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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026068
Receipt No. R000020453
Scientific Title Prophylactic efficacy of Pegfilgrastim on the risk of febrile pneutropenia treated with Cabazitaxel after Docetaxel-resistant in patients with castration-resistant prostate cancer
Date of disclosure of the study information 2017/02/09
Last modified on 2018/02/14

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Basic information
Public title Prophylactic efficacy of Pegfilgrastim on the risk of febrile pneutropenia treated with Cabazitaxel after Docetaxel-resistant in patients with castration-resistant prostate cancer
Acronym PROSPECT study
Scientific Title Prophylactic efficacy of Pegfilgrastim on the risk of febrile pneutropenia treated with Cabazitaxel after Docetaxel-resistant in patients with castration-resistant prostate cancer
Scientific Title:Acronym PROSPECT study
Region
Japan

Condition
Condition castration-resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We would verify the prophylactic efficacy of Pegfilgrastim on the risk of febrile pneutropenia treated with Cabazitaxel after Docetaxel-resistant in patients with castration-resistant prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Incidence of febrile neutropenia in the initial treatment
Key secondary outcomes Incidence of febrile neutropenia through treatments, Incidence of grade 4 febrile neutropenia through all treatments, The hospitalization frequency dur to febrile neutropenia through all treatments, The use frequency of the antibiotic pill through all treatments, response rate of Cabzitaxel, PFS(progression free survival), overall survival

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 Pegfilgrastim by subcutaneous injection within 24-72 hours after Cabazitaxel administration
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.Patients had newly diagnosed and histologically confirmed prostate cancer
2.Serum testosterone levels are less than 50ng/dl by castration or by drug
3.All patients included in this study should have castration-resistant prostate cancer after docetaxel treatment failure or sever adverse events.
4.Patients were age 20 years or older
5.Eastern Cooperative Oncology Group performance status of 0-2
6.Life expectancy could be more than three months.
7.Adequate hematologic, hepatic and renal function as follows:
Neutrophil count 1,500/mm^3 or higher
Haemoglobin level 9.0g/dl or higher
Platelet count 100,000/mm^3 or higher
Serum Total bilirubin level 1.0x the upper limit of normal or lower
Serum aspartate aminotransferase (AST) levels no higher than 1.5 the ULN
Serum alanine aminotransferase (ALT) levels no higher than 1.5 the ULN
Serum creatinine level no higher than 1.5 the ULN
Or Creatinine clearance 50ml/min or higher
8. All patients provided written informed consent.
Key exclusion criteria 1.Bone marrow function falls by the previous treatment by radiation.
2.Patients have a history of radiation therapy by Sm^153 or P^32 within eight weeks after registration, or by Sr^89 or Ra^223 within twelve weeks after registration.
3.Patient who have a history of an operation, radiation or chemotherapy within four weeks after registration.
4.Patients with a peripheral nerve obstacle of grade more than 2.
5.Patients with stomatitis of grade more than 2.
6.Patient with active infection that should be administered antibiotic or anti-fungal agent
7.Patients with other cancers in the past for five years except for early cancer that should be cured.
8.Patients with brain metastasis or meningitis carcinomatosa
9.Patients with a history of hypersensitive reaction to docetaxel, polysorbate80, prednisolone, granulocyte colony-stimulating factor.
10.Patients with a history of serious arrhythmia, angina pectoris, hypertension, diabetes mellitus, congestive heart failure or myocardial infarction within six months. Patients general condition remain unstable even with intensive care.
11.Patients with interstitial pneumonia on chest X-ray.
12.Patients that need a blood transfusion within fourteen day after chemotherapy.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatachi Yukimasa
Organization Kobe City Medical Center General Hospital
Division name Medical oncology
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Email yukimasa@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukimasa Hatachi
Organization Kobe City Medical Center General Hospital
Division name Medical oncology
Zip code
Address 2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL 078-302-4321
Homepage URL
Email yukimasa@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization no funding source
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 09 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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 09 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020453

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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