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To evaluate the difference among three nerve-sparing techniques(unilateral intrafascial resection, bilateral intrafascial resection, bilateral extrafascial resection) of oncological outcome and functional recovery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | 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 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unilateral intrafascial resection | Procedure | Conducting unilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengfei Shao, chief physician | Contact | +86 13770561625 | spf032@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pengfei Shao, chief physician | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
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| bilateral intrafascial resection | Procedure | Conducting bilateral intrafascial resection in Retzius-sparing robot-assisted radical prostatectomy |
|
| bilateral extrafascial resection | Procedure | Conducting bilateral extrafascial resection in Retzius-sparing robot-assisted radical prostatectomy |
|
| day 0 |
| prostate cancer-specific survival | the survival for prostate cancer | 3 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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