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Trial Title:
Safety and Efficacy of Two-step Radical Prostatectomy
NCT ID:
NCT05722392
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Two-step Radical Prostatectomy
Description:
The first step is enucleation of the hyperplastic adenoma, and the second step is
anterograde RP to residual gland
Arm group label:
Two-step Radical Prostatectomy
Summary:
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?
Criteria for eligibility:
Study pop:
Low- to intermediate-risk localized prostate patient with enlarged prostate and severe
benign prostatic hyperplasia
Sampling method:
Probability Sample
Criteria:
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
Gender:
Male
Gender based:
Yes
Gender description:
Male with prostate cancer
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yonghong Li, M.D.
Phone:
+020-87343656
Email:
liyongh@sysucc.org.cn
Contact backup:
Last name:
Fangjian Zhou, M.D.
Phone:
+020-87343656
Email:
zhoufj@sysucc.org.cn
Start date:
February 15, 2023
Completion date:
February 15, 2033
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05722392
