UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026068 |
|---|---|
| Receipt number | 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 11:04:17 |
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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
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
yukimasa@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020453
