UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007771 |
|---|---|
| Receipt number | R000008981 |
| Scientific Title | Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/04/16 16:37:09 |
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Basic information
Public title
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Acronym
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Scientific Title
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Scientific Title:Acronym
Clinical study to evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who relapsed after combined androgen blockade.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of LH-RH agonist alternative therapy on prostate cancer patients who were receiving combined androgen blockade (CAB) but had progression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PSA response and response duration
Key secondary outcomes
Time to treatment failure (TTTF)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LHRH agonistwill be changed to another LHRH agonist.
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
| 79 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Pathologically proven prostate cancer
2)Performance status 0-2(ECOG)
3)Age<80 years old
4)Patients who satisfy the following
a)WBC>3.0x10000/uL
b)hemoglobin>10.0g/dL
c)platelet>10x100000/uL
d)serum creatinine<2.0mg/dL
e)AST<100U/L
f)ALT<100U/L
5)Written informed consent can be obtained
Key exclusion criteria
1)Patients who have not observed anti-androgen withdrawal syndrome(AWS)
2)Treated with steroid drug
3)Undergone bilateral orchidectomy
4)Treated with chemotherapy
5)Treated with anti-androgen for benign prostate hyperplasia(BPH)
6)Considered inappropriate for this study by physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikinobu Ohtani |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Urology
Zip code
Address
6528 Koibuchi, Kasama-City, Ibaraki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikinobu Ohtani |
Organization
Ibaraki Prefectural Central Hospital
Division name
Department of Urology
Zip code
Address
6528 Koibuchi, Kasama-City, Ibaraki
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Ibaraki Prefecture Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 16 | Day |
Last modified on
| 2012 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008981
