UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low dose estramustine phosphate against castration-resistant prostate cancer: phase II study
Title of the study (Brief title)	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	Osamu Ogawa
Organization	Kyoto University, Graduate School of Medicine
Division name	Urology
Address	54 Kawaharacho Shogoin Sakyoku Kyoto
TEL	075-751-3337
Email	ogawao@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Takahiro Inoue
Organization	Kyoto University, Graduate School of Medicine
Division name	Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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