Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study

N/AActive Not RecruitingNCT06347614

Sun Yat-sen University30 enrolled

Overview

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?

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

Two-step Radical ProstatectomyPROCEDURE

The first step was the enucleation of the hyperplastic adenoma, followed by the anterograde radical prostatectomy of residual tissue

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Surgical time

Defined as the time duration from the incision at the opening to the end of closing the incision

Time frame: Intraoperative

Estimated blood loss

Defined as all the blood loss counting during the surgery

Time frame: Intraoperative

Hospital stay

Defined as the time duration between the first day after surgery to the day of discharge

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.