Clinical trial NCT01020604: PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Obesity
Keywords: BMI
Prostate cancer
Recurrence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-25
Enrollment: 1376
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
timeFrame: Every 3 months
Secondary outcomes:
measure: Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Baja
country: Hungary
facility: Research Site
city: Barcs
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Bekes
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Csongrad
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Dunaharaszti
country: Hungary
facility: Research Site
city: Dunaujvaros
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Helvecia
country: Hungary
facility: Research Site
city: Jaszbereny
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kiskunhalas
country: Hungary
facility: Research Site
city: Koszarhegy
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nagyvenyim
country: Hungary
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
city: Nyirpazony
country: Hungary
facility: Research Site
city: Oroshaza
country: Hungary
facility: Research Site
city: Papa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Salgotarjan
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
city: Szekszard
country: Hungary
facility: Research Site
city: Szentendre
country: Hungary
facility: Research Site
city: Szolnok
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Tiszafoldvar
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
Study officials:
affiliation: Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic
name: Istvan Buzogany
role: PRINCIPAL_INVESTIGATOR
References: