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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007729
Receipt No. 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 2015/05/12

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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 &#8805;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
Email

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
Email

Sponsor
Institute SaKK
Institute
Department

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
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

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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
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
2015 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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