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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006736
Receipt No. R000007926
Scientific Title A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.
Date of disclosure of the study information 2011/11/16
Last modified on 2014/05/26

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Basic information
Public title A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.
Acronym CRPC with BM/ZOL-CTC Study
Scientific Title A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.
Scientific Title:Acronym CRPC with BM/ZOL-CTC Study
Region
Japan

Condition
Condition Castration resistant prostate cancer
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is the aim of this prospective, single arm, open-label clinical study to investigate the effect of zoledronic acid given every 4 weeks for 3 months on circulating tumor cells in patients with castration resistant prostate cancer with bone metastases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid
Key secondary outcomes *Relationship between PSA and course of CTCs
*Proportion of patients with stable or decreased CTCs at 12 weeks
*Proportion of patients with stable CTCs at 12 weeks
*Analysis of patients based on baseline CTCs (Proportion of patients with stable or decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with stable or decreased CTCs below 5 CTCs at baseline)
*Analysis of patients based on baseline CTCs (Proportion of patients with decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with decreased CTCs below 5 CTCs at baseline)
*Time until decrease of CTCs
*Safety and Tolerability (adverse events, serious adverse events )

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 All patients will be treated with zoledronic acid (dosage according to calculated creatinine clearance before first administration of zoledronic acid) administered as a 15-minute infusion every 4 weeks for 3 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) Histologically proven carcinoma of the prostate with evidence of at least one cancer related bone lesion with castration resistant prostate cancer (2 or more consecutive rising PSA values determined in 2 or more weeks interval).
2) No changes in antitumoral treatment planned through the course of study.
3) Prior surgery, chemotherapy and radiotherapy of metastases (including therapeutic radioisotopes such as strontium 89) is allowed. At least 2 months must have elapsed after completion of surgery, chemotherapy and radiotherapy.
4) Patients with presence of CTCs
5) Performance status ECOG 0-2
6) Laboratory requirements:
a) hepatic function: total bilirubin less than 2,5 times the upper-normal limit of the institution, b) AST, ALT less than 2,5 times the upper-normal limit of the institution.
c) Renal function: creatinine clearance more than 30 ml/min
Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
CrCl= [140-age (years)] x weight (kg) }
[72 x serum creatinine (mg/dL)]
7) Life expectancy more than 6 months
8) Signed informed consent prior to trial entry
Key exclusion criteria 1) Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid
2) Prior treatment with antiresorptive agent (e.g. RANK ligand inhibitor)
3) Patients with proven brain metastases
4) History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
5) Patients with need of treatment for osteoporosis (defined according to DXA, lumber spine BMD T-Score less than 2.5).
6) Patients with NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG
7) Patients with clinically significant ascites
8) Known hypersensitivity to zoledronic acid or other bisphosphonates
9) Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl) or more than 12.0 mg/dl
10) Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more than 5 yrs.
11) Current active dental problems including infection of the teeth or jawbone
12) Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
13) Any change in therapy within the last 2 months (Chemotherapy, change in hormonal therapy)
14) Known history or present abuse of alcohol or drugs
15) Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Horie, M.D.
Organization Teikyo University, School of Medicine
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan, 173-8605
TEL 03-3964-2497
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisamitsu Ide, M.D.
Organization Teikyo University, School of Medicine
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku, Tokyo, Japan, 173-8605
TEL 03-3964-2497
Homepage URL
Email hisamit@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University, School of Medicine
Department of Urology
Institute
Department

Funding Source
Organization Novartis Pharma K.K
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 杏林大学病院(東京都)、慶應義塾大学病院(東京都)、札幌医科大学病院(北海道)、日本医科大学病院(東京都)、昭和大学病院(東京都)、がん研有明病院(東京都)、獨協医科大学越谷病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 16 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 Completed
Date of protocol fixation
2011 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 10 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 16 Day
Last modified on
2014 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007926

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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