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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004406
Receipt No. R000005261
Scientific Title Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Date of disclosure of the study information 2010/10/18
Last modified on 2016/08/28

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Basic information
Public title Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Acronym Low dose EMP against CRPC
Scientific Title Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Scientific Title:Acronym Low dose EMP against CRPC
Region
Japan

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

Objectives
Narrative objectives1 Effectiveness and adverse effects of low dose estramustine phosphate against castration-resistant prostate cancer will be evaluated. Cases were dichotomized between those with and without previous docetaxel chemotherapy at the time of the entry.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes PSA response rate
Key secondary outcomes

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 Oral intake of low dose estramustine phosphate (313.4mg or 156.7mg)
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
85 years-old >
Gender Male
Key inclusion criteria 1) Evidence of progressive disease during androgen deprivation therapy (LHRH analog with or without antiandrogen)(including a trial of anti-androgen withdrawal therapy) according to PCWG1 criteria for phase II trial
2) More than 6 weeks have passed after final antiandrogen therapy (this is not the case with patients who have received antiandrogen therapy less than 6 months)
3) PSA values should be more than 2ng/ml within 4 weeks before enrollment (The most recent data is employed)
4) All patients can be enrolled with or without previous docetaxel treatment
5) At least 4 weeks should be passed after surgery or radiation
6) Patients must have normal organ and marrow functions as defined below:
Absolute white blood cell count greater than or equal to 3000/mcL
Hemoglobin greater than or equal to 9g/dl
Platelets greater than or to 75000/mcL
AST less than or equal to 90IU/L
ALT less than or equal to 100IU/L
Creatinine less than or equal to 2.0mg/dl
7) ECOG performance status 0-2
8) Age greater than or equal to 20 years and less than 85 years at the time of enrollment
9) Patient must be able to understand and willing to sign a written informed consent document.
Key exclusion criteria 1) Patients who have had estramustine phosphate therapy (including other estrogen-based hormone therapy)
2) Patients with malignancy within 5 years except carcinoma in situ or other malignancies limited within visceral mucosa
3) History of phlebitis, pulmonary embolism, intracranial infarction and coronary diseases
4) History of severe heart disease and renal diseases
5) Patients with active peptic ulcer
6) Psychiatric illness that makes it undesirable for the subject to participate in the trial
7) Evidence of any other significant disorder that make it undesirable for enrollment
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Ogawa
Organization Kyoto University, Graduate School of Medicine
Division name Urology
Zip code
Address 54 Kawaharacho Shogoin Sakyoku Kyoto
TEL 075-751-3337
Email ogawao@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Inoue
Organization Kyoto University, Graduate School of Medicine
Division name Urology
Zip code
Address 54 Kawaharacho Shogoin Sakyoku Kyoto
TEL 075-751-3337
Homepage URL
Email takahi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Department account fund
Organization
Division
Category of Funding Organization Self funding
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 18 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
2010 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2015 Year 12 Month 30 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 01 Month 31 Day
Date analysis concluded
2016 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 18 Day
Last modified on
2016 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005261

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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