Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State

January 24, 2019 updated by: Ipsen

A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Private practice, La Cañada, Paterna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prior treatment before progression to advanced or metastatic disease.
Time Frame: Baseline
Number of participants with each category of treatment.
Baseline
Treatment of advanced or metastatic disease.
Time Frame: Baseline
Number of participants with each category of treatment.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.
Time Frame: Baseline
Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients.
Baseline
Number of CRPC patients with signs and symptoms of metastatic disease.
Time Frame: Baseline
Baseline
Time to castration resistant state after beginning of hormonotherapy.
Time Frame: Baseline
Baseline
Demographic data.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-92-52014-196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe