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

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ClinicalTrials.gov Identifier: NCT00668083
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer

Condition or disease
Prostate Cancer

Study Type : Observational
Estimated Enrollment : 214 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Retrospective Trial on Sequential Hormonal Therapy in Patients
Study Start Date : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Responsible Party: Italy: Ethics Committee, AstraZeneca
ClinicalTrials.gov Identifier: NCT00668083     History of Changes
Other Study ID Numbers: NIS-OIT-CAS-2007/1
First Posted: April 28, 2008    Key Record Dates
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