Observational Registry of Treatment Patterns in Castrate-... | NCT01076751

Studies
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

NCT01076751

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Feb 14, 2011Estimated

Enrollment

82Actual

Phase

Not provided

Conditions

Prostatic Neoplasms

Interventions

Not provided

Countries

United States
France
Germany
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

delay in recruitment

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Feb 25, 2010

First Submission Date that Met QC Criteria

Feb 25, 2010

First Posted Date

Feb 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2011

Last Update Posted Date

Feb 14, 2011Estimated

Description Module

Brief Summary

Primary Objective:

Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

Describe treatment patterns
Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
Describe economic and patient-reported outcomes

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Label	Type	Description	Intervention Names
CRPC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		At Month 12 or death

Secondary Outcomes

Measure	Description	Time Frame
Sequence of treatment in second-line, third-line		At Month 6 (+/- 2 months), Month 12 or death
Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others		At baseline, Month 6 (+/- 2 months), Month 12 or death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
Patient who have given their written consent

Exclusion criteria:

Current participation in a clinical trial for the second-line treatment of prostate cancer
Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
Patients having already started a second line treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with metastatic castrate-resistant prostate cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey		United States
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided