NCT01560858

Brief Summary

The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

March 20, 2012

Last Update Submit

January 24, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Prior treatment before progression to advanced or metastatic disease.

    Number of participants with each category of treatment.

    Baseline

  • Treatment of advanced or metastatic disease.

    Number of participants with each category of treatment.

    Baseline

Secondary Outcomes (4)

  • Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.

    Baseline

  • Number of CRPC patients with signs and symptoms of metastatic disease.

    Baseline

  • Time to castration resistant state after beginning of hormonotherapy.

    Baseline

  • Demographic data.

    Baseline

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Age ≥ 18 years
  • Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study
  • Patient must give written informed consent before any study related procedure

You may not qualify if:

  • Patients with medical histories lacking data required to evaluate the study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private practice, La Cañada, Paterna

Valencia, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

ES(1)