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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032045
Receipt No. R000036562
Scientific Title Questionnaire Survey on the Use of Depot Formulation of Leuprorelin Acetate Injection in Patients with Prostate Cancer (QLIPP)
Date of disclosure of the study information 2018/04/01
Last modified on 2020/10/02

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Basic information
Public title Questionnaire Survey on the Use of Depot Formulation of Leuprorelin Acetate Injection in Patients with Prostate Cancer (QLIPP)
Acronym Questionnaire Survey on Leuprorelin use in prostate cancer patients
Scientific Title Questionnaire Survey on the Use of Depot Formulation of Leuprorelin Acetate Injection in Patients with Prostate Cancer (QLIPP)
Scientific Title:Acronym Questionnaire Survey on Leuprorelin use in prostate cancer patients
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To consider preferences of prostate cancer patients and their caregivers, amongst 4 week depot (one-month depot formulation), 12 week depot formulation (three-month depot formulation), and six-month depot formulation
Basic objectives2 Others
Basic objectives -Others Patient reported outcomes on treatment preference
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To consider preferences of prostate cancer patients prescribed six-month depot formulation of Leuprorelin acetate injection and their caregivers, amongst 4 week depot (one-month depot formulation), 12 week depot formulation (three-month depot formulation), and six-month depot formulation, focusing on the following groups.
- Patients who have difficulty visiting hospitals
- Patients with high caregiver burden
- Patients who change planned hospital visits frequently
- Patients with multiple comorbidities at start of treatment
Key secondary outcomes To add consideration on the relationship between patient preference of six-month depot formulations and the following factors: reduction of the frequency of painful injections, reduction of annual medical expenses for prostate cancer treatment, reduction of the frequency of hospital visits, reduction of the burden of the caregiver, reduction of the frequency of consultations with the doctor, reduction of the time of stay at the hospital, improvement of the quality of life.
To consider burdens of caregivers and preference of six-month depot formulations.

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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients must meet all of the inclusion criteria from 1 to 4 below and caregivers must meet the inclusion criterion 5 in order to be eligible to participate in the study.
1. Prostate cancer outpatients who have visited Matsuyama Red Cross Hospital Urology Department more than once
2. Prescribed six-month depot formulation
3. Agree to participate in the study
4. Eligible to read, understand, and answer the questionnaire for patients
5. Caregiver of patient who meet the inclusion criteria above who agree to participate in the study
Key exclusion criteria 1. Patients who have never prescribed luteinizing hormone-releasing hormone (LH-RH) agonist/LH-RH antagonist luteinizing hormone-releasing hormone (LH-RH) agonist/LH-RH antagonist
2. Caregivers of patients who cannot agree to participate in the study
3. Investigators, near relatives of investigators, investigator assistant, or near relatives of investigator assistant.
4. Who were judged clinically that responses to the questionnaire are improper or unsuitable by the principal investigator or collaborating physicians.
5. Who reject the participation of the study
6. Who wish to withdraw after the consent
7. When a false entry is identified
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yano, M.D., Ph.D.
Organization Matsuyama Red Cross Hospital
Division name Department of Urology
Zip code
Address 1 Bankyo-chi, Matsuyama, Ehime 790-8524, Japan
TEL 089-924-1111
Email laparone@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yano, M.D., Ph.D.
Organization Matsuyama Red Cross Hospital
Division name Department of Urology
Zip code
Address 1 Bankyo-chi, Matsuyama, Ehime 790-8524, Japan
TEL 089-924-1111
Homepage URL
Email laparone@gmail.com

Sponsor
Institute Matsuyama Red Cross Hospital
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 松山赤十字病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 Day

Related information
URL releasing protocol None
Publication of results Published

Result
URL related to results and publications http://www.pieronline.jp/content/article/0289-8020/41080/653
Number of participants that the trial has enrolled 127
Results Fifty-seven percent of patients and 65% of caregivers showed a strong preference for the 6M formulation compared with the 3M formulation. There was no difference in the percentage of strong preference between the two groups,
Among caregivers, there was a strong preference for the 6M drug in those who had to accompany their patients to the hospital (p<0.001). T
Results date posted
2020 Year 10 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 08 Month 20 Day
Baseline Characteristics Prostate cancer patients and their caregivers being treated with 6M depot injections of leuprorelin acetate
Participant flow Recruited and IC by a doctor on outpatient visit
Adverse events None
Outcome measures Clinical and patient reported outcomes
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
2018 Year 02 Month 23 Day
Anticipated trial start date
2018 Year 04 Month 03 Day
Last follow-up date
2018 Year 08 Month 07 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 09 Month 04 Day
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information Questionnaire survey on preference of prostate cancer patients and their caregivers, amongst 4 week depot (one-month depot formulation), 12 week depot formulation (three-month depot formulation), and six-month depot formulation

Management information
Registered date
2018 Year 04 Month 01 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036562

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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