Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
研究概览
简要总结
This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.
SECONDARY OBJECTIVES:
I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.
II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical characteristics:
- •Stage T1c or T2a
- •Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by prostate volume in cubic centimeters) < 0.15 ng/ml^3
- •No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:
- •Bone scan if PSA > 20 ng/ml and clinical stage T1c
- •Bone scan if PSA > 10 ng/ml and clinical stage T2
- •Biopsy requirements:
- •Gleason score 7 or less
- •25% or fewer biopsies with cancer
- •At least 12 biopsy cores of the prostate
- •Within 12 months of treatment
- •Imaging requirements:
- •Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of biopsy-detected cancer(s)
- •MRI within 6 months of treatment
- •Karnofsky performance status of at least 70
- •General health is suitable to undergo the planned minimally invasive procedures
- •Risks, benefits, and alternatives discussed with informed consent given
排除标准
- •Previous treatment of prostate cancer with luteinizing hormone releasing hormone (LHRH) agonist/antagonist, chemotherapy, surgery, or radiation
- •Presence of 3 or more visible lesions on MRI
- •High suspicion of seminal vesicle invasion or lymph node metastases on MRI
- •Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or other)
- •Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body surface area (BSA) based on Modification in Diet Renal Disease equation; inability to safely receive gadolinium contrast for MRI
- •History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder, bowel, internal pelvic organs) that compromise MRI image quality
- •Other serious illnesses involving the cardiac, respiratory, central nervous system (CNS), or hepatic organ systems, which would preclude study completion or impede the determination of causality of any complications experienced during the conduct of this study
研究组 & 干预措施
Treatment (LITT)
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
干预措施: Visualase Thermal Therapy (Device)
Treatment (LITT)
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
干预措施: magnetic resonance imaging (Procedure)
结局指标
主要结局
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
时间窗: At 3 months after ablation
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
次要结局
- The Number of Patients With Biopsy Cancer of the Treatment Zone(At 12 months)
- Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)(At 1,3 and 12 months)
- Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)(At 1,3 and 12 months)
- The Total Number of Patients With Any Adverse Events Related to the Treatment(1,3, and 12 month after treatment and up to 12 months)