Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT05820932
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Cognitive Decline From Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood specimens will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with cognitive decline (ADT cohort)', 'timeFrame': 'Up to 12 months', 'description': 'Proportion with cognitive decline, defined as a decrease in \\>=1 neurocognitive test after ADT by \\>=1 standard deviation (SD) compared to baseline.'}, {'measure': 'Mean cognitive decline (ADT cohort)', 'timeFrame': 'Up to 12 months', 'description': 'The Z-scores of each cognitive test after receiving ADT will be calculated as a repeated measure.'}, {'measure': 'Proportion of participants with cognitive impairment after ADT (ADT Cohort)', 'timeFrame': 'Up to 12 months', 'description': 'Proportion of participants with cognitive impairment after receiving ADT, defined as a score of \\>=1 SD below normative mean score (i.e., PC control) in \\>=1 of the neurocognitive tests given during the course of ADT therapy.'}], 'secondaryOutcomes': [{'measure': 'Change in mean plasma Aβ42/40 ratio', 'timeFrame': 'Up to 12 months', 'description': 'Change in mean plasma Aβ42/40 ratio for the ADT cohort at 12 months will be compared to that of the PC control cohort'}, {'measure': 'Mean cognition score', 'timeFrame': 'Up to 12 months', 'description': 'The Z-scores of each cognitive test will be calculated as a repeated measure.'}, {'measure': 'Mean study partner-reported cognition score', 'timeFrame': 'Up to 12 months', 'description': 'The Z-scores of each cognitive test will be calculated as a repeated measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive decline', 'Cognitive functioning'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "Androgen Deprivation Therapy (ADT) is associated with cognitive impairment and dementia in men with prostate cancer. Pre-clinical data suggest that ADT-induced hypogonadism leads to accumulation of beta-amyloid plaques in the hippocampus, a pathological hallmark of Alzheimer's Disease (AD). Neuroimaging Functional magnetic resonance imaging (fMRI) studies also demonstrate that ADT decreases metabolic activity in the parietal, occipital, and prefrontal cortices. Multiple prospective cohort and population-based clinical studies have been conducted to test the association between ADT and cognitive impairment and/or dementia.\n\nPlasma biomarkers have been developed to predict brain amyloidosis, a key pathological feature of AD and a risk factor for developing dementia due to AD. The advantage of a blood-based assay is the lower cost, invasiveness, and time compared to cerebrospinal fluid (CSF) and Positron Emission Tomography (PET)-based biomarkers.", 'detailedDescription': 'This is a single-site, non-randomized prospective observational study of men with prostate cancer.\n\nPRIMARY OBJECTIVE:\n\nI. To evaluate whether baseline plasma Amyloid-beta 42/40 (Aβ42/40) ratio is associated with cognitive decline in men upon starting ADT.\n\nSECONDARY OBJECTIVE:\n\nI. To evaluate whether ADT is associated with a decline in plasma Aβ42/40 ratio.\n\nII. To evaluate whether intensified ADT (iADT) receipt is associated with greater cognitive decline compared to ADT.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with prostate cancer and partners of participants. The analysis population will consist of participants who complete baseline plasma Aβ42/40 and apolipoprotein E4 (APOE4) collection and the cognitive assessments at baseline and at least 3 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient Participants-\n\n* Age 18 years or greater.\n* Fluent in reading, listening to, and writing English.\n* Current or prior diagnosis of prostate adenocarcinoma based on a pathology report or as documented in a medical oncology, urology, or radiation oncology note.\n* Access and ability to use a computer or mobile device with Internet connectivity to complete study procedures.\n* Telephone Montreal Cognitive Assessment (T-MoCA) of 16 or greater.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (documented within past 3 months, otherwise patient-reported).\n\nStudy partner participants-\n\n* Age 18 years or greater\n* Fluent in reading, listening to, and writing English\n* Identified by patient participant as a person who knows patient participant well, like a friend, family member or spouse.\n* Access and ability to use a computer or mobile device with internet connectivity to complete study procedures.\n\nOnly the ADT cohort-\n\n* Anticipated to start ADT, which includes one of the following two treatments\n\n * Gonadotropin-releasing hormone (GnRH) agonist (e.g., leuprolide, goserelin, and others).\n * GnRH antagonist (i.e., degarelix or relugolix).