Prospective Single-Center Randomized Study Of Single-Port Transvesical Partial Prostatectomy Versus High Intensity Focused Ultrasound (HIFU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Recurrence free survival Recurrence free survival
研究概览
简要总结
This study aims to compare the novel single-port robotic partial prostatectomy to High-intensity focused ultrasound (HIFU) in patients with low to intermediate risk localized prostate cancer. These interventions have become acceptable focal therapies prevalent with beneficial oncologic outcomes and therefore need to be examined further.
详细描述
The primary objective is to evaluate the in-field recurrence rates and recurrence free survival - defined as the absence of clinically significant prostate cancer within the treated zone (identified by prostate MRI and subsequent targeted prostate biopsy).
Secondary objectives of interest are:
- Perioperative parameters such as operative time, perioperative complications, analgesic requirement, postoperative hospital stay, foley catheter duration
- Functional outcomes such as time to urinary continence, urinary continence, and erectile dysfunction
- Oncologic outcomes such as biochemical recurrence rates (defined in section 2.1), recurrence free survival, presence of secondary intervention for prostate cancer (HIFU, radiation, surgery, ADT)
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histologically or cytologically: Biopsy-confirmed prostate cancer, stage T1a, T2a, T2b, or T2c prostate cancer using MRI staging, with a region of interest (ROI) PIRADs grade 3 or greater, Serum PSA 10 ng/ml or less, Region of interest on MRI of grade 3 or greater
- •The MRI performed must include at least:
- •A T2-weighted sequence in sections ≤ 4 mm, centered on the prostate and seminal vesicles, at least in the axial plane. Alternatively, a 3D T2-weighted sequence can be realized,
- •A diffusion sequence of ≤ 4 mm slice in the axial plane. An ADC card will be provided and calculated from at least two values of b, the maximum value of b being ≥ 600 s / mm2,
- •A dynamic sequence after gadolinium injection. It will be a sequence of echo T1-weighted gradient of slice ≤ 4 mm, centered on the prostate and seminal vesicles in the axial plane, with or without fat saturation. A first series will be performed without contrast injection, and will be repeated iteratively for the arrival of a bolus of gadolinium chelates. The time resolution (that is to say, the acquisition time of one dynamic series will be ≤ 20 seconds). The number of chained dynamic series is calculated so that the total length of the dynamic acquisition be at least 3 minutes
- •A total dose of 0.1 mmol / kg of gadolinium chelate will be injected at a rate of 3-4 mL / s by using an automatic injector, in a vein of the hand of the forearm or elbow.
- •If necessary, subtracted images are calculated
- •Clinically significant prostate cancer defined as Gleason score 3+4 or less in any core
- •Biopsies for preoperative diagnosis of prostate cancer will have included: At least 12 randomized samples (2 samples per sextant), At least two targeted sampling on each target score MRI ESUR ≥ 3/5
- •Life expectancy greater than 10 years.
- •Age >18 years.
- •Subjects must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with any prior extensive pelvic surgery, pelvic fractures, hemorrhoid, fissure surgery, cardiac pacemaker, or metal prosthesis
- •Prior treatment for prostate cancer such as radiotherapy, focal or hormonal therapy
- •Uncorrected coagulopathy or history of Latex allergy
- •Active soft tissue or urinary infection, indwelling Foley catheter or severe irritative or obstructive symptoms
- •Poor surgical risk (defined as American Society of Anesthesiology score > 3).
- •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 risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.)
- •Prostate size larger than 80 grams.
- •Subjects with prostatic Calcification (>0.5 cc) close to the area to be treated.
- •Subjects with extraprostatic extension or cribriform pattern on biopsy.
- •Subjectes with sexual dysfunction defined as SHIM score < 17
- •Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Transvesical Single Port Robotic Partial Prostatectomy
Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to Prostatectomy. Prostatectomy consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.
干预措施: Transvesical Single Port Robotic Partial Prostatectomy (Procedure)
High-intensity focused ultrasound (HIFU)
Participants will have a multiparametric prostate MRI and diagnostic prostate biopsy with confirmed localized prostate tumor prior to HIFU. HIFU consists of a single treatment. All participants will have a postoperative visit at 3 days after surgery, followed by phone calls at 1 week, 2 weeks and 4 weeks, followed by office visits at 6 weeks, 3 months, 6 months, 9 months, 1 year, 2 years and 3 years. Participants will be followed indefinitely as per standard of care.
干预措施: High-intensity focused ultrasound (HIFU) (Procedure)
结局指标
主要结局
Recurrence free survival Recurrence free survival
时间窗: 1 year after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Recurrence free survival
时间窗: 3 years after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
Recurrence free survival
时间窗: 2 years after treatment
Number of patients with absence of clinically significant prostate cancer on prostate MRI and targeted prostate biopsy
次要结局
- Time to urinary continence(Assessed at each visit for up to 1 year after treatment)
- Postoperative Complications(Within 3 months after treatment.)
- Operative time(At initial treatment (postoperative day 0))
- Postoperative hospital stay(Up to 1 day after initial treatment)
- Secondary interventions(Assessed at the time of clinic visits up to 3 years after treatment.)
- Analgesic requirment(Once at first follow up (up to 7 days after initial treatment))
- Foley catheter duration(Up to 7 days after initial treatment)
- Urinary continence(Assessed at each visit for up to 1 year after treatment)
- Erectile dysfunction(Assessed at each visit for up to 3 years)
- Biochemical recurrence(Assessed at each visit for up to 3 years)