Focal Prostate Ablation for Low to Intermediate Grade Cancer Utilizing TULSA Profound System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients free from treatment failure
研究概览
简要总结
This clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with low to intermediate grade prostate cancer. MRI-guided TULSA ablation is a minimally invasive procedure that uses an ultrasound device guided by MRI imaging to deliver high-energy sound waves, producing very high temperature to ablate (destroy) tumor cells in a targeted manner. The MRI-guided TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
详细描述
PRIMARY OBJECTIVE:
I. To perform the TULSA procedure for safety and efficacy outcomes in men aged 45 to 80 years with biopsy-confirmed, National Comprehensive Cancer Network (NCCN) low to intermediate-risk prostate cancer.
SECONDARY OBJECTIVE:
I. To assess patient-reported metrics for quality of life (QOL). II. To assess return to normal activity. III. Compare economic benefit as noted from Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
OUTLINE:
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 45-80 years, with > 10 years life expectancy
- •Biopsy-confirmed, NCCN [Gleason Grade (GG) 1, favorable GG 2 and unfavorable GG3] intermediate-risk prostate cancer
- •Stage =< T2c, N0, M0
- •International Society of Urological Pathology (ISUP) grade group 1, 2, or 3 disease on transrectal ultrasonography (TRUS)-guided biopsy (minimum 8 cores, combination of systematic and MRI fusion-guided) or in-bore biopsy [minimum 3 cores from each Prostate Imaging-Reporting and Data System (PI-RADS) version (v)2 category >= 3 lesion]. Biopsy reported within 12 months of baseline visit, with minimum 6-week interval between biopsy and baseline
- •Prostate specific antigen (PSA) =< 20 ng/mL reported within 3 months of baseline
- •Treatment naive
- •Planned ablation volume < 3.0 cm axial radius from the urethra on mpMRI acquired within 6 months of baseline
排除标准
- •Inability to undergo MRI or general anaesthesia
- •Suspected tumour > 30 mm from the prostatic urethra or < 14 mm from the prostatic urethra
- •Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor on low-dose pelvic computed tomography (CT)
- •Criteria subject to additional review and approval by sponsor. Alternatively, prospective TRUS to query calcifications or susceptibility-weighted MRI if available may be used to assess calcification. Imaging for calcification screening must be dated within 1 year of baseline visit
- •Unresolved urinary tract infection or prostatitis
- •History of proctitis, bladder stones, hematuria, history of acute urinary retention, severe neurogenic bladder
- •Artificial urinary sphincter, penile implant or intraprostatic implant
- •Less than 10 years life expectancy
- •Patients who are otherwise not deemed candidates for radical prostatectomy (RP)
- •Inability or unwillingness to provide informed consent
- •History of anal or rectal fibrosis or stenosis, or urethral stenosis, or other abnormality challenging insertion of devices
研究组 & 干预措施
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: MRI-Guided Transurethral Ultrasound Ablation (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Questionnaire Administration (Other)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Digital Rectal Examination (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Cystoscopy (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Biopsy (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Bone Scan (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: PSMA PET Scan (Procedure)
Treatment (MRI-guided TULSA)
Patients undergo MRI-guided TULSA. Patients may also undergo DRE, cystoscopy, biopsy, bone scan, PSMA PET, and/or mpMRI at screening.
干预措施: Multiparametric Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Proportion of patients free from treatment failure
时间窗: At 24 months post-treatment
Failure is defined as: delivery of any additional intervention for prostate cancer (local or systemic, including adjuvant therapy); or metastatic disease; or prostate cancer-specific death.
Proportion of patients who maintain both urinary continence and erectile potency
时间窗: At 12 months
Continence is defined as 'pad-free' (0 pads/day), and potency is defined as erection firmness sufficient for penetration (Expanded Prostate Cancer Index Composite \[EPIC\]). Two-sided, 95% Pearson-Clopper confidence interval (CI) will be calculated for each intervention arm separately, and the difference in safety outcomes, along with exact 95% two-sided CI will be calculated.
次要结局
- Biochemical failure(Up to 24 months)
- Histologic failure(At 12 months)
- Multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging and Reporting and Data System (PI-RADS) version 2 score for each visible lesion(At 24 months post-treatment)
- Total prostate volume(At 24 months post-treatment)
- Salvage-free survival(Up to 24 months)
- Biochemical failure-free survival(Up to 24 months)
- Histologic failure-free survival(Up to 24 months)
- Metastasis-free survival(Up to 24 months)
- Change in quality of life(Baseline up to 24 months)
- Prostate cancer-specific survival(Up to 24 months)
- Overall survival(Up to 24 months)
- Change in patient-reported genitourinary function(Baseline up to 24 months)
研究者
David A. Woodrum
Principal Investigator
Mayo Clinic