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

Fondazione del Piemonte per l'Oncologia

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Procedure: Robotic hemi-prostatectomy with urethral preservation

Study type

Interventional

Funder types

Other

Identifiers

NCT05832736

IRCC 15/2023

Details and patient eligibility

About

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).

Enrollment

36 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.