Safety and Efficacy of Two-step Radical Prostatectomy

Sun Yat-sen University

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Two-step Radical Prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05722392

2022-FXY-296

Details and patient eligibility

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?

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed as prostate cancer pathologically by prostate biopsy
2. Evaluated as localized prostate cancer by imaging studies
3. Prostate volume>70mL evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging
4. Gleason score≤ 4+3=7
5. Preoperative PSA<20ng/mL
6. Estimated survival> 10 years；
7. Informed consent is obtained from the patient

Exclusion criteria

1. The patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, HIFU, etc.
2. Any contraindication of surgery or anaesthesia

Trial design

30 participants in 1 patient group

Two-step Radical Prostatectomy

Description:

Two-step Radical Prostatectomy

Treatment:

Procedure: Two-step Radical Prostatectomy