Back to resultsRobotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer (RETURN)
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robotic hemi-prostatectomy with urethral preservation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
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.
Sites / Locations
- Fondazione del Piemonte per l'OncologiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with unilateral prostate cancer
Arm Description
Patients with unilateral prostate cancer
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT05832736
First Posted
April 3, 2023
Last Updated
September 22, 2023
Sponsor
Fondazione del Piemonte per l'Oncologia
1. Study Identification
Unique Protocol Identification Number
NCT05832736
Brief Title
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
Acronym
RETURN
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione del Piemonte per l'Oncologia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with unilateral prostate cancer
Arm Type
Experimental
Arm Description
Patients with unilateral prostate cancer
Intervention Type
Procedure
Intervention Name(s)
Robotic hemi-prostatectomy with urethral preservation
Other Intervention Name(s)
Partial prostatectomy
Intervention Description
Robotic hemi-prostatectomy with urethral preservation
Primary Outcome Measure Information:
Title
Feasibility of the robotic hemiprostatectomy technique
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Safety of the robotic hemiprostatectomy technique
Description
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.
Time Frame
30 days
Title
Positive Surgical Margins (PSMs) rate
Description
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.
Time Frame
30 days
Title
Biochemical Recurrence (BCR) rate
Description
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.
Time Frame
5 years
Title
Urinary continence after surgery
Description
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.
Time Frame
5 years
Title
Potency recovery after surgery
Description
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).
Time Frame
5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Porpiglia
Phone
+39 011 9933921
Email
francesco.porpiglia@unito.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Porpiglia
Organizational Affiliation
Fondazione del Piemonte per l'Oncologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione del Piemonte per l'Oncologia
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Checcucci
Phone
+39 011 9933921
Email
checcu.e@hotmail.it
12. IPD Sharing Statement
Learn more about this trial
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
We'll reach out to this number within 24 hrs