Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT05832736
- Run by
- Fondazione del Piemonte per l'Oncologia
- People needed
- 36
- Starts
- 2023-04-12
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2023-09-26
Who can join
Age: 40 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Fondazione del Piemonte per l'Oncologia — Candiolo, TO, Italy (enrolling)
Full record on ClinicalTrials.gov
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