UMIN-CTR Clinical Trial

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
Email	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
Email	shingorilla2@gmail.com

Sponsor
Institute	Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045464