Safety and Efficacy of Two-step Radical Prostatectomy
- Conditions
- Prostate Cancer
- Interventions
- Procedure: Two-step Radical Prostatectomy
- Registration Number
- NCT05722392
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- 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 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 Surgical time Intraoperative Defined as the time duration from the incision at the opening to the end of closing the incision
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
Positive 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.
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.
Cancer-specific survival From date of randomization until the date of date of death from cancer, assessed up to 60 months Number of participants who are not dead due to prostate cancer after a specified duration of time
Estimated blood loss Intraoperative Defined as all the blood loss counting during the surgery
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
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 dysfunctionOverall survival From date of randomization until the date of date of death from any cause, assessed up to 60 months Number of participants who are alive after a specified duration of time
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China