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

About this trial
This is an interventional treatment trial for Prostatic Neoplasms
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.
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
NCT ID
NCT04093375
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
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
Learn more about this trial
Radical Prostatectomy Versus Radical Radiotherapy for Locally Advanced Prostate Cancer
We'll reach out to this number within 24 hrs