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Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

NCT04093375 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-10-24

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

PROCEDURE

Radical Prostatectomy

Radical prostatectomy with or without androgen deprivation therapy

OTHER

Radical Radiotherapy

Radical Radiotherapy with adjuvant androgen deprivation therapy

Sponsors & Collaborators

  • Changhai Hospital

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Zhihua Wang, M.D ass. prof · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04093375 on ClinicalTrials.gov