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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011255
Receipt No. 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

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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
Email 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
Email miyaji@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013128

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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