UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010765 |
|---|---|
| Receipt number | R000012586 |
| Scientific Title | Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study |
| Date of disclosure of the study information | 2013/05/20 |
| Last modified on | 2018/05/24 13:51:18 |
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Basic information
Public title
Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Acronym
Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Scientific Title
Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Scientific Title:Acronym
Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To see additive effects of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: time to progression, SRE rate, PSA response, adverse effects, etc, comparing with historical controls without bone-modifying agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
1) SRE rate
2) Time to the first SRE
3) PSA response
4) Changes in ALP, BAP, serum NTx, TRAP-5b
5) Adverse effects
6) Changes in bone scan index
7) Changes in bone mineral density
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4mg zoledronic acid will be administered at three-month intervals until becoming a castration resistant prostate cancer.
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) Signed informed consent is obtained prior to the entry to this clinical study.
2) Patients with histologically confirmed adeno-
carcinoma of the prostate.
3) Patients with radiologic evidence of bone metastasis.
4) Treatment-naive prostate cancer patients.
5) Age is >=20 years old.
6) Performance status ECOG 0~2 including performance status 3~4 accompanied by symptoms only due to bone metastasis.
7) Laboratory requirements
a) WBC >=3000/mm3 or neutrophil >=1500/mm3
b) Hemoglobin >=9.0g
c) Platelet >=100000/mm3
d) Total bilirubin <=1.5 times of upper limit of normal
e) AST and ALT <=2.5 times of upper limit of normal
f) serum Creatinine <=2.0mg/dL
g) serum Calcium (adjusted) >=8.0mg/dL
Key exclusion criteria
Patients
1) do not meet the inclusion criteria.
2) have an allergy to bisphosphonates including zoledronic acid.
3) required an urgent radiation therapy for bone metastasis based on symptoms described below: unmanageable pain, spinal cord paralysis, etc.
4) have a treatment history with a bisphosphonate (excluding bisphosphonates taken orally).
5) have an uncontrollable pleural or pericardial effusion.
6) have a brain metastasis with symptoms.
7) have a heavy infection.
8) under or planned an invasive dental treatment.
9) have an interstitial pneumonitis or pulmonary fibrosis.
10) have an active cancer except prostate cancer: cancer free duration <= 3 years.
11) have a myocardial infarction within 6 months.
12) have severe complications: cardiovascular disease, hepatic dysfunction, or coagulation disorders, etc.
13) have mental disorders or neurological symptoms.
14) disqualified by a doctor in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Kawakami |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Urology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3673
kawakami@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Yano |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Urology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3673
Homepage URL
yanoaki@saitama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2013 | 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
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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012586
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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