Clinical trial NCT01284608: Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
Official title: Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Cancer
Keywords: Observational
prospective
metabolic changes
metabolic syndrome
diabetes
prostatic cancer
risk fracture
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 197
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients in androgen-ablaction treatment in urological departments

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


Eligibility criteria: 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

Primary outcomes:
measure: Metabolic syndrome
timeFrame: 3 months
measure: Metabolic syndrome
timeFrame: 6 months
measure: Metabolic syndrome
timeFrame: 12 months
measure: Diabetes
timeFrame: 3 months
measure: Diabetes
timeFrame: 6 months
measure: Diabetes
timeFrame: 12 months
Secondary outcomes:
measure: Fracture Risk Assessment Tool (FRAx) assessment
timeFrame: 0 and 12 months
Other outcomes:
Locations:
city: El Ejido
country: Spain
facility: Research Site
state: Almeria
city: Huercal Overa
country: Spain
facility: Research Site
state: Almeria
city: Merida
country: Spain
facility: Research Site
state: Badajoz
city: El Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Aranda de Duero
country: Spain
facility: Research Site
state: Burgos
city: Miranda de Ebro
country: Spain
facility: Research Site
state: Burgos
city: Ferrol
country: Spain
facility: Research Site
state: Coru?a
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Illes Balears
city: Logrono
country: Spain
facility: Research Site
state: La Rioja
city: Monforte (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Coslada
country: Spain
facility: Research Site
state: Madrid
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Research Site
state: Madrid
city: Antequera
country: Spain
facility: Research Site
state: Malaga
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Osuna
country: Spain
facility: Research Site
state: Sevilla
city: Reus
country: Spain
facility: Research Site
state: Tarragona
city: Baracaldo
country: Spain
facility: Research Site
state: Vizcaya
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Galdakao
country: Spain
facility: Research Site
state: Vizcaya
city: Calatayud
country: Spain
facility: Research Site
state: Zaragoza
city: Albacete
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: