[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-resistant-prostate-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-resistant-prostate-carcinoma":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,66,94,115,149,173],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100608382","phase-3-testing-different-dosing-schedules-of-the-anti-cancer-drug-lutetium-177lu-psma-rlt-and-its-effect-on-patients-with-advanced-prostate-cancer-reciprocal-trial-100608382",false,"NCT07200830","Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial","Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma\n* PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET\u002FCT scan (either gallium Ga 68 gozetotide \\[68Ga-PSMA-11\\], fluorine F 18 piflufolastat \\[18F- DCFPyl\\], or fluorine F 18 flotufolastat gallium \\[18F-rhPSMA-7.3\\]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease\n* PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng\u002FmL\n* PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:\n\n  * Serum 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  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions\n  * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 \\[PCWG3\\] criteria, Scher et al 2016)\n* PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n* PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone)\n\n  \\* ARPI must be stopped at least 4 weeks prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration\n* PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)\n* PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible\n* PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed\n* PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 28 days prior to pre-registration is not allowed\n* PRE-REGISTRATION (STEP 0): Age ≥ 18 years\n* PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) or \\\u003C 3 x ULN in patients with Gilbert's syndrome\n* PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation\n* PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction\n* PRE-REGISTRATION (STEP 0): Patients with treated\u002Fstable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n\n  \\* Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)\n* PRE-REGISTRATION (STEP 0): Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* PRE-REGISTRATION (STEP 0): Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* PRE-REGISTRATION (STEP 0): Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration\n* PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy\n* PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs\n* PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration\n* PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression\n* PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish\n* REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT\n* REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +\u002F-3 days\n* REGISTRATION (STEP 1): ECOG Performance Status ≤ 2\n* REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n* REGISTRATION (STEP 1): Platelet count ≥ 100,000\u002Fmm\\^3\n* REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL\u002Fmin\u002F1.73m\\^2 using the Modification of Diet in Renal Disease (MDRD) equation","MALE","18 Years",{"count":19,"type":20},1524,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.",[26,27,28],"Metastatic Castration-Resistant Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-03-31",{"date":37,"type":20},"2034-09-09",{"name":39,"class":40},"Alliance for Clinical Trials in Oncology","OTHER",102,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100534231","phase-1-cell-therapy-steap1-cart-with-enzalutamide-for-the-treatment-of-patients-with-metastatic-castration-resistant-prostate-cancer-100534231","NCT06236139","Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer","Phase 1\u002F2 Dose-Escalation and Cohort Study of STEAP1 CART With Enzalutamide in Participants With mCRPC","Inclusion Criteria:\n\n* Tissue confirmation of prostate adenocarcinoma\n* Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA ( ≥ 1 ng\u002FmL)\n* Must have progressed (at least 2 rising PSA levels with at least a 1-week interval and a minimum PSA of 1.0 ng\u002FmL, progression per RECIST 1.1, or 2 or more new bone lesions by bone scan), after becoming castration-resistant\n* Have received the following for metastatic prostate cancer:\n\n  * At least two lines of treatment\n  * At least two Food and Drug Administration (FDA)-approved therapies with at least one being a second generation androgen receptor signaling inhibitor (e.g., abiraterone, darolutamide, apalutamide, or enzalutamide)\n  * All available targeted therapies for which they are eligible in the metastatic setting (e.g., PARP inhibitors for BRCA 1\u002F2 and immune checkpoint inhibitor for MSI-H or TMB-H ≥ 10 mut\u002FMb)\n* Castrate levels of testosterone (\\\u003C 50 ng\u002FdL) with or without the use of androgen deprivation therapy\n* 18 years or older at the time of enrollment\n* Capable of understanding and providing a written