Safety and Efficacy of Two-step Radical Prostatectomy
Recruiting · NCT05722392 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Two-step Radical Prostatectomy
What this trial is about
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?
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China