Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

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.

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

radical prostatectomy

Procedure

Radical prostatectomy with or without androgen deprivation therapy

Radical Radiotherapy

Other

Radical Radiotherapy with adjuvant androgen deprivation therapy

Primary outcomes

Cause-specific survival

Time frame: Up to 5 years
Overall survival

Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihua Wang, M.D ass. prof

CONTACT

[email protected]

8613607195518

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

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

Registry information

Official study title

Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2026
First posted: Sep 18, 2019
Registry last updated: Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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