Clinical trial NCT04093375: Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer
Official title: Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostatic Neoplasms
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Zhejiang University
name: Sun Yat-sen University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Tianjin Medical University Second Hospital
First posted: 2019-09-18
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cause-specific survival
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Zhihua Wang, M.D ass. prof
role: PRINCIPAL_INVESTIGATOR
References: