Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-03-03 @ 4:05 AM
Study NCT ID:
NCT01233557
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2010-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Bone Resorption in Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-04', 'studyFirstSubmitDate': '2010-11-02', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Prostate Cancer']}, 'descriptionModule': {'briefSummary': "Biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. Changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. It is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men with hormone sensitive prostate cancer with bone metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate cancer with bone metastases\n* hormone sensitive\n\nExclusion Criteria:\n\n* inadequate renal function\n* ongoing dental problems\n* previous bisphosphonate therapy'}, 'identificationModule': {'nctId': 'NCT01233557', 'briefTitle': 'Biomarkers of Bone Resorption in Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Measurement of Biomarkers of Bone Resorption in Patients With Hormone Sensitive Bone Metastases From Prostate Cancer Treated With Antiandrogen Therapy and Bisphosphonates', 'orgStudyIdInfo': {'id': '10/S0802/36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bone Metastases'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Donald Bissett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Grampian'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}