UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021806 |
|---|---|
| Receipt number | R000025146 |
| Scientific Title | Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/10/15 18:15:54 |
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Basic information
Public title
Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer
Acronym
Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer
Scientific Title
Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer
Scientific Title:Acronym
Study of the difference in clinical efficacy by the difference between the GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized intermediate-risk prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is to examine the clinical efficacy difference by differences in GnRH agonist and GnRH antagonist when adding short-term androgen deprivation therapy to definitive radiation therapy for localized prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freedom from biochemical progression
Key secondary outcomes
Castration achievement rate (testosterone value 50ng / ml, 20ng / ml) after 1 month, 3 months, and 6 months of androgen deprivation therapy
Normalization of serum testosterone levels after completion of androgen deprivation therapy
Adverse event evaluation using CTCAE ver. 4.0
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
goserelin acetate is administered subcutaneously in the abdomen once every 4 weeks at a dose of 3.6 mg.
Interventions/Control_2
The initial dose of degarelix is 240 mg given as 2 subcutaneous injections of 120 mg in the abdomen. After the initial dose, the maintenance dose of 80 mg is given as one subcutaneous injection in the abdomen every 4 weeks.
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) Be a definitive histological diagnosis of PCa by needle biopsy
2) Have intermediate-risk localized PCa as follows. cT2b -T2c or Gleason score: 7, or PSA 10-20 ng/ml
3) Recieved written informed consent prior to initiating this clinical study
Key exclusion criteria
1) Have previously received hormonal therapies including GnRH agonists, GnRH antagonists, and antiandrogen agents, estorogen agents or orchiectomy for PCa
2) Be using 5alpha reductase inhibitor
3) Have severe asthma (e.g. use inhaled corticosteroid that is necessary for daily life), anaphylactic reaction, severe urticaria and complication or medical history of angioedema
4) Be sensitive to mannitol
5) Have multiple malignancies
6) Have myocardial infarction, unstable angina, congestive heart failure, a history of symptomatic peripheral vascular disease within 12 months prior to incorporation
7) Have a history of cerebrovascular disorders, including transient ischemic attack (TIA)
8) Have ALT>= 100 IU/L or total bilirubin >= 1.3 mg/dL
9) Be considered as inappropriate by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine
Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL
+81-25-777-3200
nisiyama@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Nishiyama |
Organization
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Division name
Department of Urology
Zip code
Address
Urasa 4132, Minamiuonumashi, Niigata 949-7302, Japan.
TEL
+81-25-777-3200
Homepage URL
nisiyama@med.niigata-u.ac.jp
Sponsor or person
Institute
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Uonuma Institute of Community Medicine Niigata University Medical and Dental Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
This study was judged to be difficult to establish as a study from the statistical side.
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
Terminated
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2016 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025146
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| Registered date | File name |
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