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

NCT ID: NCT06524219

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2029-10-01

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

unilateral intrafascial resection

Subjects whose preoperative MRIs indicate the lesions are located in the peripheral zone of one side near the capsule, unable to be performed intrafascial resection, and no major lesion or only slight lesion in the peripheral zone of the other side, are going to be conducted unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.

unilateral intrafascial resection

Intervention Type: PROCEDURE

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

bilateral intrafascial resection

Subjects who have low or median-risk tumors and no extracapsular extension for major lesion, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.

bilateral intrafascial resection

Intervention Type: PROCEDURE

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

bilateral extrafascial resection

Subjects who have major lesion that is in the peripheral zone, MRIs that show that the lesion may invade or locate at the edge of the transitional zone, and Gleason score of 4+4 or greater, are going to be conducted bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy.

bilateral extrafascial resection

Intervention Type: PROCEDURE

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

Interventions

unilateral intrafascial resection

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

Intervention Type: PROCEDURE

bilateral intrafascial resection

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

Intervention Type: PROCEDURE

bilateral extrafascial resection

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pengfei Shao, chief physician

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Pengfei Shao, chief physician

Role: CONTACT

spf032@hotmail.com

+86 13770561625

Other Identifiers

2024-SR-394

Identifier Type: -

Identifier Source: org_study_id