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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Robotic hemi-prostatectomy with urethral preservation

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Porpiglia; Phone Number: +39 011 9933921; Email: francesco.porpiglia@unito.it

Study Locations

• Italy
  • TO
    • Candiolo, TO, Italy, 10060
      • Recruiting
      • Fondazione Del Piemonte Per L'Oncologia
      • Contact: Enrico Checcucci; Phone Number: +39 011 9933921; Email: checcu.e@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with unilateral prostate cancer	Procedure: Robotic hemi-prostatectomy with urethral preservation; Robotic hemi-prostatectomy with urethral preservation; Other Names: Partial prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the robotic hemiprostatectomy technique	Evaluate the safety of the robotic hemiprostatectomy technique in terms of intra and post-operative complications using the Clavien-Dindo classification. The Clavien-Dindo classification evaluates severity of complications in 5 groups: Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions;; Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications;; Grade III: Requiring surgical, endoscopic or radiological intervention (IIIa: Intervention not under general anesthesia; IIIb: Intervention under general anesthesia);; Grade IV Life-threatening complication requiring IC/ICU-management (IVa: single organ dysfunction; IVb: multiorgan dysfunction);; Grade V: Death of a patient.	30 days
Positive Surgical Margins (PSMs) rate	Evaluate the oncological efficacy in terms of Positive Surgical Margins (PSMs) at the final histological examination as rate between cases with Positive Surgical Margins over the total of the specimens analyzed by pathologists.	30 days
Biochemical Recurrence (BCR) rate	Evaluate the oncological efficacy in terms of Biochemical Recurrence (BCR) during the follow-up period as rate between patients with BCR over the total of patients in the study group. The BCR is any rise in the blood level of PSA (prostate-specific antigen) in prostate cancer patients after treatment with surgery or radiation.	5 years
Urinary continence after surgery	Evaluate the functional outcomes in terms of urinary continence during the follow-up period. The urinary continence will be assessed by the net weight of urine collected in the pad over 24 hours (Pad test). This outcome will be shown by the mont after the surgery in which the patient reach the complete continence defined as no urine loss at the Pad test.	5 years
Potency recovery after surgery	Evaluate the functional outcomes in terms of potency recovery during the follow-up period. The potency recovery will be assessed by the International Index of Erectile Function - 5 (IIEF-5) test. This test will be collected every follow-up visit and results will be shown as progression of the IIEF-5 during the 5 years after the surgery. The IIEF-5 contains 5 items and uses the sum scores and cutoff points to categorize the severity of the erectile dysfunction. This scale ranges from 5 points (severe erectile dysfunction) to 25 points (no erectile dysfunction).	5 years

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Francesco Porpiglia, Fondazione Del Piemonte Per L'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRCC 15/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No