PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients (PROTECT-Z)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01020604
First received: November 20, 2009
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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


Condition
Prostate Cancer
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Enrollment: 1376
Study Start Date: November 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020604

Locations
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, Hungary
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Istvan Buzogany Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01020604     History of Changes
Other Study ID Numbers: NIS-OHU-ZOL-2009/1
Study First Received: November 20, 2009
Last Updated: April 29, 2013
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
BMI
Prostate cancer
Recurrence

Additional relevant MeSH terms:
Obesity
Prostatic Neoplasms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014