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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01560858
First received: March 20, 2012
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Prior treatment before progression to advanced or metastatic disease. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Number of participants with each category of treatment.

  • Treatment of advanced or metastatic disease. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Number of participants with each category of treatment.


Secondary Outcome Measures:
  • Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients.

  • Number of CRPC patients with signs and symptoms of metastatic disease. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Time to castration resistant state after beginning of hormonotherapy. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Demographic data. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 407
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560858

Locations
Spain
Private practice, La Cañada, Paterna
Valencia, Spain
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Guillermo De la Cruz, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01560858     History of Changes
Other Study ID Numbers: A-92-52014-196
Study First Received: March 20, 2012
Last Updated: June 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014