UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011969 |
|---|---|
| Receipt number | R000013979 |
| Scientific Title | Validation study of risk classification in patients with castration-resistant prostate cancer |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2014/05/07 13:05:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation study of risk classification in patients with castration-resistant prostate cancer
Acronym
Validation study of CRPC risk classification
Scientific Title
Validation study of risk classification in patients with castration-resistant prostate cancer
Scientific Title:Acronym
Validation study of CRPC risk classification
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical significance of risk classification for castration-resistant prostate cancer by external validation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival between the risk groups
Key secondary outcomes
Prostate-specific antigen responses between the risk groups
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
-confirmed histological PCa diagnosis
-refractory to androgen deprivation therapy with combined androgen blockade, anti-androgen withdrawal, and anti-androgen substitution
-refractory to estramustine phosphate
-received 2 or more cycles of docetaxel
-obtained written informed consent to participate in this study
Key exclusion criteria
-had insufficient clinical data for risk classification
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Morita |
Organization
Jichi Medical University
Division name
Department of Urology
Zip code
Address
Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
TEL
0285-58-7379
moritatu@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakano |
Organization
Jichi Medical University
Division name
Department of Urology
Zip code
Address
Yakushiji 3311-1, Shimotsuke-city, Tochigi, Japan
TEL
0285-58-7379
Homepage URL
nknkzhk@jichi.ac.jp
Sponsor or person
Institute
Department of Urology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Jichi Medical University
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
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.biomedcentral.com/1471-2490/14/31
Number of participants that the trial has enrolled
Results
Most of castration-resistant prostate cancer patients were classified into good-risk group according to the Armstrong risk classification and the Armstrong risk classification could predict
prognosis in docetaxel-treated castration-resistant prostate cancer patients.
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
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 10 | Day |
Other
Other related information
Castration-resistant prostate cancer patients who received 2 or more docetaxel cycles are selected for this study. The patients are classified into good-, intermediate-, and poor-risk groups according to the Armstrong risk classification. Overall survival and prostate-specific antigen responses are calculated and compared between the risk groups.
Management information
Registered date
| 2013 | Year | 10 | Month | 06 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
