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The goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. The main questions it aims to answer are: 1. Whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. Whether the oncologic control is promising?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-step Radical Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two-step Radical Prostatectomy | Procedure | The first step was the enucleation of the hyperplastic adenoma, followed by the anterograde radical prostatectomy of residual tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Recurrence-free Survival | Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. Biochemical recurrence was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical time | Defined as the time duration from the incision at the opening to the end of closing the incision | Intraoperative |
| Estimated blood loss | Defined as all the blood loss counting during the surgery |
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Inclusion Criteria:
Diagnosed as prostate cancer pathologically by prostate biopsy Evaluated as localized prostate cancer by imaging studies Prostate volume>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging Gleason score≤ 4+3=7 Preoperative PSA<20ng/mL Estimated survival> 10 years； Informed consent is obtained from the patient
Exclusion Criteria:
The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
Any contraindication of surgery or anaesthesia
Male with prostate cancer
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Low- to intermediate-risk localized prostate patient with enlarged prostate and severe benign prostatic hyperplasia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| Intraoperative |
| Hospital stay | Defined as the time duration between the first day after surgery to the day of discharge | From date of surgery until the date of discharge, an average of 7 days |
| Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence | Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence | 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery |
| Lower urinary tract symptoms | Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe | 1 months, 3 months, 6 months, 12 months after surgery |
| Erectile function | Evaluated with International Index of Erectile Function-5 (IIEF-5).The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction | 6 months, 12 months and 24 months after surgery |
| Positive surgical margin rate | Defined as the proportion of patients with positive surgical margin of the whole prostate and the margin between the hyperplastic adenoma and the residual gland evaluated by pathologists. The location of positive margin will be documented. | Through study completion, an average of 5 year |
| Complication | All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system. | Through study completion, an average of 5 year |
| 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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