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Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radical Prostatectomy
Radical Radiotherapy
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Radical Prostatectomy

    Radical Radiotherapy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Cause-specific survival
    Overall survival

    Secondary Outcome Measures

    Full Information

    First Posted
    September 16, 2019
    Last Updated
    October 22, 2019
    Sponsor
    Tongji Hospital
    Collaborators
    Changhai Hospital, Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Second Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04093375
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tongji Hospital
    Collaborators
    Changhai Hospital, Zhejiang University, Sun Yat-sen University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Second Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Radical Prostatectomy
    Arm Type
    Experimental
    Arm Description
    Patients with locally advanced prostate adenocarcinoma receives Radical Prostatectomy with or without enlarged lymph node dissection
    Arm Title
    Radical Radiotherapy
    Arm Type
    Active Comparator
    Arm Description
    Patients with locally advanced prostate adenocarcinoma receives Radical Radiotherapy with adjuvant androgen deprivation therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    Radical Prostatectomy
    Intervention Description
    Radical prostatectomy with or without androgen deprivation therapy
    Intervention Type
    Other
    Intervention Name(s)
    Radical Radiotherapy
    Intervention Description
    Radical Radiotherapy with adjuvant androgen deprivation therapy
    Primary Outcome Measure Information:
    Title
    Cause-specific survival
    Time Frame
    Up to 5 years
    Title
    Overall survival
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhihua Wang, M.D ass. prof
    Phone
    8613607195518
    Email
    zhwang_hust@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhihua Wang, M.D ass. prof
    Organizational Affiliation
    Tongji Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer

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