Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic hemi-prostatectomy with urethral preservation.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Procedure Robotic hemi-prostatectomy with urethral preservation
Robotic hemi-prostatectomy with urethral preservation
Primary outcome measures
- Feasibility of the robotic hemiprostatectomy technique [Time frame: Baseline]
Secondary outcome measures (5)
- Safety of the robotic hemiprostatectomy technique [Time frame: 30 days]
- Positive Surgical Margins (PSMs) rate [Time frame: 30 days]
- Biochemical Recurrence (BCR) rate [Time frame: 5 years]
- Urinary continence after surgery [Time frame: 5 years]
- Potency recovery after surgery [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione del Piemonte per l'Oncologia — Candiolo
Identifiers
NCT: NCT05832736 · IRCC 15/2023