Prostate Cancer
Conditions
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.
Interventions
PROCEDUREunilateral intrafascial resection
Conducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
PROCEDUREbilateral intrafascial resection
Conducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
PROCEDUREbilateral extrafascial resection
Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| prostate cancer-specific survival | 3 years | the survival for prostate cancer |
Contacts
Primary ContactPengfei Shao, chief physician
Outcome results
None listed