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

Prostate Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560858
• Other study ID #: A-92-52014-196
• Status: Completed
• Start date: April 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Spain	Private practice, La Cañada, Paterna	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prior treatment before progression to advanced or metastatic disease.	Number of participants with each category of treatment.	Baseline
Primary	Treatment of advanced or metastatic disease.	Number of participants with each category of treatment.	Baseline
Secondary	Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.	Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients.	Baseline
Secondary	Number of CRPC patients with signs and symptoms of metastatic disease.		Baseline
Secondary	Time to castration resistant state after beginning of hormonotherapy.		Baseline
Secondary	Demographic data.		Baseline