Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-28 @ 1:22 AM
Study NCT ID:
NCT05700903
Status:
COMPLETED
Last Update Posted:
2025-10-10
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contributions to Hypertension With Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D011944', 'term': 'Receptors, Androgen'}, {'id': 'C053541', 'term': 'bicalutamide'}, {'id': 'D005485', 'term': 'Flutamide'}, {'id': 'C540278', 'term': 'enzalutamide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D011987', 'term': 'Receptors, Steroid'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-18', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Inflammation', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Proteomic analysis of inflammatory cascade proteins will be quantified in plasma samples.'}, {'measure': 'Change in Oxidative stress', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Whole blood reactive oxygen species will be measured in from venous blood samples using electron paramagnetic resonance spectroscopy'}, {'measure': 'Change in Body composition', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Descriptive variable total body fat mass (for screening and to document any changes with the intervention)'}], 'primaryOutcomes': [{'measure': 'Change in Cardiovagal Baroreflex Sensitivity', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'The change in cardiovagal baroreflex sensitivity will be assessed the modified Oxford procedure'}, {'measure': 'Change in blood pressure reactivity to the cold pressor test', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'The change in blood pressure will be assessed from quiet rest to sympathetic activation using the cold pressor test'}, {'measure': 'Change in exercise pressor reflex', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'The change in blood pressure will be assessed from quiet rest to isometric handgrip exercise'}, {'measure': 'Change in ambulatory blood pressure variability', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Ambulatory blood pressure variability will be determined from 24-hour ambulatory blood pressure monitoring.'}, {'measure': 'Change in beat-to-beat blood pressure variability', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Beat-to-beat blood pressure variability will be using finger photoplethysmography measured in the laboratory.'}, {'measure': 'Change in renal vascular resistance', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Renal blood flow will be determined using ultrasound and blood pressure will be determined using finger photoplethysmography. These measures will be used to estimate renal vascular resistance.'}, {'measure': 'Change in Renal dysfunction biomarkers', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Neutrophil gelatinase-associated lipocalin (NGAL), kidney injury molecule (KIM)-1, interleukin (IL)-18, and vanin-1 will be quantified in urine using commercially available assay kits. Concentrations will be normalized to urinary flow rate.'}], 'secondaryOutcomes': [{'measure': 'Change in sympathetic baroreflex sensitivity', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Changes in muscle sympathetic nerve activity in response to changes in blood pressure will be assessed using the modified Oxford procedure'}, {'measure': 'Change in Sympathetic reactivity', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'The change in muscle sympathetic nerve activity will be assessed from quiet rest to sympathetic activation using the cold pressor test.'}, {'measure': 'Change in glomerular filtration rate', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Glomerular filtration rate and renal plasma flow will be calculated by iohexol (Omnipaque 300, GE Healthcare) clearance technique. Plasma and urine iohexol and p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).'}, {'measure': 'Change in renal plasma flow', 'timeFrame': 'Before and after 9 weeks of androgen deprivation therapy or placebo', 'description': 'Renal plasma flow will be calculated by p-aminohippurate (Basic Pharma) clearance techniques. Plasma and urine p-aminohippurate clearance will be measured on a High-Performance Liquid Chromatography (HPLC, Waters, Milford, MA).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgen Deprivation Therapy', 'Prostate Cancer', 'Hypertension', 'Autonomic Dysfunction', 'Renal Disease']}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -age 40+ years;\n* resting blood pressure \\<140/90 mmHg;\n* fasted blood glucose \\<126 mg/dL;\n* testosterone ≥400 ng/dL;\n* sedentary to recreationally active;\n* nonsmokers;\n* healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy;\n* PSA \\<4.00 ng/dL if in the non-cancer group;\n* Gleason Score ≤7 if in the prostate cancer group;\n* no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications);\n* willing and able to be on GnRHagonist and AR inhibitor;\n* not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study;\n* not using exogenous sex hormones for at least one year\n\nExclusion Criteria:\n\n* -acute liver disease;\n* chronic kidney disease, serum creatinine \\>1.3 mg/dL, macroalbuminuria \\>300 mg/g of proteinuria\n* pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;\n* diabetes, active or chronic infection, disease that affects the nervous system;\n* Gleason Score ≥8;\n* thyroid dysfunction, defined as ultrasensitive TSH \\<0.5 or \\>5.0 mU/L, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;\n* tobacco use within the previous 12 months'}, 'identificationModule': {'nctId': 'NCT05700903', 'acronym': 'ARCH', 'briefTitle': 'Contributions to Hypertension With Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Autonomic and Renal Contributions to Hypertension With Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': '22-2201.cc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prostate Cancer', 'description': 'Men undergoing androgen deprivation therapy via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for the treatment of prostate cancer', 'interventionNames': ['Drug: Gonadotropin Releasing Hormone Agonists (GNRH)', 'Drug: Androgen receptor (AR) inhibitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy + ADT', 'description': 'Healthy men undergoing gonadal suppression via gonadotropin releasing hormone agonist plus androgen receptor inhibitor for 9 weeks', 'interventionNames': ['Drug: Gonadotropin Releasing Hormone Agonists (GNRH)', 'Drug: Androgen receptor (AR) inhibitor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy + Placebo', 'description': 'Healthy men undergoing placebo for 9 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gonadotropin Releasing Hormone Agonists (GNRH)', 'type': 'DRUG', 'otherNames': ['Leuprolide', 'Goserelin'], 'description': '8 weeks of GnRH agonist', 'armGroupLabels': ['Healthy + ADT', 'Prostate Cancer']}, {'name': 'Androgen receptor (AR) inhibitor', 'type': 'DRUG', 'otherNames': ['Bicalutamide', 'Flutamide', 'Enzalutamide'], 'description': '2 weeks of AR Inhibitor', 'armGroupLabels': ['Healthy + ADT', 'Prostate Cancer']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet and injection', 'armGroupLabels': ['Healthy + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCHealth University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Matthew Babcock, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}