PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients (PROTECT-Z)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer
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| 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 | |
| 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 May 16, 2013