, 3, 6, 9, and 12 months post-procedure)
- Change in Total Serum Prostate-Specific Antigen (PSA)(Baseline, 1, 3, 6, 9, and 12 months post-procedure)
- Incidence of Procedure-Related Complications(Up to 12 months post-procedure)