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

NCT ID: NCT05832736

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2028-10-31

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with unilateral prostate cancer

Patients with unilateral prostate cancer

Group Type: EXPERIMENTAL

Robotic hemi-prostatectomy with urethral preservation

Intervention Type: PROCEDURE

Robotic hemi-prostatectomy with urethral preservation

Interventions

Robotic hemi-prostatectomy with urethral preservation

Robotic hemi-prostatectomy with urethral preservation

Intervention Type: PROCEDURE

Other Intervention Names

Partial prostatectomy

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Francesco Porpiglia

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Porpiglia

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia

Locations

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Porpiglia

Role: CONTACT

francesco.porpiglia@unito.it

+39 011 9933921

Facility Contacts

Enrico Checcucci

Role: primary

checcu.e@hotmail.it

+39 011 9933921

Other Identifiers

IRCC 15/2023

Identifier Type: -

Identifier Source: org_study_id