PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients
PROTECT-Z
1 other identifier
observational
1,376
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 20, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedApril 30, 2013
April 1, 2013
3.3 years
November 20, 2009
April 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.
Every 3 months
Secondary Outcomes (1)
Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire
Every 3 months
Eligibility Criteria
Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer
You may qualify if:
- Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy
You may not qualify if:
- Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Baja, Hungary
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Barcs, Hungary
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Békés, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Csongrád, Hungary
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Debrecen, Hungary
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Dunaharaszti, Hungary
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Dunaújváros, Hungary
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Győr, Hungary
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Gyula, Hungary
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Helvécia, Hungary
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Jászberény, Hungary
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Kaposvár, Hungary
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Kecskemét, Hungary
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Kiskunhalas, Hungary
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Kőszárhegy, Hungary
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Makó, Hungary
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Miskolc, Hungary
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Nagyvenyim, Hungary
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Nyíregyháza, Hungary
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Nyírpazony, Hungary
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Orosháza, Hungary
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Pápa, Hungary
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Pécs, Hungary
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Salgótarján, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Szentendre, Hungary
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Székesfehérvár, Hungary
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Szolnok, Hungary
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Szombathely, Hungary
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Tiszaföldvár, Hungary
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Veszprém, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Istvan Buzogany
Budapest City's Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2009
First Posted
November 25, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
April 30, 2013
Record last verified: 2013-04