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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560858
First Posted: March 22, 2012
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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 ]
    Number of participants with each category of treatment.

  • Treatment of advanced or metastatic disease. [ Time Frame: Baseline ]
    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 ]
    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 ]
  • Time to castration resistant state after beginning of hormonotherapy. [ Time Frame: Baseline ]
  • Demographic data. [ Time Frame: Baseline ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01560858     History of Changes
Other Study ID Numbers: A-92-52014-196
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: June 20, 2013
Last Verified: June 2013

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


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