[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"genital-diseases-male\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:genital-diseases-male":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100530754","phase-1-gedatolisib-in-combination-with-darolutamide-in-metastatic-castration-resistant-prostate-cancer-100530754",false,"NCT06190899","Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer","A Phase 1\u002F2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria\n\n1. Adult males ≥18 years of age\n2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \\\u003C10% neuroendocrine type cells\n3. Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)\n4. Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy. Measurable and non-measurable disease are allowed, but metastases visible only on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) will not be allowed for eligibility purposes.\n5. Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following criteria:\n\n   5.1. Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. A minimum PSA of 1.0 ng\u002FmL is required for study entry.\n\n   5.2. Soft-tissue progression defined as an increase ≥20% in the sum of the longest diameter (LD) of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions. 5.3. Progression of bone disease (measurable disease) or 2 or more new bone lesions by bone scan.\n6. Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy\n7. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1\n8. Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)\n9. Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug\n10. At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and\u002For radiation therapy, and resolution of all toxicities related to prior therapies or surgical procedures to baseline (except alopecia, Grade 1 peripheral neuropathy)\n11. Adequate bone marrow, hepatic, renal and coagulation function\n\nExclusion Criteria\n\n1. History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years\n2. Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells\n3. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor\n4. Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).\n5. Subjects with uncontrolled type 1 or type 2 diabetes\n\n9\\. Known and untreated, or active, brain or leptomeningeal metastases. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to randomization 10. History of clinically significant cardiovascular abnormalities 11. Gastrointestinal tract disease resulting in an inability to absorb oral medication as well as history of inflammatory bowel disease 12. Unable to swallow oral medication tablets\u002Fcapsules","MALE","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase 1\u002F2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.",[27,28,29,30,31,32],"mCRPC (Metastatic Castration-resistant Prostate Cancer)","Genital Diseases, Male","Urogenital Diseases, Male","Prostatic Disease","Prostatic Neoplasms, Castration-Resistant","Prostate Cancer",[34,35,36,37,38,32,31,30,29,28],"Gedatolisib","PI3K","Protein Kinase Inhibitors","mCRPC (metastatic castration-resistant prostate cancer)","Darolutamide","RECRUITING","2026-04-07",{"date":42,"type":43},"2026-04-13","ACTUAL",{"date":45,"type":43},"2024-01-01",{"date":47,"type":20},"2030-01",{"name":49,"class":50},"Celcuity Inc","INDUSTRY",13,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":83,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100397880","phase-2-locomotor-training-with-testosterone-to-promote-bone-and-muscle-health-after-spinal-cord-injury-100397880","NCT04460872","Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury","Locomotor Training With Testosterone to Promote Bone and Muscle Health","Inclusion Criteria:\n\n* Men \\>18 years of age\n* Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \\>60-days\n* Low serum total testosterone (\\\u003C300 ng\u002FdL), bioavailable testosterone (\\\u003C110 ng\u002FdL), or free testosterone (\\\u003C46 pg\u002FmL or \\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\\\u003C6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone\n* Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m\u002Fs on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.\n* Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology\n* Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation\n* Willingness to administer TRT as instructed by the study staff and to abide by study protocol\n* Documented approval from the study physician verifying medical status\n\nExclusion Criteria:\n\n* Currently participating in another research protocol that may influence study outcomes.\n* Mental state that precludes understanding the study protocol.\n* Life expectancy \\\u003C12-months.\n* History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures\n* Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury\n* Current prostate, breast, or other organ cancer or a history of prostate or breast cancer\n* Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated\n* Serum prostate-specific antigen (PSA) \\>3.0 ng\u002FmL \\[men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng\u002FmL\\]\n* Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer\n* Currently seeking fertility or expected during the duration of the study\n* Gynecomastia\n* Hematocrit (HCT) \\>49%\n* Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)\n* Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (NYHA class III or IV)\n* Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events\n* History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia\n* LDL cholesterol \\>160 mg\u002FdL with history of any major CV event, defined above, within the last 12-months\n* Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and\u002For a major surgery scheduled at the time of screening\n* Liver enzymes (AST or ALT) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)\n* Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \\\u003C0.70 g\u002Fcm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)\n* Current anticoagulant therapy (contraindication for i.m. injections)\n* Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone\n* Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days\n* Acute use (\\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \\>7.5 mg\u002Fd prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration\n* Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)\n* Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration",{"count":60,"type":20},21,[24],"This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.",[64,65,66,67,68,69,70,71,72,28,73,74,75,76,77,78,79,80,81,82],"Spinal Cord Injury","Spinal Cord Injuries","Trauma, Nervous System","Wounds and Injury","Central Nervous System Diseases","Spinal Cord Diseases","Gonadal Disorders","Endocrine System Diseases","Hypogonadism","Spinal Cord Trauma","Injuries, Spinal Cord","Walking, Difficulty","Gait Disorders, Neurologic","Locomotion Disorder, Neurologic","Wounds and Injuries","Nervous System Diseases","Testosterone Deficiency","Androgen Deficiency","Hormone Deficiency",[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,64],"Testosterone","Testosterone enanthate","Testosterone undecanoate","Testosterone 17 beta-cypionate","Methyltestosterone","Androgens","Hormones","Hormone Substitutes, and Hormone Antagonists","Physiologic Effects of Drugs","Pharmacologic Actions","Therapeutic Uses","Anabolic Agents","Testosterone Replacement Therapy","Dual Energy X ray Absorptiometry","Lean Tissue Mass","Body Composition","Muscle Strength","Muscle Mass","Bone Mineral Density","Adipose Tissue","Body Fat","Density, Bone","Bone Formation","Bone Resorption","Bone Density Conservation Agents","Magnetic Resonance Imaging","Walking","Ambulation","Locomotor","Locomotion","Treadmill","2025-05-01",{"date":117,"type":43},"2025-05-06",{"date":119,"type":43},"2021-01-31",{"date":121,"type":20},"2026-06-30",{"name":123,"class":124},"North Florida Foundation for Research and Education","OTHER",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":147,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":163},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",{"count":134,"type":20},15,[136],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[139,31,140,141,142,29,28,143,144,145,146],"Prostatic Neoplasms","Metastatic Prostate Cancer","Male Urogenital Diseases","Prostatic Diseases","Neoplasms","Neoplasms by Site","Urogenital Neoplasms","Genital Neoplasms, Male",[148,149,150,151,152],"Prostate cancer","PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":155,"type":43},"2024-11-27",{"date":157,"type":20},"2024-12-15",{"date":159,"type":20},"2027-11-01",{"name":161,"class":162},"VA Greater Los Angeles Healthcare System","FED",1]