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NCT Number: NCT06524219

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

unilateral intrafascial resection

Procedure

Conducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy

bilateral intrafascial resection

Procedure

Conducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy

bilateral extrafascial resection

Procedure

Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy

Primary outcomes

  1. biochemical recurrence-free rates

    Time frame: 3 years

    the rate of patients who do not have biochemical recurrence

  2. urinary control rate

    Time frame: day 0, 3 month, 6 month, 1 year

    the rate of patients who do not have incontinence

  3. sexual function

    Time frame: 6 month, 1 year

    the rate of patients who do not lose sexual function

Secondary outcomes

  1. perioperative complications

    Time frame: perioperation

    the complications that occur in perioperation

  2. positive rate of incisal margin

    Time frame: day 0

    the rate of patients who have positive incisal margin after the operation

  3. prostate cancer-specific survival

    Time frame: 3 years

    the survival for prostate cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Pengfei Shao, chief physician

CONTACT

[email protected]

+86 13770561625

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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