UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040801 |
|---|---|
| Receipt number | R000046587 |
| Scientific Title | The effect of robotic radical prostatectomy on oncological outcomes and patient reported outcomes in elderly patients (>=75 years old) with prostate cancer: A prospective observational study |
| Date of disclosure of the study information | 2020/06/29 |
| Last modified on | 2022/12/05 22:43:31 |
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Basic information
Public title
The effect of robotic radical prostatectomy on oncological outcomes and patient reported outcomes in elderly patients (>=75 years old) with prostate cancer: A prospective observational study
Acronym
The effect of robotic radical prostatectomy on oncological outcomes and patient reported outcomes in elderly patients (>=75 years old) with prostate cancer: A prospective observational study
Scientific Title
The effect of robotic radical prostatectomy on oncological outcomes and patient reported outcomes in elderly patients (>=75 years old) with prostate cancer: A prospective observational study
Scientific Title:Acronym
The effect of robotic radical prostatectomy on oncological outcomes and patient reported outcomes in elderly patients (>=75 years old) with prostate cancer: A prospective observational study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of robotic surgery on oncological outcomes and health-related quality of life in elderly patients (>=75 yrs old) with prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of oncological outcomes between aged <75 yrs vs. >=75 yrs.
Key secondary outcomes
Comparison of patient reported outcomes and frality between aged <75 y
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Patients with localized prostate cancer treated with robotic radical prostatectomy 2)HRQOL evaluation (EPIC and or SF-8) at baseline, 3, 6, 9, and 12 months after treatment,3) frailty evaluation (G8) at baseline.
Key exclusion criteria
1) Patients with locally advanced (T4 or N+) or metastatic prostate cancer treated with robotic radical prostatectomy 2)without HRQOL and frailty evaluation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Hirosaki Univ
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
Hirosaki
Tel
+81172395091
rinri@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S107814392030630X?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S107814392030630X?via%3Dihub
Number of participants that the trial has enrolled
752
Results
The oncologic outcomes and PROs in select patients with prostate cancer aged>=75 years were feasible and acceptable with RARP.
Results date posted
| 2022 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The present study aimed to evaluate oncologic outcomes, patient-reported outcomes (PROs), and frailty in older adult patients aged >=75 years who underwent robot-assisted radical prostatectomy (RARP).
Participant flow
This retrospective study reviewed the medical records of 752 patients who underwent RARP from July 2011 to May 2020. The PROs were evaluated by Expanded Prostate Cancer Index Composite questionnaire at baseline and 1 year after RARP.
Adverse events
none
Outcome measures
Oncologic outcomes and PROs were compared between the>=75 and 70-74 years groups and between the>=75 and<70 years groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients received Robotic radical prostatectomy. HRQoL (EPIC and/or SF-8) was evaluated at baseline, 3, 6, 9, 12 months after RARP. The primary outcome was to compare oncological outcomes. Secondary and exploratory outcomes included HRQOL and frailty, respectively.
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046587
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