Contacts

Zhihua Wang, M.D ass. prof

CONTACT

8613607195518 zhwang_hust@hotmail.com

Sponsors

Lead Sponsor

Tongji Hospital

Collaborators

Changhai Hospital
Zhejiang University
Sun Yat-sen University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tianjin Medical University Second Hospital

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•1. 18≤Age ≤75, at the time of randomization.
•2. Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
•3. Tumor stage (T, M, N): according to 2018 NCCN prostate cancer guidelines T3 stage Significant extra-capsular tumor extension M0 (no sign of distant metastases) Nx (regional lymph nodes cannot be assessed). For patients with T4, the tumor should be confined to the bladder neck, and bilateral ureters should not be invaded.
•4. WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
•5. At least 5 years life expectancy.
•6. The general condition and mental status of patients shall permit observation in accordance with the study protocol.
•7. Signed Informed consent.

Exclusion Criteria

•1. Concomitant with other malignancies.
•2. With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
•3. Clinical significant abnormal laboratory values at the discretion of the investigator, e.g. severe kidney function GFR \< 30 ml/ml or elevated liver transaminases above \> 10 ULN.
•4. Involved in other clinical trials simultaneously.
•5. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

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What this study is about

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