UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001137 |
|---|---|
| Receipt number | R000001094 |
| Scientific Title | Prospective study of prevention of recurrence of prostate cancer with bone metastasis and prevention of bone mineral density decrease by combination therapy with hormonal therapy and zoledronic acid |
| Date of disclosure of the study information | 2010/05/20 |
| Last modified on | 2014/10/31 17:17:54 |
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Basic information
Public title
Prospective study of prevention of recurrence of prostate cancer with bone metastasis and prevention of bone mineral density decrease by combination therapy with hormonal therapy and zoledronic acid
Acronym
Combination of zoledronic acid and hormonal therapy for prostate cancer with bone metastasis
Scientific Title
Prospective study of prevention of recurrence of prostate cancer with bone metastasis and prevention of bone mineral density decrease by combination therapy with hormonal therapy and zoledronic acid
Scientific Title:Acronym
Combination of zoledronic acid and hormonal therapy for prostate cancer with bone metastasis
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether we can extend a period to recurrence of prostate cancer by using zoledronic acid together with hormonal therapy for prostate cancer having bone metastasis prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence free survival, survival time, survival rate
Key secondary outcomes
bone mineral density
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
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
hormonal therapy
Interventions/Control_2
hormonal therapy and zoledronic acid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
We have to satisfy all the following basis.
1)The case that an agreement is obtained in a document about participation of the final examination
2)The case that it is diagnosed as prostate cancer pathologically, and have bone metastasis in bone scintigraphy clearly
3)A case of non-therapy prostate cancer. But we are possible after hormonal therapy initiation for less than 1 month.
4)Case general condition myelic function is maintained a heart / liver / a kidney enough and to satisfy the next condition:
(a) performance status:0-3
(b) WBC: more than 3,000/mm3
(c) Platelet: more than 100,000/mm3
(d) Hb: more than 9 mg/dL
(e) serum ALT (GPT) equal to or less than 3.0 times of institution upper limits of normal
(f)BUN eLess than 30mg/dL equal to or less than 3.0 times of institution upper limits of normal
(g)Less than serum creatinine 3.0mg/dL
(h) Ca:8.5-11.5mg/dL
Key exclusion criteria
1) The person whom we gave bisphosphonate before beginning of dosage
2)The person who performed bone radiotherapy within beginning of dosage three months
3)serum correction Ca value less than 8.0 mg or active cancer except equal or more than 11.6 mg
4)serum creatinine:more than 3.0mg / dL
5) Active cancer except prostate cancer is the patient in less than 3 years
6)The patient having a grave complication
7)In addition, the patient whom we intended for it, and it was judged judgment of a doctor to be inadequate
8)The case that does not fall under criteria for selection of nine case) subject cases with a plan to perform invasive dentist treatment
9)Bisphosphonate, it is a case with anaphylactic medical history
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Mizokami |
Organization
Kanazawa University
Division name
Urology
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2393
mizokami@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Mizokami |
Organization
Kanazawa University
Division name
Urology
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2393
Homepage URL
mizokami@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University, Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University, Department of Urology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Syowa University, Department of Urology
Toho university, Department of Urology
University of Occupational and Environmental Health, Department of Urology
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
| 2010 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Zoledronic acid improved PSA-PFS in PCa patients with GS 8 and more 8 when Zoledronic acid was administarated from initial hormonal treatment.
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
Completed
Date of protocol fixation
| 2006 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 04 | Month | 28 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001094
