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?
Study Type
OBSERVATIONAL
Enrollment
30
The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGBiochemical 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
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
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
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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.
Time frame: Through study completion, an average of 5 year
Overall survival
Number of participants who are alive after a specified duration of time
Time frame: 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
Time frame: From date of randomization until the date of date of death from cancer, assessed up to 60 months