Safety and Efficacy of Two-step Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2033-02-15

Brief Summary

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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?

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Two-step Radical Prostatectomy

Intervention Type PROCEDURE

The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland

Interventions

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Two-step Radical Prostatectomy

The first step is enucleation of the hyperplastic adenoma, and the second step is anterograde RP to residual gland

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No