Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT01020604
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
2009-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy.', 'timeFrame': 'Every 3 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire', 'timeFrame': 'Every 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BMI', 'Prostate cancer', 'Recurrence'], 'conditions': ['Prostate Cancer', 'Obesity']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult men treated by adjuvant goserelin therapy for at least 1 month after primary (curative) therapy of histologically proven, prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy\n\nExclusion Criteria:\n\n-Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment'}, 'identificationModule': {'nctId': 'NCT01020604', 'acronym': 'PROTECT-Z', 'briefTitle': 'PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NIS-OHU-ZOL-2009/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Baja', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'city': 'Barcs', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 45.96, 'lon': 17.45861}}, {'city': 'Békés', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 21.13333}}, {'city': 'Békéscsaba', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.68333, 'lon': 21.1}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Csongrád', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.71332, 'lon': 20.14241}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Dunaharaszti', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.3545, 'lon': 19.09822}}, {'city': 'Dunaújváros', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.96479, 'lon': 18.93974}}, {'city': 'Győr', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Gyula', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Helvécia', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.83661, 'lon': 19.62251}}, {'city': 'Jászberény', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.5, 'lon': 19.91667}}, {'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Kiskunhalas', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.43402, 'lon': 19.48479}}, {'city': 'Kőszárhegy', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.09251, 'lon': 18.34565}}, {'city': 'Makó', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.21667, 'lon': 20.48333}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Nagyvenyim', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.95764, 'lon': 18.86353}}, {'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Nyírpazony', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.98333, 'lon': 21.8}}, {'city': 'Orosháza', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.56667, 'lon': 20.66667}}, {'city': 'Pápa', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.33004, 'lon': 17.4674}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Salgótarján', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 48.09872, 'lon': 19.80303}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'city': 'Szentendre', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.66943, 'lon': 19.07561}}, {'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'city': 'Szolnok', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Szombathely', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'city': 'Tiszaföldvár', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 46.98333, 'lon': 20.25}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': 'Research Site', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}], 'overallOfficials': [{'name': 'Istvan Buzogany', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Budapest City\'s Local Government "Péterfy Sándor" Hospital and Ambulatory Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}