Customized Ablation of the Prostate With the TULSA Procedure Against Radical Prostatectomy Treatment: a Randomized Controlled Trial for Localized Prostate Cancer (CAPTAIN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 201
- 试验地点
- 44
- 主要终点
- Efficacy endpoint - proportion of patients free from treatment failure
研究概览
简要总结
Men with localized, intermediate risk prostate cancer will be randomized to undergo either radical prostatectomy or the TULSA procedure, with a follow-up of 10 years in this multi-centered randomized control trial. This study will determine whether the TULSA procedure is as effective and more safe compared to radical prostatectomy.
详细描述
The typical standard of care for patients with localized, intermediate risk prostate cancer is radical prostatectomy, which involves the surgical removal of the prostate. Although radical prostatectomy is effective in terms of controlling the cancer, it may leave men with significant long-term effects in urinary, sexual function like erectile dysfunction and/or incontinence (loss of bladder control), thus reducing quality of life. Preservation of continence (ability to control your bladder) and potency (ability to achieve erection and/or ejaculation) may be significant concerns for men.
Targeted ablation of localized prostate cancer using MRI-guided technology is becoming a favorable option for many men who wish to have their cancer treated but do not wish to compromise their urinary and sexual functions. The TULSA Procedure is a new, minimally-invasive technique that uses real-time MRI-guided technology to guide the delivery of high-energy ultrasound to precisely, and in a customized fashion specific to you, heat and kill the prostate cancer tissue while protecting important surrounding body parts that are important for preserving urinary and sexual function. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like traditional surgery or minimally invasive surgery.
The purpose of this research study is to:
- Test whether the TULSA Study Procedure preserves or improves your quality of life (urinary, bowel and sexual functions) at 12 months post-study treatment compared to standard of care (radical prostatectomy).
- Test how many subjects who undergo the TULSA Study Procedure are free from treatment failure by 3 years post-study treatment compared to subjects who undergo the standard of care (radical prostatectomy). Treatment failure is defined as undergoing other additional prostate cancer treatments, spreading of cancer or death caused by cancer.
About 201 subjects will participate in this study with 67 randomly assigned to the radical prostatectomy group and 134 randomly assigned to the TULSA procedure group. Patients will have a 1 in 3 chance of being assigned to the radical prostatectomy group and a 2 in 3 chance of being assigned to the TULSA group. Following treatment, patients will be followed up for 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 80 years, with >10 years life expectancy
- •NCCN (favorable and unfavourable) intermediate-risk prostate cancer on biopsy acquired within last 12 months
- •Stage ≤cT2c, N0, M0
- •ISUP Grade Group 2 or 3 disease on TRUS-guided biopsy or in-bore biopsy
- •PSA ≤20ng/mL within last 3 months
- •Treatment-naïve
- •Planned ablation volume is < 3 cm axial radius from urethra on mpMRI acquired within last 6 months
排除标准
- •Inability to undergo MRI or general anesthesia
- •Suspected tumor is > 30 mm from the prostatic urethra
- •Prostate calcifications > 3 mm in maximum extent obstructing ablation of tumor
- •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
- •Patients who are otherwise not deemed candidates for radical prostatectomy
- •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
结局指标
主要结局
Efficacy endpoint - proportion of patients free from treatment failure
时间窗: 36 months post-treatment
Compare the proportion of patients experiencing treatment failure, between the 2 arms. 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.
Safety endpoint - proportion of patients who maintain both urinary continence and erectile potency
时间窗: 12 months post-treatment
Compare preservation of urinary continence and erectile potency, between the 2 arms. Urinary continence is defined as 'pad-free' (0 pads/day) (per EPIC question 5) and erectile potency is defined as erection firmness sufficient for penetration (per IIEF question 2).
次要结局
- Metastases-free survival endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- Prostate cancer-specific survival endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- Penile length endpoint(At 1 month and 12 months post-treatment)
- Biochemical failure endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- Histological failure endpoint(At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA)
- mpMRI endpoint (for Tulsa arm only)(At 12 month post treatment, and also at 24 months post treatment for patients who undergo a repeat TULSA)
- Overall survival endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- Blood loss endpoint(During the procedure and immediately after the procedure)
- Salvage-free survival endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- Surgical complications endpoint(At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years)
- Penile rehabilitation endpoint(At the following study visits post treatment: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5 years)
- NRS Endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.)
- Inpatient hospital stay endpoint(Immediately after the procedure)
- Transfusion volume endpoint(During the procedure and immediately after the procedure)
- IPSS Endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- EPIC Endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)
- EQ-5D-5L Endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24, and 36 months.)
- IIEF-15 Endpoint(At each visit post treatment throughout the total study follow up: 1, 3, 6, 9, 12, 18, 24 month, and 3, 4, 5, 6, 7, 8, 9, 10 years)