Status:
NOT_YET_RECRUITING
Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Changhai Hospital
Zhejiang University
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
This prospective, open randomized clinical trial seeks to investigate whether radical prostatectomy with androgen deprivation therapy improves prostate-cancer specific survival and quality of life in ...
Eligibility Criteria
Inclusion
- 18≤Age ≤75, at the time of randomization.
- Confirmed as non-metastatic prostate adenocarcinoma by transrectal ultrasound biopsy in six months before enrollment and untreated.
- 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.
- WHO score 0-1, ECOG score 0-2, and ASA grade I-III.
- At least 5 years life expectancy.
- The general condition and mental status of patients shall permit observation in accordance with the study protocol.
- Signed Informed consent.
Exclusion
- Concomitant with other malignancies.
- With severe systemic disease (cardio-cerebrovascular disease, etc.) cannot tolerate surgery or radiotherapy.
- 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.
- Involved in other clinical trials simultaneously.
- Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04093375
Start Date
November 1 2019
End Date
December 31 2026
Last Update
October 24 2019
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