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Not yet recruiting NCT06524219

Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.

— Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multi-center, Real-world Study on the Comparison of Different Nerve-sparing Techniques in Retzius-sparing Robot-assisted Radical Prostatectomy for Oncological Outcome and Functional Recovery.

Overview

To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.

Detailed description

Surgery is a common and effective treatment for localized prostate cancer. The main objective of surgical treatment is to remove the tumor completely in order to achieve the goal of cure. Intrafascial nerve-sparing radical prostatectomy is a radical resection of prostate cancer with minimal damage to the nerves and blood vessels.

There are nerves around the prostate that affect sexual function, and damage to these nerves can lead to complications like sexual dysfunction and incontinence. Therefore, how to completely remove the tumor, as far as possible to preserve these nerves, become an important issue in the surgical treatment.

This study is aim to evaluate the different among nerve-sparing strategies, including unilateral intrafascial resection, bilateral intrafascial resection and bilateral extrafascial resection, on oncological outcome and functional recovery, so as to provide clinical evidence for nerve-sparing surgery of prostate cancer via robot-assisted posterior approach.

Interventions

  • Procedure unilateral intrafascial resection
    Conducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
  • Procedure bilateral intrafascial resection
    Conducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
  • Procedure bilateral extrafascial resection
    Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy

Primary outcome measures

  • biochemical recurrence-free rates [Time frame: 3 years]
  • urinary control rate [Time frame: day 0, 3 month, 6 month, 1 year]
  • sexual function [Time frame: 6 month, 1 year]
Secondary outcome measures (3)
  • perioperative complications [Time frame: perioperation]
  • positive rate of incisal margin [Time frame: day 0]
  • prostate cancer-specific survival [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Men aged ≥18 years and ≤80 years;
  • Histologically proven prostate adenocarcinoma with clinical stage < T3(no capsule break)
  • Clinically localized prostate cancer in very low, low, or intermediate risk groups according to National Comprehensive Cancer Network(NCCN) guidelines (2019 v4) ;
  • Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
  • Life expectancy greater than 10 years;
  • Patients who are willing to accept robot-assisted radical prostatectomy after informed existing treatment plan, must sign the informed consent form.

Exclusion criteria

  • Surgeon thinks that the patient has an unresectable disease;
  • patients who have already applied androgen deprivation therapy(ADT);
  • Preoperative images suggest that the local lymph nodes were larger than 2 cm or suggest bone or distant metastasis;
  • Any contraindication;
  • Previous treatment of prostate cancer, including but not limited to surgery, hormone therapy, chemotherapy, radiotherapy, targeted therapy and immunotherapy;
  • Patients with a history of transurethral resection or enucleation of the prostate;
  • Severe systemic disease that may interfere with the data, assessment, or compliance;
  • Patients who are participating in other clinical trials;
  • Refusing to sign the informed consent
  • Patients that are considered to be not suitable to be included by the researchers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06524219 · 2024-SR-394

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