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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010765
Receipt No. 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

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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
Email 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
Email yanoaki@saitama-med.ac.jp

Sponsor
Institute Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012586

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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