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

NCT05832736 | Recruiting

• 1 other identifier: IRCC 15/2023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of the robotic hemiprostatectomy technique

  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

  Baseline

Secondary Outcomes (5)

• Safety of the robotic hemiprostatectomy technique

  30 days

• Positive Surgical Margins (PSMs) rate

  30 days

• Biochemical Recurrence (BCR) rate

  5 years

• Urinary continence after surgery

  5 years

• Potency recovery after surgery

  5 years

Study Arms (1)

Patients with unilateral prostate cancer

EXPERIMENTAL

Patients with unilateral prostate cancer

Procedure: Robotic hemi-prostatectomy with urethral preservation

Interventions

Robotic hemi-prostatectomy with urethral preservation PROCEDURE

Robotic hemi-prostatectomy with urethral preservation

Also known as: Partial prostatectomy

Patients with unilateral prostate cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, 10060, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Francesco Porpiglia

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Porpiglia

CONTACT

+39 011 9933921; francesco.porpiglia@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 27, 2023
• Study Start: April 12, 2023
• Primary Completion: October 1, 2023
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

IT (1)