UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039866 |
|---|---|
| Receipt number | R000045464 |
| Scientific Title | The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study) |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2022/12/06 12:21:51 |
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Basic information
Public title
The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study)
Acronym
The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study)
Scientific Title
The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study)
Scientific Title:Acronym
The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer (FRART-PC study)
Region
| Japan |
Condition
Condition
localized prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes: The difference of frailty between radical prostatectomy and radiation therapy in patients with localized prostate cancer.
Key secondary outcomes
Secondary outcomes: The effect of frailty on safety and oncological outcomes between the radical prostatectomy and radiation therapy in patients with localized prostate cancer
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
Localized prostate cancer (PC) patients who underwent robotic-radical prostatectomy (RARP)/open prostatectomy or radiatuon therapy
Key exclusion criteria
Metastatic disease, no definitive therapy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Dept. of Urology, 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 | |
| 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
Government offices of other countries
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
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 | 03 | Month | 19 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32684512/
Publication of results
Unpublished
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 | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 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=R000045464
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