UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032045 |
|---|---|
| Receipt number | 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 | 2024/07/05 17:00:13 |
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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
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
laparone@gmail.com
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
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
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
Main results already published
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
| 2024 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036562
