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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: unilateral intrafascial resection; Procedure: bilateral intrafascial resection; Procedure: bilateral extrafascial resection

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Pengfei Shao, chief physician; Phone Number: +86 13770561625; Email: spf032@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male patients with prostate cancer who are willing to accept nerve-sparing techniques in Retzius-sparing robot-assisted radical prostatectomy, age between 18 to 80.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: unilateral intrafascial resection; 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.	Procedure: bilateral intrafascial resection; 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.	Procedure: bilateral extrafascial resection; Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Pengfei Shao, chief physician, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-SR-394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No