Safety and Efficacy of Two-step Radical Prostatectomy

Recruiting now

Conditions studied: Prostate Cancer

In brief

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?

Key facts

Study ID

NCT05722392

Run by

Sun Yat-sen University

People needed

30

Starts

2023-02-15

Expected to finish

2033-02-15

Last updated by the study team

2023-02-10

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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