Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT) (UROCOR)

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. Identifier: NCT01284608
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : December 24, 2012
Information provided by (Responsible Party):

Brief Summary:
This is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using FRAX model in patients with prostate cancer. The patients will be following for 12 months

Condition or disease
Prostatic Cancer

Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Metabolic syndrome [ Time Frame: 3 months ]
  2. Metabolic syndrome [ Time Frame: 6 months ]
  3. Metabolic syndrome [ Time Frame: 12 months ]
  4. Diabetes [ Time Frame: 3 months ]
  5. Diabetes [ Time Frame: 6 months ]
  6. Diabetes [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Fracture Risk Assessment Tool (FRAx) assessment [ Time Frame: 0 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer patients in androgen-ablaction treatment in urological departments

Inclusion Criteria:

  • Prostate cancer patient requiring androgen-ablation treatment: LHRH analogs, surgical castration, antiandrogen treatment
  • Provision of informed consent prior to conducting any study-related procedure

Exclusion Criteria:

  • Patient involved in a Clinical Trial

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 identifier (NCT number): NCT01284608

Research Site
El Ejido, Almeria, Spain
Research Site
Huercal Overa, Almeria, Spain
Research Site
Merida, Badajoz, Spain
Research Site
El Hospitalet de Llobregat, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Aranda de Duero, Burgos, Spain
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Miranda de Ebro, Burgos, Spain
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Ferrol, Coru?a, Spain
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San Sebastian, Guipuzcoa, Spain
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Palma de Mallorca, Illes Balears, Spain
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Logrono, La Rioja, Spain
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Monforte (casco Urbano), Lugo, Spain
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Alcala de Henares, Madrid, Spain
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Coslada, Madrid, Spain
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Majadahonda, Madrid, Spain
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San Sebastian de Los Reyes, Madrid, Spain
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Antequera, Malaga, Spain
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Vigo, Pontevedra, Spain
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Osuna, Sevilla, Spain
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Reus, Tarragona, Spain
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Baracaldo, Vizcaya, Spain
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Bilbao, Vizcaya, Spain
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Galdakao, Vizcaya, Spain
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Calatayud, Zaragoza, Spain
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Albacete, Spain
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Barcelona, Spain
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Cordoba, Spain
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Granada, Spain
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Guadalajara, Spain
Research Site
Jaen, Spain
Research Site
Madrid, Spain
Research Site
Toledo, Spain
Research Site
Zaragoza, Spain
Sponsors and Collaborators

Responsible Party: AstraZeneca Identifier: NCT01284608     History of Changes
Other Study ID Numbers: NIS-OES-DUM-2010/1
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by AstraZeneca:
metabolic changes
metabolic syndrome
prostatic cancer
risk fracture

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