PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients

Obesity Clinical Trial

— PROTECT-Z  

Official title:

PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients Assessment of the Correlation Between Body Mass Index and Recurrence Among Zoladex Treated Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020604
• Other study ID #: NIS-OHU-ZOL-2009/1
• Status: Completed
• Phase: N/A
• First received: November 20, 2009
• Last updated: April 29, 2013
• Start date: November 2009
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1376
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy

Exclusion Criteria:

-Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Hungary	Research Site	Baja
Hungary	Research Site	Barcs
Hungary	Research Site	Bekes
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Csongrad
Hungary	Research Site	Debrecen
Hungary	Research Site	Dunaharaszti
Hungary	Research Site	Dunaujvaros
Hungary	Research Site	Gyor
Hungary	Research Site	Gyula
Hungary	Research Site	Helvecia
Hungary	Research Site	Jaszbereny
Hungary	Research Site	Kaposvar
Hungary	Research Site	Kecskemet
Hungary	Research Site	Kiskunhalas
Hungary	Research Site	Koszarhegy
Hungary	Research Site	Mako
Hungary	Research Site	Miskolc
Hungary	Research Site	Nagyvenyim
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Nyirpazony
Hungary	Research Site	Oroshaza
Hungary	Research Site	Papa
Hungary	Research Site	Pecs
Hungary	Research Site	Salgotarjan
Hungary	Research Site	Szeged
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szekszard
Hungary	Research Site	Szentendre
Hungary	Research Site	Szolnok
Hungary	Research Site	Szombathely
Hungary	Research Site	Tiszafoldvar
Hungary	Research Site	Veszprem

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.		Every 3 months	No
Secondary	Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire		Every 3 months	No