UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007729 |
|---|---|
| Receipt number | R000009079 |
| Scientific Title | REGISTRY OF TREATMENT PATTERNS IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (mCRPC) WITH PROGRESSION DURING OR AFTER DOCETAXEL-BASED REGIMEN |
| Date of disclosure of the study information | 2012/04/12 |
| Last modified on | 2023/04/20 15:04:31 |
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Basic information
Public title
REGISTRY OF TREATMENT PATTERNS IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (mCRPC) WITH PROGRESSION DURING OR AFTER DOCETAXEL-BASED REGIMEN
Acronym
PROXIMA
Scientific Title
REGISTRY OF TREATMENT PATTERNS IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (mCRPC) WITH PROGRESSION DURING OR AFTER DOCETAXEL-BASED REGIMEN
Scientific Title:Acronym
PROXIMA
Region
| Japan | Asia(except Japan) | South America |
| Europe | Africa |
Condition
Condition
metastatic castration registant prostate cancer
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe treatment patterns of mCRPC patients who received docetaxel-based chemotherapy and have disease progression
Basic objectives2
Others
Basic objectives -Others
To describe:
-Comparison of treatment approach between countries
-Multidisciplinary Team approach for treatment decision
-The characteristics of patients who receive a further line of treatment after docetaxel-based regimen
-Tumor response during docetaxel-based regimen
-Tumor reponse for subsequent treatments
-Type of disease progression during docetaxel based-regimen
-Type of disease progression during subsequent lines of treatment
-Sequence of treatments other than chemotherapy and hormonotherapy
-Progression-free survival and overall survival with different treatment modalities
-QOL in patients who receive a chemotherapy after docetaxel-based regimen (Health status with EQ-5D Questionnaire; FACT-P)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sequence of treatment lines observed during a period of 12 months in patients who received docetaxel-based regimen and have disease progression
Key secondary outcomes
-Physician criteria for therapeutic decision
-Characteristics of patients who receive a further treatment after docetaxel-based regimen
-Tumor response during docetaxel-based regimen
-Tumor reponse for subsequent treatments
-Type of disease progression during docetaxel based-regimen
-Type of disease progression during subsequent lines of treatment
-Sequence of treatments other than chemotherapy and hormonotherapy
-Progression-free survival and overall survival with different treatment modalities
-QOL ( EQ-5D; FACT-P)
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
-Men ≥18 years of age
-Prostate adenocarcinoma
-mCRPC progressing during or after docetaxel-based chemotherapy
-Patient who have given their written consent
Key exclusion criteria
-Patients having already started a new treatment line for mCRPC
-Participation in a clinical study in which study treatment is blinded
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Akaza |
Organization
The University of Tokyo
Division name
Research Center for Advanced Science and Technology,
Zip code
Address
4-6-1 Komaba Meguro-ku Tokyo 153-8904 Japan
TEL
0354525314
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | PROXIMA office |
Organization
Sanofi K.K.
Division name
CSU
Zip code
Address
TEL
03-6301-3730
Homepage URL
Sponsor or person
Institute
SaKK
Institute
Department
Personal name
Funding Source
Organization
SaKK
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline visit:
Patient characteristics including demographics, disease characteristics at inclusion and prostate cancer history
Details of previous docetaxel-based chemotherapy
Response observed during previous docetaxel-based chemotherapy
Type of disease progression
Treatment planned (classes of therapies)
QOL (EQ-5D; FACT-P)
Management information
Registered date
| 2012 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009079
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