Two-step prostate removal surgery for prostate cancer with an enlarged prostate
Studies two-step prostate removal surgery in men with early prostate cancer.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Two-step Radical Prostatectomy
Key facts
- Where
- Guangzhou, ChinaSee the site
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT05722392
- Record updated
- 10 February 2023
- Original description
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?Read full original descriptionShow less
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
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?
Inclusion: 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: The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc; Any contraindication of surgery or anaesthesia.