Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer

Официальное название

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

Обзор

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).

Вмешательства

• Процедура Robotic hemi-prostatectomy with urethral preservation
  Robotic hemi-prostatectomy with urethral preservation

Первичные конечные точки

• Feasibility of the robotic hemiprostatectomy technique [Срок оценки: Baseline]

Вторичные конечные точки (5)

• Safety of the robotic hemiprostatectomy technique [Срок оценки: 30 days]
• Positive Surgical Margins (PSMs) rate [Срок оценки: 30 days]
• Biochemical Recurrence (BCR) rate [Срок оценки: 5 years]
• Urinary continence after surgery [Срок оценки: 5 years]
• Potency recovery after surgery [Срок оценки: 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione del Piemonte per l'Oncologia — Candiolo

Идентификаторы

NCT: NCT05832736 · IRCC 15/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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