informed consent\n* Fertile male participants and their female partners must be willing to use an effective contraceptive method before, during, and for at least 4 months after the STEAP1 CART cell infusion\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants will be permitted to receive radiation therapy for palliative purposes throughout the study period, except during the 2-week period prior to undergoing leukapheresis\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \\> 50 mL\u002Fmin as calculated using the Cockcroft-Gault formula and not dialysis dependent\n* Total bilirubin ≤ 1.5 x ULN. Participants with suspected Gilbert syndrome may be included if Total bilirubin (Bili) \\> 3 mg\u002FdL but no other evidence of hepatic dysfunction\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x ULN\n* ≤ grade 1 dyspnea and oxygen saturation (SaO2) ≥ 92% on ambient air\n* If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) \\>= 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of \\>= 40% of predicted will be eligible\n* Participants \\>= 60 years of age are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to lymphodepletion chemotherapy. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be \\>= 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* Absolute neutrophil count (ANC) \\> 1500 cells\u002F mm\\^3\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\> 100,000 per mm\\^3\n\nExclusion Criteria:\n\n* Expecting to conceive or father children for the duration of the trial through 4 months after T cell infusion\n* Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)\n* Corticosteroid therapy at a dose equivalent of \\>15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable\n* Concurrent use of other investigational anti-cancer agents except for androgen deprivation therapy\n* Active uncontrolled infection: human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm\\^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication\n* Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit compliance with study requirements\n* Untreated brain metastases: Participants with small asymptomatic brain metastases ( \\\u003C 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of PI, so long as all other eligibility criteria are met\n* Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of \\> 15 mg prednisone (or equivalent) per day, unless otherwise approved by PI\n* Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Peripheral neuropathy related to diabetes or prior chemotherapy is acceptable\n* Other medical, social, or psychiatric factor that interferes with medical appropriateness and\u002For ability to comply with study, as determined by the PI\n* Known allergic reactions to any of the components of study treatments",{"count":50,"type":20},48,[52,53],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety and effectiveness of cell therapy (STEAP1 CART) with enzalutamide in treating patients with prostate cancer that continues to grow despite surgical or medical treatments to block androgen production (castration-resistant) and that has spread from where it first started (the prostate) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer deaths in men. Localized prostate cancer is often curable and even metastatic disease may respond to treatment for a few years. Despite multiple therapies, including hormone therapy and chemotherapy, metastatic castration-resistant prostate cancer (mCRPC) remains an incurable disease. Recently, adoptive cellular immunotherapies have been developed to transfer immunogenic cells to the patient to produce an anti-tumor response. Chimeric antigen receptor T (CART)-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Prostate stem cell antigen and prostate specific membrane antigen CAR T cell therapies have been shown to be safe and effective, but objective tumor responses remain rare. STEAP1 is an antigen that promotes cancer growth and spread and is found to be broadly expressed in mCRPC tissues. STEAP1 CART is CAR T cells that have been engineered with a STEAP1 antigen to better target prostate tumor cells. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving STEAP1 CART with enzalutamide may kill more tumor cells in patients with mCRPC.",[26,27,28],"2026-06-24",{"date":58,"type":33},"2026-06-26",{"date":60,"type":33},"2024-11-26",{"date":62,"type":20},"2027-03-30",{"name":64,"class":40},"Fred Hutchinson Cancer Center",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":65},"100447983","phase-1-abemaciclib-before-177lu-psma-617-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-100447983","NCT05113537","Abemaciclib Before 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","Phase I\u002FII Study of CDK4\u002F6 Inhibition With Abemaciclib to Upregulate PSMA Expression Prior to 177Lu-PSMA-617 Treatment in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Chemotherapy","UPLIFT","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed prostate cancer. Either fresh biopsy or archival tissue can be used for confirmation.\n2. Age \\>= 18 years.\n3. Patients must have metastatic castration resistant prostate cancer (mCRPC) with progression based on Prostate Cancer Working Group 3 (PCWG3) criteria.\n4. Patients must have adenocarcinoma histology.\n5. Prior treatment with at least one novel hormonal agents (NHA) such as abiraterone acetate, enzalutamide, apalutamide, darolutamide etc.\n6. Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL)\n7. Patients must have a 68Ga-PSMA-11 PET scan with at least one PSMA-positive lesions (maximum standardized uptake value \\[SUVmax\\] greater than SUVmax of liver) as determined by nuclear medicine review prior to start of lead-in treatment with abemaciclib\n8. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2\n9. Patients must have life expectancy of \\> 6 months\n10. Patients must have adequate organ function as outlined below and bone marrow reserve\n\n    * White blood cell (WBC) \\> 2.5\n    * Absolute neutrophil count (ANC) \\> 1.5\n    * Hemoglobin (Hgb) \\>= 8.0 \\[Note- Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\\]\n    * Platelets (Plt) \\>= 100 x 10\\^9\u002FLiter (100,000\u002FMicroliter)\n    * Total bilirubin =\\\u003C 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome =\\\u003C 2 ULN and direct bilirubin within normal limits is permitted\n    * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\\\u003C 3 X institutional upper limit of normal (=\\\u003C 5.0 ULN for patients with liver metastases)\n    * Creatinine =\\\u003C 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation.\n11. Patient must be able to swallow oral medications\n12. Patients must have the ability to understand a written informed consent document, and the willingness to sign it\n13. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n14. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n15. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n16. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n17. Patients with reproductive potential must agree to use effective contraception and to not donate sperm during the study and for at least 2 months following the last dose of study treatment. Effective method of contraception means male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, or cervical cap with spermicide\n\nExclusion Criteria:\n\n1. Patients with small cell or neuroendocrine carcinoma histology.\n2. Patients with a super scan seen in the baseline bone scan. Super scan refers to a bone scan with diffusely increased skeletal radioisotope uptake relative to soft tissue\n3. Patients with prior treatment with CDK4\u002F6 inhibitors\n4. Patients with prior treatment with PSMA-targeted radioligand therapy. Patients with previous treatment with PSMA targeting therapies (Such as Chimeric antigen receptor T cells (CAR-T) or Bi-specific T-cell engagers (BiTEs) are eligible.\n5. Patients treated with Radium-223 within 6 weeks prior to study entry.\n6. Any systemic anti-cancer therapy within 3 weeks of study entry\n7. Patients who have experienced significant radiation-related adverse events (AEs) from prior radiation treatment (\\>= grade 3) or have experienced persistent radiation-related AEs that have not resolved by the time of study randomization\n8. Patients with a history of central nervous system (CNS) metastases are ineligible unless they have received prior therapy (surgery, radiation therapy (RT), gamma knife) are asymptomatic, and not receiving corticosteroids for this indication. Head imaging is not required\n9. Patients with symptoms of cord compression or impending cord compression\n10. Patients with concurrent serious medical conditions as determined by primary investigator\n11. Patients with other significant malignancies that are expected to alter life expectancy or interfere with disease assessment. Patients with adequately treated skin cancer, non-muscle-invasive bladder cancer and patients with prior history of malignancy who have been disease free for more than 2 years are eligible. Patients with history of in-situ\u002Fearly stage melanoma will not be excluded\n12. Patients who have not recovered from adverse events due to prior anti-cancer therapy to =\\\u003C grade 1 or baseline (other than alopecia or peripheral neuropathy)\n13. Patients with serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n14. The patient has active systemic bacterial infection (requiring intravenous (IV) antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment\n15. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n16. Patients currently receiving any other investigational therapeutic agents.","ALL",{"count":76,"type":20},30,[52,53],"This phase I\u002FII trial tests the safety, side effects, and best dose of abemaciclib and whether it works before 177Lu-PSMA-617 in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abemaciclib is in a class of medications called kinase inhibitors. It is highly selective inhibitors of cyclin-dependent kinase 4 and 6, which are proteins involved in cell differentiation and growth. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. Radioligand therapy uses a small molecule (in this case 177Lu-PSMA-617), which carries a radioactive component to destroys tumor cells. When 177Lu-PSMA-617 is injected into the body, it attaches to the prostate-specific membrane antigen (PSMA) receptor found on tumor cells. After 177Lu-PSMA-617 attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving abemaciclib before 177Lu-PSMA-617 may help 177Lu-PSMA-617 kill more tumor cells.",[80,27,81,82,28,83,84],"Castration-Resistant Prostate Carcinoma","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Metastatic Castration-resistant Prostate Carcinoma","Metastatic Castration-resistant Prostate Cancer","2026-04-09",{"date":87,"type":33},"2026-04-13",{"date":89,"type":33},"2022-07-08",{"date":91,"type":20},"2027-12-31",{"name":93,"class":40},"Vadim S Koshkin",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":112,"locationsCount":114},"100556530","phase-2-low-psma-suv-boost-lps-boost-intensified-177lu-psma-617-treatment-for-patients-with-metastatic-castrate-resistant-prostate-cancer-with-low-psma-expressing-disease-100556530","NCT06526299","Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease","A Phase 2 Study of Biomarker-Modulated PSMA Theranostics","Inclusion Criteria:\n\n* Patients must have the ability to understand and sign an approved informed consent.\n* Patients must have the ability to understand and comply with all protocol requirements.\n* Patients must be ≥ 18 years of age.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Patients must have a life expectancy \\> 6 months.\n* Patients must have histological, pathological, and\u002For cytological confirmation of prostate cancer.\n* Patients must have a positive 68Ga-PSMA PET\u002FCT scan with no PSMA negative lesion, as determined by the Nuclear Medicine site investigator. The presence of PSMA-positive lesions was defined as 68Ga-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system. PSMA negative disease defined as lymph nodes of 2.5 cm or visceral lesions or soft tissue component of a lytic bone lesion of 1.0 cm or larger with uptake less than that of liver parenchyma.\n* Patients must have whole body tumor SUVmean of \\\u003C 10 on 68Ga-PSMA PET\u002FCT scan, as determined by the Nuclear Medicine site investigator. 68GaPSMA PET\u002FCT will be analyzed using a semi-quantitative approach with MIM software (MIM Software Inc.). The workflow identified whole-body regions of interest (ROIs) with an maximum standardized uptake value (SUVmax) greater than 3 and a lesion size of at least 0.5 mm. The reviewer then manually removes any instances of physiological activity or uptake that are not related to the disease. The method of whole-body quantification will automatically calculate the whole body SUVmean.\n* Patients must have prior orchiectomy and\u002For ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL) at the most recent evaluation before enrollment.\n* Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (such as enzalutamide and\u002For abiraterone).\n* Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:\n\n  * Serum 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  * Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions.\n  * Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Working Group 3 (PCWG3) criteria, Scher et al 2016).\n* Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 45 days prior to beginning study therapy. Measurable disease by per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 is not required, as prostate cancer patients may not have RECIST-measurable disease but have detectable disease on bone scan.\n* Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.).\n* White blood cell (WBC) count ≥ 2.5 x 10\\^9\u002FL (2.5 x 10\\^9\u002FL is equivalent to 2.5 x 10\\^3\u002FuL and 2.5 x K\u002FuL and 2.5 x 10\\^3\u002Fcumm and 2500\u002FuL) OR absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (1.5 x 10\\^9\u002FL is equivalent to 1.5 x 10\\^3\u002FuL and 1.5 x K\u002FuL and 1.5 x 10\\^3\u002Fcumm and 1500\u002FuL).\n* Platelets ≥ 100 x 10\\^9\u002FL (100 x 10\\^9\u002FL is equivalent to 100 x 10\\^3\u002FuL and 100 x K\u002FuL and 100 x 10\\^3\u002Fcumm and 100,000\u002FuL).\n* Hemoglobin ≥ 9 g\u002FdL (9 g\u002FdL is equivalent to 90 g\u002FL and 5.59 mmol\u002FL).\n* Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome ≤ 3 x ULN is permitted.\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases.\n* Albumin \\> 3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL).\n* Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients who have partners of childbearing potential: Partner and\u002For patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 14 weeks after last study drug administration. The patients should not donate sperm throughout the treatment period and for 14 weeks following the last treatment.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to treatment day 1. Previous PSMA-targeted radioligand therapy is not allowed.\n* Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]) within 30 days prior to treatment day 1.\n\n  * Concurrent bone strengthening agents such as bisphosphonates (such as zolendronic acid) and RANKL inhibitors (such as denosumab) are allowed.\n* Any investigational agents within 30 days prior to treatment day 1.\n* Known hypersensitivity to the components of the study therapy or its analogs.\n* Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n* Transfusion within 30 days of treatment day 1.\n* Patients with a history of central nervous system (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.\n* Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.\n* Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.",{"count":102,"type":20},51,[53],"This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.",[26,28],"2026-03-23",{"date":108,"type":33},"2026-03-24",{"date":110,"type":33},"2025-04-29",{"date":91,"type":20},{"name":113,"class":40},"University of Washington",3,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":65},"100570318","phase-1-novel-ack1-inhibitor-r-9b-in-patients-with-prostate-cancer-100570318","NCT06705686","Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer","Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9b in Patients With Prostate Cancer","PHAROS","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed prostate cancer (mCRPC).\n2. Must have evidence of metastatic disease on conventional imaging (eg. CT, MRI, technetium bone scan). May have any type or location of metastases (bone, lymph node, visceral). RECIST 1.1 measurable disease is not required; may have bone-only metastases.\n3. Ongoing androgen deprivation therapy (ADT) at time of study enrollment (GnRHR agonist such as leuprolide, goserelin, triptorelin, buserelin, histrelin; GnRHR antagonists such as degarelix or relugolix), or history of surgical castration.\n4. Must have evidence of castrate testosterone levels with baseline serum testosterone level of 50 ng\u002FdL or less at time of study start, and castrate levels should be maintained throughout study.\n5. Evidence of progressive castration-resistant prostate cancer, defined as at least 2 consecutive rises of PSA, at least 1 week apart with the last PSA ≥ 2 ng\u002FmL or by evidence of radiographic progression.\n6. Patients must have had prior disease progression on at least one novel hormonal agent (NHA) (eg enzalutamide, abiraterone, apalutamide, darolutamide, etc.); treatment with NHA could have occurred in the castration-sensitive or castration-resistant setting.\n7. Prior palliative radiation therapy for bone metastasis (must be complete ≥ 14 days prior to enrollment) or any other radiation therapy (must be complete ≥ 28 days prior to enrollment) is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed.\n8. Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and\u002For stable on supportive therapy.\n9. At least 18 years of age.\n10. ECOG performance status ≤ 1\n11. Normal bone marrow and organ function as defined below:\n\n    * Absolute neutrophil count ≥ 1,500\u002Fmm3 without granulocyte colony-stimulating factor support\n    * White blood cell count ≥ 2,000\u002Fmm3\n    * Platelets ≥ 100,000\u002Fmm3 without transfusion\n    * Hemoglobin ≥ 9.0 g\u002FDL\n    * Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease ≤ 3.0 x IULN)\n    * AST(SGOT), ALT(SGPT) ≤ 3.0 x IULN\n    * Serum creatinine ≤ 1.5 x IULN or calculated creatinine clearance ≥ 45 mL\u002Fmin by Cockcroft-Gault\n    * Serum albumin ≥ 2.8 g\u002FdL\n    * Urine protein\u002Fcreatinine ration (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol) (only evaluated if creatinine abnormal per criteria above\n    * PT\u002FINR or PTT \\\u003C 1.5 x IULN (PT\u002FINR must be drawn \\\u003C 7 days prior to biopsy for those patients treated in MTD cohort), unless participant is receiving anticoagulant therapy and these are within intended therapeutic ranges for anticoagulant.\n12. Corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 500 ms (by ECG).\n13. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of the legally authorized representative, if applicable).\n14. Willingness and ability to undergo biopsy for research component of the trial (for patients treated in MTD cohort)\n15. Heterosexually active male patients (along with their female partners) are required to use two forms of acceptable contraception, including one barrier method, during participation in the study and for 5 months following the last day of study treatment. If a female partner of a male patient becomes pregnant during therapy or within 5 months after the last day of study treatment, the investigator must be notified in order to facilitate outcome follow-up.\n\nExclusion Criteria:\n\n1. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before first dose of study treatment.\n2. Exclusively small cell variant of prostate cancer, or other prostate cancer histology that does not contain adenocarcinoma\n3. Inability to swallow pills.\n4. Presence of a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 calendar days of start of study treatment. Inhaled or topical steroids and adrenal replacement steroid doses \\\u003C 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.\n5. 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, or superficial bladder cancer. Any history of prior malignancy must be reviewed by the PI.\n6. Currently receiving any other investigational agents.\n7. Any anti-androgen receptor agents or abiraterone (or similar CYP17,20 lyase inhibitor) within 14 days or 5 half-lives, whichever is longer, prior to the start of study drug.\n8. Use of Radium-223 or other radioligand\u002Fradiopharmaceutical within 28 days prior to the start of study drug\n9. Any gastrointestinal issues affecting absorption (e.g. gastrectomy, bowel resection, etc), as determined by the PI.\n10. Blood transfusion within 28 days of screening.\n11. Use of hormonal agents or supplements with potential anti-tumor activity against prostate cancer, as determined by the PI, within 28 days prior to the start of study drug.\n12. Bone-modifying agents (eg zolendronic acid, denosumab, etc) may not be initiated after start of study drug; previously initiated agents may be continued while on trial.\n13. Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Eligible subjects must be neurologically asymptomatic.\n14. History of seizures or seizure disorder.\n15. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to (R)-9bMS used in the study.\n16. Uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n    * Cardiovascular disorders:\n\n      * Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n      * Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 160 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n      * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within six months before the first dose of study treatment.\n\n        * Subjects with a diagnosis of incidental, subsegmental PE or DVT within six months are allowed if stable, asymptomatic, and treated with anticoagulation for at least 1 week before the first dose of study treatment.\n    * Gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation, as determined by the PI:\n\n      * The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n      * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within six months before the first dose.\n\n    Note: Complete healing of an intra-abdominal abscess must be confirmed before the first dose.\n    * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before the first dose.\n    * Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n    * Lesions invading or encasing any major blood vessels.\n    * Other clinically significant disorders that would preclude safe study participation.\n\n      * Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n      * Uncompensated\u002Fsymptomatic hypothyroidism.\n      * Moderate to severe hepatic impairment (Child-Pugh B or C).\n17. Active hepatitis B or C or active HIV per review of medical records. Patients with well-controlled HIV or hepatitis B or C, or who have had curative treatment for hepatitis C, may be considered if they meet all other criteria and after discussion with the PI using the following criteria for guidance:\n\n    https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F121319\u002Fdownload\n18. History of organ allograft.\n19. Major surgery (e.g., GI surgery removal or biopsy of brain metastasis) within eight weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred one month before the first dose and from minor surgery (e.g., simple excision, tooth extraction) at least ten days before the first dose (with the exception of the baseline biopsy, which must have occurred no less than 6 days prior to the first dose). Patients with clinically relevant ongoing complications from prior surgery are not eligible.\n20. Any other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise patient safety or adherence with the study requirements (including biopsies), or confound results of the study, over the treatment period.\n21. Any known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies in which they are actively receiving treatment (participation in long-term follow-up is acceptable).",{"count":124,"type":20},40,[52],"TITLE: Phase 1 First in Human Trial to Assess Safety and Tolerability of the Novel ACK1 Inhibitor (R)-9bMS in Patients with Prostate Cancer (PHAROS)\n\nSTUDY DESCRIPTION: Prostate cancer (PC) patients receive androgen deprivation therapy (ADT), but recalcitrant disease recurs typically within 2-3 years, referred to as the Castration Resistant Prostate Cancer (CRPC). Androgen receptor (AR) targeted therapies, such as Enzalutamide (Enz) or Abiraterone (Abi), are FDA-approved therapeutics for CRPC patients. However, virtually all patients develop resistance.\n\nA non-receptor tyrosine kinase, ACK1 act as a novel epigenetic modifier in prostate tumors, regulating AR and its splice variant, AR-V7 expression. A new class of ACK1 small molecule inhibitor, (R)-9bMS, was developed that exhibited excellent drug-like properties. Treatment with (R)-9bMS suppressed Abi and Enz-resistant tumor growth in mice. Robust immune activation against prostate tumors was also reflected in mice treated with ACK1 inhibitor, (R)-9bMS. Importantly (R)-9bMS functionally reinvigorated peripheral blood mononuclear cells (PBMCs) of CRPC patients to mount a robust immune response against CRPC organoids. Collectively, these data indicate that the ACK1 inhibitor, (R)-9bMS, fulfills a unique niche, wherein it not only suppressed AR\u002FAR-V7 within the tumor milieu, but also activated host immune system by overcoming CSK-restrained LCK activity, to mount a robust 'dual' anti-tumor response.\n\nOBJECTIVES: Primary Objective: To assess the safety and tolerability of (R)-9bMS in patients with metastatic castration-resistant prostate cancer.\n\nSecondary Objectives: To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of (R)-9bMS in patients with CRPC. To determine the pharmacokinetics (PK) of (R)-9bMS in patients after single and multiple dose oral administration. To assess clinical outcomes and anti-tumor activity in patients treated with (R)-9bMS.\n\nENDPOINTS: Primary Endpoint: Frequency of dose-limiting toxicities and toxicity and severe AEs per CTCAE v 5.0.\n\nSecondary Endpoints:\n\n* RP2D (recommended phase 2 dose)\n* PK (pharmacokinetics)\n* PSA responses\n* Duration of responses\n* ORR (objective response rate)\n* OS (overall survival)\n* PFS (progression free survival)\n* DSS (disease specific survival)\n* Toxicity and severe AEs per CTCAE v 5.0 STUDY POPULATION: Approximately 18-30 adult patients with a histologic or cytologic diagnosis of metastatic castration resistant prostate cancer will be enrolled.\n\nPHASE: Phase I\n\nDESCRIPTION OF SITES: This study will be open to enrollment at the University of Wisconsin Carbone Cancer Center\n\nDESCRIPTION OF STUDY INERVENTION: (R)-9bMS will be taken by mouth twice daily until completion of 12 cycles, progression or intolerance\n\nSTUDY DURATION: 12 months for enrollment + 12 months treatment + 12 months follow-up + 12 months for data analysis = 48 months.",[128,83],"Metastatic Castration-resistant Prostate Cancer (CRPC)",[130,131,132,133,134,135,136,137,138],"ACK1","TNK2","Non-receptor tyrosine kinase","small molecule inhibitor","prostate cancer","CRPC","kinase inhibitor","Androgen receptor antagonist","Immune modulator","2026-03-17",{"date":141,"type":33},"2026-03-20",{"date":143,"type":33},"2026-03-13",{"date":145,"type":20},"2028-03-30",{"name":147,"class":148},"TechnoGenesys, Inc.","INDUSTRY",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100523699","phase-4-pilot-of-18f-dcfpyl-psma-pet-in-mcrpc-patients-receiving-117lu-vipivotide-tetraxetan-100523699","NCT06099093","Pilot of 18F-DCFPyL-PSMA PET in mCRPC Patients Receiving 117Lu-Vipivotide Tetraxetan","A Pilot Study of 18F-DCFPyL-PSMA PET in Patients Receiving 177Lu-Vipivotide Tetraxetan Therapy for Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed prostate cancer.\n* Age ≥18 years.\n* Participants must be planned for standard-of-care 177Lu-Vipivotide Tetraxetan therapy after the 18F-DCFPyL PSMA-PET.\n\n  -≥1 PSMA-avid lesion on 68Ga-PSMA-11 PSMA-PET performed within 120 days of study entry (to meet eligibility for 177Lu-Vipivotide Tetraxetan therapy).\n* Ability and willingness to comply with the study procedures.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.\n* The effects of 18F-DCFPyL on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after the 18F-DCFPyL PSMA-PET scan.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* Contraindications to PET\u002FCT, including severe claustrophobia.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-DCFPyL\n* Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.",{"count":76,"type":20},[158],"PHASE4","The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET\u002FCT (another type of diagnostic scan for prostate cancer).",[161,84,83],"Prostate Cancer",[161,84,83],"2026-01-28",{"date":165,"type":33},"2026-01-29",{"date":167,"type":33},"2024-04-01",{"date":169,"type":20},"2026-12-01",{"name":171,"class":40},"Brigham and Women's Hospital",2,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":181,"phases":4,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":65},"100600400","spectct-imaging-for-dosimetry-in-177lu-psma-617-pluvicto-therapy-100600400","NCT07096999","SPECT\u002FCT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy","Inclusion Criteria:\n\n* \\* 177Lu-617 PSMA treatment scheduled for mCRPC\n\n  * Clinically stable as determined by the nuclear medicine clinicians\n  * Male\n  * ≥ 18 years of age\n  * Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed",{"count":180,"type":20},60,"OBSERVATIONAL","This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy",[26],[161,185,186,187,188],"177Lu","PSMA","mCRPC","Radioligand Therapy","2025-07-24",{"date":191,"type":33},"2025-07-31",{"date":193,"type":33},"2025-01-23",{"date":195,"type":20},"2031-01-23",{"name":197,"class":40},"University of Michigan Rogel Cancer Center"]