UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011255 |
|---|---|
| Receipt number | R000013128 |
| Scientific Title | The study of the efficacy of a second line Luteinizing hormone-releasing hormone agonist after prostate cancer biochemical recurrence |
| Date of disclosure of the study information | 2013/07/23 |
| Last modified on | 2019/07/29 10:34:19 |
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Basic information
Public title
The study of the efficacy of a second line Luteinizing hormone-releasing hormone agonist after prostate cancer biochemical recurrence
Acronym
The study of the efficacy of a second line Luteinizing hormone-releasing hormone agonist after prostate cancer biochemical recurrence
Scientific Title
The study of the efficacy of a second line Luteinizing hormone-releasing hormone agonist after prostate cancer biochemical recurrence
Scientific Title:Acronym
The study of the efficacy of a second line Luteinizing hormone-releasing hormone agonist after prostate cancer biochemical recurrence
Region
| Japan |
Condition
Condition
Patients with prostate cancer who received luteinizing hormone-releasing hormone (LH-RH) agonist, had biochemical progression
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated whether rechallenging patients with prostate cancer, who were receiving a LH-RH agonist but had progression, with a different LH-RH agonist (goserelin or leuprolide) would result in a prostate specific antigen response.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The percent prostate specific antigen change after switching luteinizing hormone-releasing hormone agonist therapy at 3 and 6 months
Key secondary outcomes
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Patient with prostate cancer defined by pathological examination
2. Patient with first biochemical failure during hormone therapy
3. Patient age above 20 years or older
4. Performance status grade 0, 1 or 2
5. Chemical laboratory values met predefined criteria
Key exclusion criteria
1. Serum teststerone level above 0.5ng/ml
2. Patient with clinical symptom, bone pain or urinary retention at PSA failure
3. Patient with the treatment history, who was administered both goserelin and leuprolide
4. Patient administered anti-androgen drug as CAB
5. Administeration of estrogen
6. Sytemic administeration of corticosteroid
7. Patient received chemotherapy
8. Patient with severe diabetes
9. Patients with severe psychosis
10. Patients with double cancer
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Miyaji |
Organization
Kawasaki Medical School
Division name
Department of Urology
Zip code
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
miyaji@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Miyaji |
Organization
Kawasaki Medical School
Division name
Department of Urology
Zip code
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
miyaji@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
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
川崎医科大学附属病院（岡山県）、川崎医科大学附属川崎病院（岡山県）、笠岡第一病院（岡山県）、岡山大学病院（岡山県）、岡山労災病院（岡山県）、さとう記念病院（岡山県）、新見中央病院（岡山県）、大杉病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Cohort Study
Management information
Registered date
| 2013 | Year | 07 | Month | 23 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013128
