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Trial Title:
Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
NCT ID:
NCT05832736
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Robotic hemi-prostatectomy with urethral preservation
Description:
Robotic hemi-prostatectomy with urethral preservation
Arm group label:
Patients with unilateral prostate cancer
Other name:
Partial prostatectomy
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).
Criteria for 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.
Gender:
Male
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione del Piemonte per l'Oncologia
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Enrico Checcucci
Phone:
+39 011 9933921
Email:
checcu.e@hotmail.it
Start date:
April 12, 2023
Completion date:
October 2028
Lead sponsor:
Agency:
Fondazione del Piemonte per l'Oncologia
Agency class:
Other
Source:
Fondazione del Piemonte per l'Oncologia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832736
