UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039864 |
|---|---|
| Receipt number | R000045463 |
| Scientific Title | An study of the effect of frailty on prognosis in patients with metastatic prostate cancer |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2023/03/21 09:52:47 |
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Basic information
Public title
Effect of frailty on prognosis in patients with metastatic prostate cancer(FRA-PmC study)
Acronym
Effect of frailty on prognosis in patients with metastatic prostate cancer(FRA-mPC study)
Scientific Title
An study of the effect of frailty on prognosis in patients with metastatic prostate cancer
Scientific Title:Acronym
An study of the effect of frailty on prognosis in patients with metastatic prostate cancer
Region
| Japan |
Condition
Condition
metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between the frailty and prognosis in patients with metastatic prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the effect of frailty on progression-free survival in patients mHNPC and mCRPC.
Key secondary outcomes
Secondary outcomes included safety, overall survival.
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 metastatic prostate cancer who were treated with standard of care
Key exclusion criteria
Not eligible for the standard of care
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University 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
Hirosaki University 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 School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hirosaki University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University School of Medicine
Address
Hirosaki
Tel
0172395091
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 | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/iju.14256
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/iju.14256
Number of participants that the trial has enrolled
96
Results
The overall survival was significantly shorter in patients with G8 <13 than that of>=13.
Results date posted
| 2023 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 04 | Day |
Baseline Characteristics
This observational study included 540 patients with localized (M0) or metastatic (M1) PC who were treated at the Hirosaki University Hospital and Mutsu General Hospital between January 2017 and June 2019. Eligible patients with localized PC and treated by robot-assisted radical prostatectomy (RARP), radiotherapy (RT), or androgen deprivation therapy alone (ADT-alone) depending on eligibility for surgery or patient preference. Eligible patients with metastatic PC were given a standard of care treatment including ADT, ADT plus bicalutamide, ADT plus docetaxel, or ADT plus abiraterone. Patients with PC who could not be evaluated for frailty using the G8 and those with insufficient treatment information were excluded. Treatment options were discussed, and recommendations made at weekly department medical conferences. RARP or RT was recommended as often as possible for patients with localized PC. Section of treatment modalities was by shared decision making.
Participant flow
We assessed frailty by the G8 score. The G8 includes eight items in multiple geriatric assessment domains and was administered at the initial outpatient clinic visit. IADL was assessed by the Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG) index. We evaluated both the G8 and Fried phenotype criteria in 101 of 540 PC patients (19%).
Adverse events
None
Outcome measures
The primary purpose was the prevalence of frailty (G8<=14). Secondary purposes included a comparison of the G8 scores among the disease status and estimation of optimal cutoff G8 scores of M0 and M1 patients. G8 cutoff score was estimated by receiver operating characteristic (ROC) curve analysis and the area under the curve (AUC). Additional secondary endpoint was the influence of G8 score on overall survival. Multivariate logistic regression analysis was performed to identify the optimal cutoff value of frailty for poor overall survival. Exploratory purpose included the association of the G8 score and Fried phenotype criteria for the definition of frailty.
Plan to share IPD
none
IPD sharing Plan description
None
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 | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a part of our prospective observational study (UMIN000025057). We planned to assess the intra-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) after the development of the CGA tool.
In the UC cohort, we planned to evaluate 1) the intra-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) between the radical cystectomy and trimodal therapy in patients with MIBC (FRART-UC study), 3) between the neobladder and non-neobladder in patients with MIBC (FRAUD study), 4) in patients with upper tract urothelial carcinoma (FRAUT study), 5) metastatic urothelial carcinoma who underwent systemic chemotherapy and/or immunotherapy (FRAM-UC study), and 6) the association of baseline frailty and quality of life (FRAQ-UC study).
In the PC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments (FRAPC study), the effect of frailty on safety and oncological outcomes 2) between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study), 3) among the patients with metastatic PC (FRAM-PC study), 4) the association of baseline frailty and quality of life (FRAQ-PC study), and 5) the association of baseline frailty and postoperative pain (FRAP study).
In the RCC cohort, we planned to evaluate 1) the inter-group difference of frailty among the different stages and treatments, the effect of frailty on safety and oncological outcomes 2) in the patients with radical or partial nephrectomy (FRARN study), 2) between in the mRCC patients with molecular targeted therapy and/or immunotherapy(FRARMT study), and 4) the association of baseline frailty and quality of life (FRAQ-RCC). Also, we planned to estimate the gap between chronological and biological age using frailty (FRAGE-GAP study).
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045463
