Prostatic Cancer Clinical Trial
— UROCOROfficial title:
Metabolic Changes in Prostate Cancer Patients With Androgen-ablation Therapy (AAT)
| Verified date | December 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics CommitteeSpain: Spanish Agency of Medicines |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 197 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Albacete | |
| Spain | Research Site | Alcala de Henares | Madrid |
| Spain | Research Site | Antequera | Malaga |
| Spain | Research Site | Aranda de Duero | Burgos |
| Spain | Research Site | Baracaldo | Vizcaya |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Bilbao | Vizcaya |
| Spain | Research Site | Calatayud | Zaragoza |
| Spain | Research Site | Cordoba | |
| Spain | Research Site | Coslada | Madrid |
| Spain | Research Site | El Ejido | Almeria |
| Spain | Research Site | El Hospitalet de Llobregat | Barcelona |
| Spain | Research Site | Ferrol | Coru?a |
| Spain | Research Site | Galdakao | Vizcaya |
| Spain | Research Site | Granada | |
| Spain | Research Site | Guadalajara | |
| Spain | Research Site | Huercal Overa | Almeria |
| Spain | Research Site | Jaen | |
| Spain | Research Site | Logrono | La Rioja |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Majadahonda | Madrid |
| Spain | Research Site | Merida | Badajoz |
| Spain | Research Site | Miranda de Ebro | Burgos |
| Spain | Research Site | Monforte (casco Urbano) | Lugo |
| Spain | Research Site | Osuna | Sevilla |
| Spain | Research Site | Palma de Mallorca | Illes Balears |
| Spain | Research Site | Reus | Tarragona |
| Spain | Research Site | Sabadell | Barcelona |
| Spain | Research Site | San Sebastian | Guipuzcoa |
| Spain | Research Site | San Sebastian de Los Reyes | Madrid |
| Spain | Research Site | Toledo | |
| Spain | Research Site | Vigo | Pontevedra |
| Spain | Research Site | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Metabolic syndrome | 3 months | No | |
| Primary | Metabolic syndrome | 6 months | No | |
| Primary | Metabolic syndrome | 12 months | No | |
| Primary | Diabetes | 3 months | No | |
| Primary | Diabetes | 6 months | No | |
| Primary | Diabetes | 12 months | No | |
| Secondary | Fracture Risk Assessment Tool (FRAx) assessment | 0 and 12 months | No |
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