UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013514 |
|---|---|
| Receipt number | R000015754 |
| Scientific Title | The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade. |
| Date of disclosure of the study information | 2014/03/27 |
| Last modified on | 2014/09/05 07:38:46 |
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Basic information
Public title
The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.
Acronym
The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.
Scientific Title
The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.
Scientific Title:Acronym
The evaluation of the efficacy of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during 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 of a switch from GnRH agonist to GnRH antagonist in prostate cancer patients who relapsed during combined androgen blockade.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the percentage of patients showing decreasing or stable PSA (relative change from baseline of less than 10%) after 12 weeks of GnRH antagonist treatment
Key secondary outcomes
1. the percent change of PSA from baseline at 12 weeks and the maximal change at any time
2. PSA progression-free survival (PSA PFS) (PSA progression was defined as an increase in PSA of >=25% and >=2ng/ml above the nadir.)
3. radiographic progression-free survival (radiographic PFS) (progression in soft-tissue lesions was defined using RECIST criteria, and progression in bone was defined as the appearance of a minimum of two new lesions on bone scan.)
4. overall survival
5. changes in testosterone, LH, FSH, TRACP-5b and ICTP levels
6. safety (adverse events)
7. QOL (FACT-P)
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
Patients are switched from GnRH agonist to GnRH antagonist degarelix. Degarelix is administered subcutaneously at an initial dose of 240mg followed by maintenance doses of 80mg every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
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. histologically confirmed adenocarcinoma of the prostate
2. receiving combined androgen blockade with GnRH agonist and a non-steroidal antiandrogen (bicalutamide or flutamide)
3. two consecutive increases in PSA at a minimum of 1-week intervals and PSA value >= 2.0ng/ml
4. castrate testosterone levels (<=0.5ng/ml)
5. ECOG performance status 0-1
6. laboratory requirements
Hb >= 8.0g/dl
WBC >= 3,000/mm3
platelet >= 100,000/mm3
both AST and ALT <= 2.5 x upper limit of normal
serum creatinine <= 2.0 x upper limit of normal
7. Signed informed consent is obtained prior to the entry to this clinical study.
Key exclusion criteria
1. receiving chemotherapeutic agents (including estramustine), corticosteroids, hormone agents except for GnRH agonist and non-steroidal antiandrogens, or investigational drugs
2. patients who never responded to CAB
3. patients with active multiple cancers
4. patients with clinical symptoms such as bone pain and nerve injury as a result of a spinal cord compression
5. prior treatment with local therapy (radical prostatectomy or radiotherapy)
6. patients with severe hepatic dysfunction (Child-Pugh class C)
7. patients with HIV or chronic active hepatitis B/C
8. history of acute myocardial infarction, severe or unstable angina, coronary or peripheral arterial revascularization, symptomatic congestive heart failure, cerebral vascular disease, transient ischemic attacks, or pulmonary embolism within 6 months before registration
9. patients with interstitial pneumonia or past history of interstitial pneumonia
10. patients with a brain tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Hirabayashi |
Organization
Komaki City Hospital
Division name
Urology
Zip code
Address
1-20, Jobushi, Komaki, Aichi 485-8520, JAPAN
TEL
0568-76-4131
hirabayashi-umin@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hirabayashi |
Organization
Komaki City Hospital
Division name
Urology
Zip code
Address
1-20, Jobushi, Komaki, Aichi 485-8520, JAPAN
TEL
0568-76-4131
Homepage URL
hirabayashi-umin@umin.ac.jp
Sponsor or person
Institute
Tokai Urological Clinical Trial Group
Institute
Department
Personal name
Funding Source
Organization
Tokai Urological Clinical Trial Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University
National Hospital Organization Nagoya Medical Center
Social Insurance Chukyo Hospital
Okazaki City Hospital
Chubu Rosai Hospital
Japanese Red Cross Nagoya Daiichi Hospital
Japanese Red Cross Nagoya Daini Hospital
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
小牧市民病院（愛知県）、名古屋大学医学部（愛知県）、国立病院機構名古屋医療センター（愛知県）、社会保険中京病院（愛知県）、岡崎市民病院（愛知県）、中部労災病院（愛知県）、名古屋第一赤十字病院（愛知県）、名古屋第二赤十字病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 09 | 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
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2014 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015754
