Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer

Last updated: September 22, 2023
Sponsor: Fondazione del Piemonte per l'Oncologia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Robotic hemi-prostatectomy with urethral preservation

Clinical Study ID

NCT05832736
IRCC 15/2023
  • Ages > 40
  • Male

Study 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).

Eligibility Criteria

Inclusion

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 recommendationsand reported according to PiRads V.2) or PET-PSMA (performed according to therecommendations of the EANM and reported according to "EANM standardized reportingguidelines v1.0 for PSMA-PET")
  • Histological diagnosis of acinar-type prostate cancer unilateral on target biopsyand/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

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 investigationalendocrine therapies
  • Serious underlying disease or uncontrolled medical condition including active anduncontrolled infections
  • Patients with dementia or psychiatric illness that limit compliance with studyrequirements or that could prevent understanding and/or signing the informed consent.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Robotic hemi-prostatectomy with urethral preservation
Phase:
Study Start date:
April 12, 2023
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Fondazione del Piemonte per l'Oncologia

    Candiolo, TO 10060
    Italy

    Active - Recruiting

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