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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013514
Receipt No. 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

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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
Email 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
Email hirabayashi-umin@umin.ac.jp

Sponsor
Institute Tokai Urological Clinical Trial Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015754

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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