\n* Anticipated to remain on ADT for at least 12 months.\n* Concurrent first-generation anti-androgens (e.g., bicalutamide, flutamide, nilutamide) and novel androgen-signaling inhibitors (e.g., abiraterone, enzalutamide, and apalutamide) are allowed.\n* Concurrent radiation is allowed.\n\nOnly the PC cohort-\n\n* Has completed definitive local therapy (radical prostatectomy or radiation therapy) for localized prostate cancer at least 6 months prior to screening.\n* For radical prostatectomy: undetectable prostate-specific antigen (PSA) within 12 months of screening.\n* For radiation therapy: last PSA of \\< 2.0 within 12 months of screening.\n\nExclusion Criteria:\n\nPatient Participants-\n\n* Small cell prostate carcinoma (pure or mixed).\n* Receipt of ADT (GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor) within 6 months before screening. ADT \\>6 months prior to screening is allowed provided testosterone has recovered to 100 ng/ml or greater.\n* Concurrent or anticipated (at any point during first 12 months of ADT) non-hormonal, antineoplastic systemic therapy, such as chemotherapy.\n* Testosterone \\<100 ng/ml.\n* Prior or concurrent brain metastases (no prior or screening imaging is required).\n* Major neurocognitive or psychiatric disorders, such as dementia or schizophrenia.\n* Prior or concurrent malignancy other than prostate cancer whose natural history or treatment has the potential to interfere with study assessments.\n\nStudy partner participants-\n\n* None.\n\nOnly the ADT cohort-\n\n* None.\n\nOnly the PC cohort-\n\n* Any prior, concurrent, or anticipated use of any hormonal systemic therapy, including GnRH agonist, GnRH antagonist, 1st-generation anti-androgen, or novel androgen signaling inhibitor.\n* Any known or prior history of M1 prostate cancer (no screening imaging required).\n* Current or prior biochemical recurrence following American Urological Association guidelines for radical prostatectomy or American Society for Therapeutic Radiology and Oncology (ASTRO) guidelines for radiation therapy.'}, 'identificationModule': {'nctId': 'NCT05820932', 'acronym': 'ABC', 'briefTitle': 'Predicting Cognitive Decline From Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Plasma Amyloid-beta 42/40 to Predict Cognitive Decline From Androgen Deprivation Therapy in Prostate Cancer: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '22806'}, 'secondaryIdInfos': [{'id': 'NCI-2023-02192', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with prostate cancer, ADT (ADT Cohort)', 'description': 'This group is comprised of adult men with hormone-sensitive prostate cancer who are starting androgen deprivation therapy as part of standard of care prostate cancer (not as part of this protocol).', 'interventionNames': ['Genetic: Blood-based assay', 'Diagnostic Test: Cognitive assessments', 'Other: Quality of Life Surveys']}, {'label': 'Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))', 'description': 'This group is comprised of adult men who are in remission from prostate cancer who have never received ADT.', 'interventionNames': ['Genetic: Blood-based assay', 'Diagnostic Test: Cognitive assessments', 'Other: Quality of Life Surveys']}, {'label': 'Partners of Participants', 'description': 'Study partner participants will also be recruited', 'interventionNames': ['Other: Quality of Life Surveys']}], 'interventions': [{'name': 'Blood-based assay', 'type': 'GENETIC', 'description': 'Blood samples will be collected', 'armGroupLabels': ['Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))', 'Participants with prostate cancer, ADT (ADT Cohort)']}, {'name': 'Cognitive assessments', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cognitive assessments will be both participant- and partner-reported', 'armGroupLabels': ['Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))', 'Participants with prostate cancer, ADT (ADT Cohort)']}, {'name': 'Quality of Life Surveys', 'type': 'OTHER', 'otherNames': ['QoL Surveys'], 'description': 'Participant-reported Quality of Life Surveys', 'armGroupLabels': ['Participants in remission, No ADT (Prostate cancer Control (PC) Cohort))', 'Participants with prostate cancer, ADT (ADT Cohort)', 'Partners of Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'UCSF Genitourinary Medical Oncology Recruitment', 'role': 'CONTACT', 'email': 'GUTrials@ucsf.edu', 'phone': '877-827-3222'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu'}, {'name': 'Daniel Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'UCSF Genitourinary Medical Oncology Recruitment', 'role': 'CONTACT', 'email': 'GUTrials@ucsf.edu', 'phone': '877-827-3222'}], 'overallOfficials': [{'name': 'Daniel Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}