Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
NCT05832736

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

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2023-09-26

36

Participants Needed

1

Research Sites

285 weeks

Total Duration

On this page

AI-Summary

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and consent for use of personal data
  • Prostate Specific Antigen (PSA) less than 20 ng/mL
  • Unilateral organ-confined prostate cancer on MRI or PET-PSMA imaging
  • Histological diagnosis of unilateral acinar-type prostate cancer with ISUP grade less than 3 on biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy of at least 5 years
  • Availability of pre-operative clinical data
  • Willingness to attend follow-up visits as defined by the protocol
  • No retroperitoneal, lymph node, bone, or visceral metastases
  • Eligibility for robot-assisted radical prostatectomy
Not Eligible

You will not qualify if you...

  • Special histological types of prostate cancer
  • PSA greater than 20 ng/mL at diagnosis
  • Inability to undergo MRI or PET-PSMA (e.g., due to pacemaker or claustrophobia)
  • Previous prostate surgery such as TURP or adenomectomy
  • Current treatment with other anti-cancer drugs including investigational endocrine therapies
  • Serious underlying disease or uncontrolled medical conditions including active infections
  • Dementia or psychiatric illness limiting compliance or ability to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, Italy, 10060

Actively Recruiting

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Research Team

F

Francesco Porpiglia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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