UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040266 |
|---|---|
| Receipt number | R000045936 |
| Scientific Title | The effect of frailty on quality of life and lower urinary symptoms after robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL study) |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/12/06 12:19:25 |
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Basic information
Public title
The effect of frailty on quality of life and lower urinary symptoms after robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL study)
Acronym
The effect of frailty on quality of life and lower urinary symptoms after robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL study)
Scientific Title
The effect of frailty on quality of life and lower urinary symptoms after robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL study)
Scientific Title:Acronym
The effect of frailty on quality of life and lower urinary symptoms after robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL study)
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effect of frailty on and health-related quality of life (HRQOL) and lower urinary symptoms (LUTS) after robot-assisted radical prostatectomy (RARP) in patients with prostate cancer (PC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of frailty on HRQOL between the frail and nonfrail groups from the baseline to 12 months after RARP.
Key secondary outcomes
The effect of frailty on LUTS between the frail and nonfrail groups from the baseline to 12 months after RARP.
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
Patients with prostate cancer treated with robot-assisted radical prostatectomy (RARP)
Key exclusion criteria
Patients with prostate cancer treated with radiotherapy or androgen deprivation therapy, and without HRQOL evaluation for 12 months.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
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
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
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
Dept. of Urology, Hirosaki University Graduate School of Medicine
Address
5 Zaifu-chou, 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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32684512/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32684512/
Number of participants that the trial has enrolled
479
Results
The G8 score and comorbidities have a significant effect on surgical contraindication in patients with localized CaP.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To determine how frailty and comorbidities affect surgical contraindication in patients with localized prostate cancer (CaP).
Participant flow
We evaluated the effects of frailty in 479 patients with localized CaP who were treated with robot-assisted radical prostatectomy (RARP), or radiotherapy (RT) eligible for surgery (RT-nonfrail), or those with RT ineligible for surgery due to frailty or comorbidity (RT-frail) from February 2017 to April 2020.
Adverse events
none
Outcome measures
We retrospectively compared the geriatric 8 screening (G8) scores between patients with surgical indications (RARP and RT-nonfrail groups) and those with surgical contraindications (RT-frail group). The effect of G8 score in the RT-frail groups was investigated using multivariate logistic regression analysis. We developed and validated a nomogram for surgical contraindication in patients with localized CaP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | 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
Evaluation of the geriatric 8 screening (G8) scores, SF-8 Health Survey (SF-8), Expanded Prostate Cancer Index Composite (EPIC), International Prostate Symptom Score (IPSS), and Overactive Bladder Symptom Score (OABSS) for 12 months.
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045936
