Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer: a Prospective Idea, Development, Exploration, Assessment and Long-term Follow-up (I.D.E.A.L.) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Feasibility of the robotic hemiprostatectomy technique
研究概览
简要总结
On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.
The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signature of the informed consent and consent to the use of personal data
- •Prostate Specific Antigen (PSA) < 20 ng/mL
- •Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to "EANM standardized reporting guidelines v1.0 for PSMA-PET")
- •Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and/or standard biopsy with ISUP < 3 and ipsilateral on imaging investigations
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Life expectancy ≥ 5 years
- •Availability of the patient's pre-operative clinical data
- •Patients must be available to carry out the follow-up visits defined by the protocol
- •Absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions
- •Patients eligible for robot-assisted radical prostatectomy
排除标准
- •Special histotypes of prostate cancer
- •Patients with PSA > 20 ng/ml at diagnosis
- •Impossibility to perform MRI (with pacemakers, claustrophobia...) or PET-PSMA
- •Previous prostate surgery (TURP, adenomectomy)
- •Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- •Serious underlying disease or uncontrolled medical condition including active and uncontrolled infections
- •Patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and/or signing the informed consent.
结局指标
主要结局
Feasibility of the robotic hemiprostatectomy technique
时间窗: Baseline
Evaluate the feasibility of the robotic hemiprostatectomy technique in both a preclinical and clinical setting as ratio between the number of hemiprostatectomies completed and the total number of prostatectomies performed
次要结局
- Safety of the robotic hemiprostatectomy technique(30 days)
- Potency recovery after surgery(5 years)
- Urinary continence after surgery(5 years)
- Positive Surgical Margins (PSMs) rate(30 days)
- Biochemical Recurrence (BCR) rate(5 years)
研究者
Francesco Porpiglia
Prof.
Fondazione del Piemonte per l'Oncologia