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

April 29, 2013 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Time Frame: Every 3 months
Every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Istvan Buzogany, Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OHU-ZOL-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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