Clinical trial NCT06524219: Comparison of Nerve-sparing Techniques in Radical Prostatectomy for Oncological Outcome and Functional Recovery.
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: biochemical recurrence-free rates
timeFrame: 3 years
measure: urinary control rate
timeFrame: day 0, 3 month, 6 month, 1 year
measure: sexual function
timeFrame: 6 month, 1 year
Secondary outcomes:
measure: perioperative complications
timeFrame: perioperation
measure: positive rate of incisal margin
timeFrame: day 0
measure: prostate cancer-specific survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Pengfei Shao, chief physician
role: PRINCIPAL_INVESTIGATOR
References: