[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054118","phase-2-measuring-circulating-tumor-deoxyribonucleic-acid-tumor-fraction-to-guide-early-177lu-psma-617-treatment-discontinuation-in-patients-with-metastatic-castration-resistant-prostate-cancer-dynamo-trial-100054118",false,"NCT07698535","Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial","Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study","Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Adult males ≥ 18 years age\n* History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes)\n* Evidence of metastatic disease on bone scan or CT scan\n* Patient must have evidence of castration- resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \\[PCWG3\\] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg\u002FdL)\n\n  * Serum\u002Fplasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng\u002FmL\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment and progression on at least one androgen receptor pathway inhibitor (ARPI), in either castration-sensitive or castration-resistant setting\n* Eligible for treatment with either 177Lu-PSMA-617 or docetaxel as per their respective Food and Drug Administration (FDA) labels\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance ≥ 50 ml\u002Fmin (calculated by Cockcroft-Gault formula)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome (direct bilirubin ≤ 1.5 x ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN. For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN\n* Able to comply with study requirements including provision of peripheral blood samples at specified time points for correlative studies\n\nExclusion Criteria:\n\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or provision of informed consent to participate in this study\n* Evidence of metastatic neuroendocrine\u002Fsmall cell prostate cancer (NEPC). Note: baseline biopsy is not required\n* Patients receiving any systemic therapy (aside from a luteinizing hormone-releasing hormone \\[LHRH\\] analogue) or radiotherapy within 2 weeks prior to study treatment\n* Persistent toxicities (CTCAE grade \\> 2) from prior cancer therapy, excluding alopecia and stable neuropathy\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent\n* Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \\\u003C 200\n* Patients with known active hepatitis (i.e. hepatitis B or C). Prior hepatitis C infection is allowed as long as polymerase chain reaction (PCR) is negative\n* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery\n* Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation \\> 500ms, or congenital long QT syndrome\n* Prior systemic chemotherapy with taxane chemotherapy, including in hormone sensitive setting (e.g. docetaxel or cabazitaxel)\n* Brain metastases or active epidural disease (treated epidural disease is permitted)\n\n  * Note: baseline brain imaging is not required\n* Contraindication to prednisone therapy including poorly controlled diabetes mellitus","MALE","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for the disease to grow, spread, or get worse or come back after a period of improvement. ctDNA TF is a type of ctDNA measurement. Research has shown ctDNA TF may be a promising way to predict which patients will respond to 177Lu-PSMA-617 treatment. Measuring ctDNA TF may help doctors identify which patients may benefit from changing treatments sooner, which may be an effective way to guide early 177Lu-PSMA-617 treatment discontinuation in patients with metastatic castration-resistant prostate cancer.",[26,27],"Metastatic Castration-Resistant Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2026-07-06",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":20},"2026-12-01",{"date":36,"type":20},"2029-07-05",{"name":38,"class":39},"University of Washington","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100609789","phase-1-177lu-psma-617-in-combination-with-sipuleucel-t-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-100609789","NCT07219147","177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer","Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Male\n* Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features\n* Patients must have either:\n\n  * Measurable disease\n\n    * For extranodal (visceral) lesions (e.g. lung, liver, etc.) to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT\n    * For lymph nodes to be considered measurable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT\n  * OR non-measurable disease\n\n    * All other lesions, including small lesions (longest diameter \\\u003C 20 mm with conventional techniques or \\\u003C 10 mm with spiral CT scan) and truly non-measurable lesions\n    * Lesions that are considered non-measurable include bone lesions (only). Progression on first generation ADT\n* Patients must have been on androgen deprivation therapy with a gonadotrophin releasing hormone (GnRH) analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at least 3 months prior to study entry and maintain castrate levels of serum testosterone \\\u003C 50 ng\u002FdL throughout study participation unless intolerant\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (within 10 days prior to day 1 of protocol therapy)\n* White blood cell (WBC) counts \\> 2500\u002FuL (within 10 days prior to day 1 of protocol therapy)\n* Lymphocyte count ≥ 300\u002FuL (within 10 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000\u002Fmm\\^3 (within 10 days prior to day 1 of protocol therapy)\n* Hemoglobin ≥ 9g\u002FdL (within 10 days prior to day 1 of protocol therapy)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to day 1 of protocol therapy) (unless has Gilbert's disease, serum bilirubin level ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 10 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (within 10 days prior to day 1 of protocol therapy)\n* Alkaline phosphatase ≤ 3 x ULN (within 10 days prior to day 1 of protocol therapy) (Patients with documented bone metastases, alkaline phosphatase \\[ALP\\] ≤ 5 x ULN)\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL\u002Fmin per Cockcroft-Gault formula (within 10 days prior to day 1 of protocol therapy)\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 10 days prior to day 1 of protocol therapy)\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.3 x ULN (within 10 days prior to day 1 of protocol therapy)\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\]) (within 10 days prior to day 1 of protocol therapy)\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed. OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* For male patients with partners of childbearing potential, agreement (by patient and\u002For partner) to use highly effective form(s) of contraception or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy (e.g., androgen receptor \\[AR\\] antagonists, 5 alpha reductase inhibitor, estrogen), or radiotherapy, within 4 weeks prior to initiation of study treatment\n\n  * Treatment with any of the following medications or interventions within 28 days of registration:\n\n    * External beam radiation therapy or surgery\n    * Chrysanthemum morifolium\u002FGanoderma lucidum\u002FGlycyrrhiza glabra\u002FIsatis indigotica\u002FPanax pseudoginseng\u002FRabdosia rubescens\u002FScutellaria baicalensis\u002FSerona repens supplement (PC-SPES) (or PC-SPEC) or saw palmetto\n    * Systemic corticosteroids. Use of inhaled, intranasal, and topical steroids is acceptable\n    * Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate\n    * Ketoconazole\n    * 5-alpha-reductase inhibitors (e.g., finasteride \\[Proscar®\\], dutasteride \\[Avodart®\\])\n    * High dose calcitriol (1,25\\[OH\\]2 vitamin \\[Vit\\]D) (i.e., \\> 7.0 ug\u002Fweek)\n* Prior treatment with 177\\^Lu-PSMA-617 and\u002For sipuleucel-T\n* Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n* Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration\n* Patients with acute leukemias, accelerated\u002Fblast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma\n* Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases\n* Inability to comply with study and follow-up procedures\n* Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":49,"type":20},30,[51],"PHASE1","This phase I trial compares the effect of lutetium Lu 177 (177\\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and\u002For effective compared to 177\\^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.",[26,27],"RECRUITING","2026-04-16",{"date":57,"type":32},"2026-04-20",{"date":59,"type":32},"2026-03-06",{"date":61,"type":20},"2028-07-26",{"name":63,"class":39},"City of Hope Medical Center"]