UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004406
Receipt number 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 17:37:40

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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 or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



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

Value
https://center6.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