Micro-ultrasound-Guided Focal Laser Ablation (MicroUSgFLA) Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Primary Outcome 1:
研究概览
简要总结
This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.
详细描述
Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 40-80 years of age.
- •Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
- •PCa clinical stage T1c or T
- •MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
- •Maximum dimension of MRI/MicroUS visible tumour ≤15mm.
- •Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy.
- •Prostate specific antigen (PSA) level < 15 ng/mL.
- •IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure.
- •Life expectancy of greater than 10 years, based on co-morbidity not related to PCa.
排除标准
- •Maximum dimension of MRI/MicroUS visible tumour > 15 mm.
- •Patients medically unfit for focal therapy of the prostate.
- •Patients who are unwilling or unable to give informed consent.
- •Patients who have received androgen suppression therapy.
- •Patients who have received or are receiving chemotherapy for prostate carcinoma.
- •Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment.
- •Patients who have undergone radiation therapy for PCa or to the pelvis.
- •Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies).
- •Patients with a history of non-compliance with medical therapy and/or medical recommendations.
- •Patients who are unwilling or unable to complete the patient self-assessment questionnaires.
- •Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition.
- •Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days.
- •Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)
研究组 & 干预措施
Single-Arm Prospective Clinical Trial
This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.
干预措施: 6 month, prospective, interventional single-arm safety and effectiveness study (Procedure)
Single-Arm Prospective Clinical Trial
This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.
干预措施: The TRANBERG|CLS Thermal therapy (Device)
结局指标
主要结局
Primary Outcome 1:
时间窗: From enrollment to the end of treatment at 6 months.
Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety Measure Description: Number and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer. Unit of Measure: Number of participants
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA
时间窗: From enrollment to the end of treatment at 6 months
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA Time Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility Measure Description: Proportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and/or biopsy. Unit of Measure: Percentage of procedures
次要结局
- Secondary Outcome 1 - Change in PSA Level From Baseline(From enrollment to the end of treatment at 6 months.)
- Secondary Outcome 2: Change in Urinary Function (IPSS Score)(From enrollment to the end of the treatment at 6 months)
- Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)(From enrollment to the end of treatment at 6 months)