Safety and Efficacy of Two-step Radical Prostatectomy

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patient with enlarged prostate and severe benign prostatic hyperplasia. The main question 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?

Official Title
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An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Two-step Radical Prostatectomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Two-step Radical Prostatectomy<br>Two-step Radical Prostatectomy | Procedure: Two-step Radical Prostatectomy<br>* The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 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 | 
| Overall survival | Number of participants who are alive after a specified duration of time | From date of randomization until the date of date of death from any cause, assessed up to 60 months | 
| Cancer-specific survival | Number of participants who are not dead due to prostate cancer after a specified duration of time | From date of randomization until the date of date of death from cancer, assessed up to 60 months |