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Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer (Sorse)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668083
First Posted: April 28, 2008
Last Update Posted: December 10, 2010
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:
AstraZeneca
  Purpose
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Hormonal sensitivity to second line treatment for CaP after Bicalutamide [ Time Frame: six months ]

Secondary Outcome Measures:
  • median duration of second and third line treatments; [ Time Frame: six months ]

Estimated Enrollment: 214
Study Start Date: September 2007
Study Completion Date: July 2008
Primary Completion Date: October 2007 (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:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.
Criteria

Inclusion Criteria:

  • non metastatic Prostate Cancer
  • previous treatment with bicalutamide 150mg
  • biochemical relapse/progression

Exclusion Criteria:

  • use of other treatments for Prostate Cancer
  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): NCT00668083


Locations
Italy
Research Site
Acquaviva delle Fonti, Italy
Research Site
Ancona, Italy
Research SIte
Firenze, Italy
Research Site
Matera, Italy
Research Site
Messina, Italy
Research Site
Milano, Italy
Research Site
Monza, Italy
Research Site
Napoli, Italy
Research Site
Pisa, Italy
Research Site
Portogruaro, Italy
Research Site
Roma, Italy
Research Site
Viareggio, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Davide Meani, MD AstraZeneca Medical Dept
  More Information

Responsible Party: Italy: Ethics Committee, AstraZeneca
ClinicalTrials.gov Identifier: NCT00668083     History of Changes
Other Study ID Numbers: NIS-OIT-CAS-2007/1
First Submitted: April 24, 2008
First Posted: April 28, 2008
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
second line
Prostate Cancer
bicalutamide
biochemical relapse/progression in patients with Prostate Cancer treated with bicalutamide 150mg

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents