Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05832736
Other study ID # IRCC 15/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 12, 2023
Est. completion date October 2028

Study information

Verified date September 2023
Source Fondazione del Piemonte per l'Oncologia
Contact Francesco Porpiglia
Phone +39 011 9933921
Email francesco.porpiglia@unito.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date October 2028
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Robotic hemi-prostatectomy with urethral preservation
Robotic hemi-prostatectomy with urethral preservation

Locations

Country Name City State
Italy Fondazione del Piemonte per l'Oncologia Candiolo TO

Sponsors (1)

Lead Sponsor Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A