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

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: bilateral extrafascial resection; Procedure: unilateral intrafascial resection; Procedure: bilateral intrafascial resection

• Registration Number: NCT06524219
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Start: 2024-10-01
• Primary Completion: 2029-10-01
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bilateral extrafascial resection	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.
unilateral intrafascial resection	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.
bilateral intrafascial resection	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.

Primary Outcome Measures

Name	Time	Method
biochemical recurrence-free rates	3 years	the rate of patients who do not have biochemical recurrence
urinary control rate	day 0, 3 month, 6 month, 1 year	the rate of patients who do not have incontinence
sexual function	6 month, 1 year	the rate of patients who do not lose sexual function

Secondary Outcome Measures

Name	Time	Method
prostate cancer-specific survival	3 years	the survival for prostate cancer
perioperative complications	perioperation	the complications that occur in perioperation
positive rate of incisal margin	day 0	the rate of patients who have positive incisal margin after the operation