Modified Radical Prostatectomy for Prostate Cancer Patients With Enlarged Prostate and Severe Lower Urinary Tract Symptoms: a Single-center, Retrospective Study
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Two-step Radical Prostatectomy
- Registration Number
- NCT06347614
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 30
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
The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
Any contraindication of surgery or anaesthesia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Two-step Radical Prostatectomy Two-step Radical Prostatectomy -
- Primary Outcome Measures
Name Time Method Biochemical Recurrence-free Survival 5 years 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.
- Secondary Outcome Measures
Name Time Method Estimated blood loss Intraoperative Defined as all the blood loss counting during the surgery
Continence ContinenceContinence Continence Continence Continence Continence Continence Continence Continence 2 weeks, 1 months, 3 months, 6 months, 12 months after surgery Evaluated with the use of pad per day. Using no more than 1 pad per day is defined as complete continence
Lower urinary tract symptoms 1 months, 3 months, 6 months, 12 months after surgery Evaluated with International Prostatic Symptom Score (IPSS). 1-7: Mild 8-19:Moderate 20-35: Severe
Erectile function 6 months, 12 months and 24 months after surgery 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 dysfunctionPositive surgical margin rate Through study completion, an average of 5 year 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.
Surgical time Intraoperative Defined as the time duration from the incision at the opening to the end of closing the incision
Hospital stay From date of surgery until the date of discharge, an average of 7 days Defined as the time duration between the first day after surgery to the day of discharge
Complication Through study completion, an average of 5 year All the complications which was evaluated relevant to the surgery will be documented and graded by Clavien-Dindo grade system.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China