Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-03 @ 12:18 AM
Study NCT ID:
NCT02008058
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of pain palliation responders', 'timeFrame': '6 weeks', 'description': 'Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'Clinical significance of pain score changes', 'timeFrame': '6 weeks', 'description': 'Determine the clinical significance of pain score changes. Pain score changes will be compared with each of the following "anchors": patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). ROC curves derived using logistic regression analyses will be used to characterize the association between change in pain scores and clinically important improvement (defined by anchor variables).'}, {'measure': 'Prevalence and trajectory of pain progression and pain palliation', 'timeFrame': '3 weeks', 'description': 'Descriptive statistics, including Kaplan-Meier, will be used to report findings for the proportion of asymptomatic men who ultimately develop pain, the median time until asymptomatic men develop pain, the median time until men with pain experience pain progression, and the median time until men with pain experience pain palliation.'}, {'measure': 'Quantifying analgesic medication use', 'timeFrame': '26 months', 'description': 'Three different approaches to calculating a single value to represent total analgesic use will be compared: 1) equianalgesic tables published in guidelines of the National Comprehensive Cancer Network (NCCN) which convert various drugs and doses to "morphine equivalents"; 2) point scoring systems used in prior pivotal phase 3 trials based on the World Health Organization analgesic ladder in which lower points are assigned to weaker agents/doses and vice versa for stronger agents/doses; and 3) individual drug dose quantification, a dose recently suggested by the FDA but never empirically evaluated, in which each analgesic is considered individually and a 25% change in dose is considered an increase or decrease for each.'}, {'measure': 'Frequency of pain reporting', 'timeFrame': '7 days', 'description': 'Seven consecutive days of reporting a pain item with a 24-hour recall item will be compared with a single administration of a pain item with a 7-day recall, in order to evaluate if the latter alone is sufficient for measuring pain.'}, {'measure': 'Web-avidity of patients', 'timeFrame': '6 weeks', 'description': "Identify the web-avidity of patients by summarizing patients' responses to questionnaire items about their use of internet and email."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Metastatic Castrate-Resistant Prostate Cancer', 'LCCC 1231', 'Lineberger Comprehensive Cancer Center', 'UNC Lineberger', 'Prostate Cancer', 'Pain'], 'conditions': ['Metastatic Castrate-Resistant Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://unclineberger.org/', 'label': 'Lineberger Comprehensive Cancer Center website'}, {'url': 'http://www.cancer.gov/', 'label': 'National Cancer Institute (NCI) website'}]}, 'descriptionModule': {'briefSummary': 'This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.', 'detailedDescription': 'This is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. The study aims to address several key methodological questions that will inform the design of future clinical trials with symptom endpoints in this population, including: the definition of "clinically meaningful" pain; criteria for concluding a clinically meaningful pain reduction; criteria for concluding clinically meaningful pain progression; reliable methods quantifying analgesic use (given that "equianalgesic tables" and "point scoring systems" are generally considered unreliable by pain researchers and regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different frequencies of symptom reporting; symptom trajectories over time; and associations of pain scores with other metrics used in prostate cancer research (imaging, PSA values, circulating tumor cells, etc).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oncology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must be ≥ 18 years old on the day of consent.\n* The subject is able to understand written and spoken English\n* The patient must have histologically or cytologically confirmed prostate adenocarcinoma.\n* The subject must have castration-resistant prostate cancer (CRPC)\n* The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).\n* The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).\n* The subject must be starting any line treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium 223.\n* The subject owns or has regular access to a telephone (cellular or land line).\n* The subject is willing and able to self-report pain and analgesic use via an automated telephone system.\n* The subject is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.'}, 'identificationModule': {'nctId': 'NCT02008058', 'briefTitle': 'Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'LCCC 1231'}, 'secondaryIdInfos': [{'id': '12-2562', 'type': 'OTHER', 'domain': 'UNC IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Arm', 'description': 'Surveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer', 'interventionNames': ['Behavioral: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'BEHAVIORAL', 'otherNames': ['Webcore telephone survey system'], 'description': 'Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ethan Basch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}