UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prophylactic efficacy of Pegfilgrastim on the risk of febrile pneutropenia treated with Cabazitaxel after Docetaxel-resistant in patients with castration-resistant prostate cancer
Title of the study (Brief title)	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	Hatachi Yukimasa
Organization	Kobe City Medical Center General Hospital
Division name	Medical oncology
Address	2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, Japan
TEL	078-302-4321
Email	yukimasa@kcho.jp

Public contact
Name of contact person	Yukimasa Hatachi
Organization	Kobe City Medical Center General Hospital
Division name	Medical oncology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020453