An IDEAL Phase 2a, Single-arm, Single-center, Prospective Study of Two-step Radical Prostatectomy in the Treatment of Low- to Intermediate-risk Prostate Cancer Concomitant With Severe Benign Prostatic Hyperplasia

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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?

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yonghong Li, M.D.
liyongh@sysucc.org.cn
020-87343656
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2033-02-15
Participants
Target number of participants: 30
Treatments
Two-step Radical Prostatectomy
Two-step Radical Prostatectomy
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov