Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

NCT04093375 | Not Yet Recruiting DMC

• 1 other identifier: 2019CR101
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Cause-specific survival

  Up to 5 years

• Overall survival

  Up to 5 years

Study Arms (2)

Radical Prostatectomy

EXPERIMENTAL

Patients with locally advanced prostate adenocarcinoma receives Radical Prostatectomy with or without enlarged lymph node dissection

Procedure: Radical Prostatectomy

Radical Radiotherapy

ACTIVE COMPARATOR

Patients with locally advanced prostate adenocarcinoma receives Radical Radiotherapy with adjuvant androgen deprivation therapy

Other: Radical Radiotherapy

Interventions

Radical Prostatectomy PROCEDURE

Radical prostatectomy with or without androgen deprivation therapy

Radical Prostatectomy

Radical Radiotherapy OTHER

Radical Radiotherapy with adjuvant androgen deprivation therapy

Radical Radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead
• Changhai Hospital: collaborator
• Zhejiang University: collaborator
• Sun Yat-sen University: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Tianjin Medical University Second Hospital: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhihua Wang, M.D ass. prof

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihua Wang, M.D ass. prof

CONTACT

8613607195518; zhwang_hust@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share