Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
Recruiting · NCT05832736 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →Interventions studied
Robotic hemi-prostatectomy with urethral preservation
What this trial is about
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).
Who can take part
Age range
40 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Fondazione del Piemonte per l'Oncologia - Candiolo, TO, Italy