UMIN-CTR Clinical Trial

Basic information
Public title	The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Acronym	The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Scientific Title	The effect of treatment modality on health-related quality of life in elderly patients with prostate cancer: A prospective observational study
Scientific Title:Acronym	The effect of treatment modality on health-related quality of life in elderly patients 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 treatment modality on health-related quality of life in elderly patients with prostate cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HRQOL comparison: radical prostatectomy vs. radiation therapy in elderly patients (>=75 yrs)
Key secondary outcomes	HRQOL comparison: radical prostatectomy vs. radiation therapy in elderly patients (<75 yrs) Frailty comparison:radical prostatectomy vs. radiation therapy in elderly patients (>=75 yrs)

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 radical prostatectomy or radiation therapy, 2)HRQOL evaluation (EPIC and SF-8) at baseline, 3, 6, 9, and 12 months after treatment,
Key exclusion criteria	1) Patients with locally advanced (T4 or N+) or metastatic prostate cancer treated with radical prostatectomy or radiation therapy, 2) not treated with radical prostatectomy or radiation therapy,and 3)without HRQOL evaluation (EPIC and SF-8) at baseline, 3 and 12 months after treatment.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki Univ
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 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
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	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	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 07 Month 01 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/33353866/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/33353866/
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 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Objective: 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	Materials and methods: 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 younger and older 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 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The primary outcome is to compare HRQOL between surgery and radiotherapy. Secondary and exploratory outcomes are to compare frailty and oncological outcomes between the groups, respectively.

Management information
Registered date	2020 Year 06 Month 17 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=R000046562