NCT01284608

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

January 26, 2011

Last Update Submit

December 21, 2012

Conditions

Keywords

Observationalprospectivemetabolic changesmetabolic syndromediabetesprostatic cancerrisk fracture

Outcome Measures

Primary Outcomes (6)

  • Metabolic syndrome

    3 months

  • Metabolic syndrome

    6 months

  • Metabolic syndrome

    12 months

  • Diabetes

    3 months

  • Diabetes

    6 months

  • Diabetes

    12 months

Secondary Outcomes (1)

  • Fracture Risk Assessment Tool (FRAx) assessment

    0 and 12 months

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer patients in androgen-ablaction treatment in urological departments

You may qualify if:

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

You may not qualify if:

  • Patient involved in a Clinical Trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Research Site

Albacete, Albacete, Spain

Location

Research Site

El Ejido, Almeria, Spain

Location

Research Site

Huercal Overa, Almeria, Spain

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Research Site

Mérida, Badajoz, Spain

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Research Site

Palma de Mallorca, Balearic Islands, Spain

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Research Site

Barcelona, Barcelona, Spain

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Research Site

El Hospitalet de Llobregat, Barcelona, Spain

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Research Site

Sabadell, Barcelona, Spain

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Research Site

Aranda de Duero, Burgos, Spain

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Miranda de Ebro, Burgos, Spain

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Research Site

Córdoba, Cordoba, Spain

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Research Site

Ferrol, Coru?a, Spain

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Research Site

Granada, Granada, Spain

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Research Site

Guadalajara, Guadalajara, Spain

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Research Site

Donostia / San Sebastian, Guipuzcoa, Spain

Location

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Jaén, Jaen, Spain

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Research Site

Logroño, La Rioja, Spain

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Research Site

Monforte (casco Urbano), Lugo, Spain

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Research Site

Alcalá de Henares, Madrid, Spain

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Research Site

Coslada, Madrid, Spain

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Research Site

Madrid, Madrid, Spain

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Research Site

Majadahonda, Madrid, Spain

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Research Site

San Sebastián de los Reyes, Madrid, Spain

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Research Site

Antequera, Malaga, Spain

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Research Site

Vigo, Pontevedra, Spain

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Research Site

Osuna, Sevilla, Spain

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Research Site

Reus, Tarragona, Spain

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Toledo, Toledo, Spain

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Research Site

Barakaldo, Vizcaya, Spain

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Research Site

Bilbao, Vizcaya, Spain

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Research Site

Galdakao, Vizcaya, Spain

Location

Research Site

Calatayud, Zaragoza, Spain

Location

Research Site

Zaragoza, Zaragoza, Spain

Location

MeSH Terms

Conditions

Prostatic NeoplasmsMetabolic SyndromeDiabetes Mellitus

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations