UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001660 |
|---|---|
| Receipt number | R000002003 |
| Scientific Title | Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer |
| Date of disclosure of the study information | 2009/01/27 |
| Last modified on | 2013/01/28 11:10:00 |
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Basic information
Public title
Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer
Acronym
Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer
Scientific Title
Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer
Scientific Title:Acronym
Phase II trial of neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate evaluating PSA failure free survival and safety for locally advanced prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of neo-adjuvant chemohormonal therapy using LHRH agonist and estramustine phosphate for locally advanced prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1. biochemical-progression free survival
2. Safety
Key secondary outcomes
1. Overall survival
2. Cause-specific survival
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 | Maneuver |
Interventions/Control_1
Patients receive neo-adjuvant chemohormonal therapy combining LHRH agonist and estramustine phosphate for 6 months and undergo radical prostatectomy.
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Histologically confirmed adenocarcinoma of the prostate
2) T2cN0M0 or T3N0M0 (UICC2002)
3) Life expectancy of at least 6 months
4) ECOG performance status 0-1
5) Age: 20 - 80
Key exclusion criteria
1) patients with severe co-morbidity including uncontrollable cardiac, cerebral disease.
2) patients with serious liver dysfunction or serious blood disease.
3) patients with gastroenterial ulcer.
4) Patients who had hypersensitivity to Goserelin or Leuprorelin.
5) patients who fall under the followings: AST, ALT and ALP > 2.5 times upper limit of normal (ULN), Serum creatinine > 1.5 times ULN , Leukocyte count < 3,000/uL, Hemoglobin < 10.0g/dL, Platelet count < 75,000/uL
6) Patients with other cancer requiring treatment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikara Ohyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
0172-39-5091
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Koie |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-cho, Hirosaki, 036-8562 Japan
TEL
0172-39-5091
Homepage URL
urology@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2009 | Year | 01 | Month | 27 | 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
| 2008 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 27 | Day |
Last modified on
| 2013 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002003
