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

Prostate Cancer Clinical Trial

— Two-step RP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06347614
• Other study ID #: 2021-FXY-042
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Two-step Radical Prostatectomy
The first step was the enucleation of the hyperplastic adenoma, followed by the anterograde radical prostatectomy of residual tissue

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical time	Defined as the time duration from the incision at the opening to the end of closing the incision	Intraoperative
Secondary	Estimated blood loss	Defined as all the blood loss counting during the surgery	Intraoperative
Secondary	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
Secondary	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	2 weeks, 1 months, 3 months, 6 months, 12 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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