Clinical trial · Interventional
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic hemi-prostatectomy with urethral preservation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with unilateral prostate cancer
- description
- Patients with unilateral prostate cancer
- interventionNames
- Procedure: Robotic hemi-prostatectomy with urethral preservation
Primary outcomes (1)
- measure
- Feasibility of the robotic hemiprostatectomy technique
- timeFrame
- Baseline
- description
- 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
Secondary outcomes (5)
- measure
- Safety of the robotic hemiprostatectomy technique
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available