Prostatic Neoplasms
Conditions
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 comparison with radical radiation treatment with androgen deprivation therapy among patients diagnosed locally advanced prostate cancer. Lack of extensive PSA screening in mainland China, many new cases of prostate cancer are LAPCa. Surgery and/or radiation plus attempted chemotherapy are curative treatment for advanced solid malign tumors to control and eliminate the local and micro metastases. LAPCa is easy to metastasis, relapse and has a poor prognosis. For LAPCa, a single RP approach is generally not the preferred option because it is generally considered that radical surgery is difficult to completely remove the lesion and the long-term prognosis is not ideal. However, androgen deprivation therapy promotes the prognosis of LAPCa with lymph nodes or seminal vesicle metastases and improves the local control rate of tumor. What is more, for early localized prostate cancer, RT has similar efficacy to RP, for advanced tumor RT can not only relieve urinary tract obstruction and other symptoms, but also improve biochemical progression free survival and local oncological control. A randomized clinical trial comparing two multimodal treatment including RP or RT with ADT regimens is therefore warranted.
Interventions
PROCEDURERadical Prostatectomy
Radical prostatectomy with or without androgen deprivation therapy
OTHERRadical Radiotherapy
Radical Radiotherapy with adjuvant androgen deprivation therapy
Sponsors
Changhai Hospital
Zhejiang University
Sun Yat-sen University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tianjin Medical University Second Hospital
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cause-specific survival | Up to 5 years |
| Overall survival | Up to 5 years |
Contacts
Primary ContactZhihua Wang, M.D ass. prof
Outcome results
None listed