Clinical trial NCT05832736: Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 36
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


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.

Primary outcomes:
measure: Feasibility of the robotic hemiprostatectomy technique
timeFrame: Baseline
Secondary outcomes:
measure: Safety of the robotic hemiprostatectomy technique
timeFrame: 30 days
measure: Positive Surgical Margins (PSMs) rate
timeFrame: 30 days
measure: Biochemical Recurrence (BCR) rate
timeFrame: 5 years
measure: Urinary continence after surgery
timeFrame: 5 years
measure: Potency recovery after surgery
timeFrame: 5 years
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia
state: TO
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia
name: Francesco Porpiglia
role: PRINCIPAL_INVESTIGATOR
References: