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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002822
Receipt No. R000003440
Scientific Title Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy
Date of disclosure of the study information 2009/12/02
Last modified on 2015/06/01

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Basic information
Public title Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy
Acronym Pilot study for randomized clinical trial of androgen deprivation therapy in patients with PSA failure after radical prostatectomy
Scientific Title Pilot study for randomized clinical trial of bicaltamide alone versus bicaltamide plus goserelin acetate in patients with PSA failure after radical prostatectomy
Scientific Title:Acronym Pilot study for randomized clinical trial of androgen deprivation therapy in patients with PSA failure after radical prostatectomy
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine whether bicalutamide alone is equally effective and safety to combined androgen blockade in patients with PSA failure after radical prostatectomy. The aim of this pilot study is to determine numbers of required patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Clinical relapse-free survival
Key secondary outcomes 1.Evaluation of quality of life (EPIC)
2.Rate of adverse events is evaluated based on the NCI-CTCAE (Ver.3)
3.Overall survival
4.Cause specific survival
5.PSA progression free survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are randomized to arm 1 or arm 2 according to age, PSA levels, Gleason score and institutes.
Arm 1. Bicaltamide alone
Daily oral bicaltamide 80 mg for 3 years.
Interventions/Control_2 Arm 2. Combined androgen brockade
LH-RH agonists (goserelin acetate 3.6 mg/month or 10.8 mg/3 months) with daily oral bicaltamide 80 mg for 3 years.
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
85 years-old >=
Gender Male
Key inclusion criteria The subjects must satisfy the following conditions.
1) Patients must be diagnosed as prostate cancer pathologically.
2) Patients must have a PSA level of 1.0 ng/ml after radical prostatectomy.
3) Patients did not receive any prior hormonal therapy as adjuvant or neo-adjuvant setting.
4) Patients must satisfy the followings:
WBC >= 2500/mm3
Lymphocyte >= 1000/mm3
Hb >= 8.0g/dl
Platelet >= 80000/mm3
Serum Creatinine <= 2.5 x upper limit of normal
Total Bilirubin <= 2 x upper limit of normal
5) Patients must be at a score level of 0-1 of performance status (PS) (EOCG)
6) Patients must be more 20 year-old.
7) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Noguchi
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Division of Clinical Research
Zip code
Address 67 Asahi-machi, Kurume,
TEL 0942-31-7989
Email noguchi@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address 67 Asahi-machi, Kurume,
TEL 0942-31-7744
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Cancer Research Center for Innovative cancer therapy,Kurume University School of medicine
Institute
Department

Funding Source
Organization Cancer Research Center for Innovative cancer therapy,Kurume University School of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kurume University
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 久留米大学病院(福岡県) Kurume University Hosptial(Fukuoka)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 02 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
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 01 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003440

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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