[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castrate-resistant-prostate-cancer-mcrpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castrate-resistant-prostate-cancer-mcrpc":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,76,98,119,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100637431","phase-2-a-study-of-mevrometostat-with-enzalutamide-in-people-with-prostate-cancer-who-have-previously-received-androgen-receptor-pathway-inhibitor-therapy-100637431",false,"NCT07592910","A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy","A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)","MOMENT","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Age 18 years or older\n* Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features\n* Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study\n* Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging\n* ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)\n* Testosterone level less than 50 ng\u002FdL at screening, with ongoing hormone deprivation therapy or prior surgical castration\n* If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks\n* Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions\n* Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function\n* Willing to use acceptable birth control during the study and for 30 days after the last dose\n\nExclusion Criteria:\n\n* History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)\n* Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe\n* History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months\n* Untreated brain metastases, spinal cord compression, or clinically significant epidural disease\n* Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment\n* AIDS-related illness or active hepatitis B or C (well-controlled HIV is allowed)\n* Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune hepatitis, Wilson's disease, hemochromatosis)\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery\n* Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure NYHA Class III\u002FIV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG\n* Prior or current use of PARP inhibitors and\u002For AKT inhibitors\n* Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)\n* Known allergy to any study drug\n* Blood transfusion within 28 days prior to screening blood tests\n* Use of another investigational drug within 4 weeks before starting study treatment\n* Any other condition that, in the opinion of the investigator, would prevent safe participation\n* Current use or anticipated need for strong CYP3A4\u002F5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start","MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.",[27,28],"Metastatic Castrate Resistant Prostate Cancer (mCRPC)","Prostate Cancer (Adenocarcinoma)",[30,31,32,33,15,34,35],"Mevrometostat","EZH2 inhibitor","Enzalutamide","ARPI resistance","mCRPC","Prostate Cancer","NOT_YET_RECRUITING","2026-05-11",{"date":39,"type":40},"2026-05-18","ACTUAL",{"date":42,"type":21},"2026-08",{"date":44,"type":21},"2029-08",{"name":46,"class":47},"Prostate Cancer Clinical Trials Consortium","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100593121","phase-1-investigating-sx-682-in-combination-with-apalutamide-in-metastatic-castration-resistant-prostate-cancer-100593121","NCT07002320","Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer","ASpiRE: A Proof-of-mechanism and Proof-of-concept Clinical Trial Evaluating the Safety, Tolerability, Biological and Anti-tumour Activity of Apalutamide With Dual CXCR1 and CXCR2 Blockade by SX-682 for Men Suffering From Metastatic Castration-resistant Prostate Cancer (mCRPC)","ASpiRE","Inclusion Criteria:\n\n1. Written informed consent and be capable of cooperating with treatment.\n2. Age ≥ 18 years.\n3. Histologically or biochemically confirmed adenocarcinoma of the prostate and with tumour tissue accessible for research analysis for this trial. Patients who have no histological diagnosis must be willing to undergo a biopsy to prove prostate adenocarcinoma.\n4. Patients recruited to phase 1 dose escalation cohorts must have biopsiable disease and consent to mandatory pre- and post-treatment biopsies (baseline and on Cycle 2 Day 1).\n5. Metastatic castration-resistant prostate cancer.\n6. All patients must have documented resistance to 1 prior next generation antiandrogen therapy (NAAT) defined as:\n\n   For phase 1 and phase 2 Cohorts:\n\n   Patients who have progressed after either enzalutamide, Apalutamide or darolutamide (having received a minimum of 12-weeks of enzalutamide, Apalutamide or darolutamide) will enter phase 1 or phase 2 cohorts directly. Patients that have previously received abiraterone but not an AR antagonist should receive a lead-in with Apalutamide on trial and receive the combination on progression through the lead-in.\n7. Documented prostate cancer progression as assessed by the investigator with RECIST v1.1 and PCWG3 criteria (Section 3.5) with at least two of the following criteria:\n\n   1. Progression of soft tissue\u002Fvisceral disease by RECIST v1.1 and\u002For,\n   2. Progression of bone disease by PCWG3 bone scan criteria and\u002For,\n   3. Progression of PSA by PCWG3 PSA criteria.\n8. PSA ≥ 10ng\u002Fml.\n9. Received prior castration by orchiectomy and\u002For ongoing luteinizing hormone releasing hormone agonist treatment.\n10. Ongoing androgen deprivation with serum testosterone \\\u003C 50 ng\u002FdL (\\\u003C 1.7 nM).\n11. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.\n12. Documented willingness to use an effective means of contraception while participating in the study and for 6 months post last treatment dose.\n13. Able to swallow the study drug.\n14. All efforts should be made to discontinue steroid usage but up-to 5mg BD prednisolone (or equivalent) will be allowed.\n15. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes on trial.\n\nHaemoglobin (Hb) ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1.5 x 109\u002FL Platelet count ≥ 100 x 109\u002FL WBC ≥ 3.0 x 109\u002FL Calculated creatinine clearance ≥ 50 mL\u002Fmin (uncorrected value) Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless documented Gilbert's disease., in which case ≤ 3 x ULN is permissible Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to known metastatic liver disease in which case ≤ 5 x ULN is permissible\n\nExclusion Criteria:\n\n1. Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry\u002Frandomisation into the study (with the exception of abiraterone, enzalutamide, Apalutamide or darolutamide). Any other therapy for prostate cancer, other than gonadotropin releasing hormone analogue therapy, such as progesterone, medroxyprogesterone, progestins or 5-alpha reductase inhibitors, must be discontinued at least 2 weeks before the first dose of the study drug.\n2. Participation in another interventional clinical trial of an IMP within 4 weeks prior to trial entry. Participation in trials of licensed medications is allowed provided the medication is not a prohibited concomitant medication.\n3. Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry.\n4. Clinical and\u002For biochemical evidence of hyperaldosteronism or hypopituitarism.\n5. History of seizures or other predisposing factors including, but not limited to, underlying brain injury, stroke, primary brain tumours, brain metastases and leptomeningeal disease, or alcoholism.\n6. Malabsorption syndrome or other condition that would interfere with enteral absorption.\n7. Any of the following cardiac criteria:\n\n   * QTcF interval \\> 470 msec.\n   * Clinically important abnormalities including rhythm, conduction, or electrocardiogram (ECG) changes (left bundle branch block, third degree heart block).\n   * Factors predisposing to QT prolongation including heart failure, hypokalaemia, congenital long QT syndrome, family history of prolonged QT syndrome, unexplained sudden death (under 40) and concomitant medications known to prolong QT interval.\n   * Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina, congestive heart failure (NYHA ≥ grade 2) i or transient ischaemic attack) in the last 6 months (see appendix 4 for NYHA scale).\n   * Uncontrolled hypotension (systolic blood pressure \\\u003C 90mmHg).\n   * Uncontrolled hypertension on optimal medical management.\n8. Clinically significant history of liver disease (Child-Pugh B or C, viral or other hepatitis, current alcohol abuse or cirrhosis).\n9. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect interpretation of the results or renders the patients at high risk from treatment complications, e.g., patients with a hypersensitivity to the active substance or any of the excipients.\n10. Malignancy other than prostate cancer within 5 years of trial entry except for adequately treated basal cell carcinoma.\n11. Unresolved significant toxicity from prior therapy (except alopecia and grade 1 peripheral neuropathy).\n12. Inability to comply with study and follow-up procedures.\n13. Predominantly small cell or neuroendocrine differentiated (\\> 20% of cells) prostate cancer.\n14. Immunocompromised patients.\n15. Active or uncontrolled autoimmune disease requiring corticosteroid therapy.\n16. History of thromboembolic disease within 12 months of commencement of trial.\n17. At high-risk because of non-malignant systemic disease including active infection and any serious concurrent illness.\n18. Any known intolerance to Apalutamide, SX-682, or to any constituents.\n19. Symptoms of COVID-19 and\u002For documented COVID-19 infection.\n20. Is taking any of the following prohibited medications:\n\n    * Aminophylline\u002Ftheophylline\n    * Atypical antipsychotics (eg, clozapine, olanzapine, risperidone, ziprasidone)\n    * Buproprion\n    * Lithium\n    * Meperidine and pethidine\n    * Phenothiazine antipsychotics (eg, chlorpromazine, mesoridazine, thioridazine)\n    * Tricyclic and tetracyclic antidepressants (eg, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine\n    * Warfarin or coumarin-like anticoagulants\n21. History of previous non-infectious pneumonitis requiring steroid treatment, or active non-infectious pneumonitis.\n22. History of previous severe drug induced severe cutaneous reaction including but not limited to Steven-Johnson's syndrome\u002Ftoxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS).",{"count":57,"type":21},78,[59,24],"PHASE1","ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).",[62],"Metastatic Castrate-Resistant Prostate Cancer (mCRPC)",[64],"Prostate cancer","RECRUITING","2026-04-14",{"date":68,"type":40},"2026-04-15",{"date":70,"type":40},"2025-04-28",{"date":72,"type":21},"2029-10",{"name":74,"class":47},"Institute of Cancer Research, United Kingdom",4,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100519629","phase-1-tmpsma-02-in-mcrpc-100519629","NCT06046040","TmPSMA-02 in mCRPC","Phase I, Open-Label Study of Dually Armored Chimeric Antigen Receptor (CAR) T Cells (TmPSMA-02) in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Signed, written informed consent\n2. Adult participants ≥ 18 years of age\n3. Metastatic castrate-resistant prostate cancer (mCRPC)\n4. Castrate levels of testosterone (\\\u003C50 ng\u002FdL) with\u002Fwithout the use of androgen-deprivation therapy\n5. Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).\n6. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:\n\n   1. Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 50 cc\u002Fmin per the Cockcroft-Gault Equation; Patient must not be on dialysis\n   2. ALT\u002FAST ≤ 3 x ULN\n   3. Serum total bilirubin ≤ 1.5 mg\u002FdL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg\u002FdL)\n   4. Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO\n   5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \\> 92% on room air\n7. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Absolute neutrophil count ≥ 1000\u002FμL\n   3. Platelet count ≥ 75,000\u002FμL\n8. ECOG Performance Status that is either 0 or 1.\n9. Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study.\n10. Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol.\n\nExclusion Criteria:\n\n1. Active hepatitis B or hepatitis C infection\n2. Any other active, uncontrolled infection\n3. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n4. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.\n5. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \\[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\\].\n6. Patients requiring chronic treatment systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg\u002Fday or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications, please see Section 5.6.\n7. Prior treatment with autologous T-cell therapy, with the exception of Sipuleucel-T.\n8. Prior allogeneic stem cell transplant.\n9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.\n10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).",{"count":84,"type":21},30,[59],"This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.",[62],"2025-12-19",{"date":90,"type":40},"2025-12-22",{"date":92,"type":40},"2024-01-31",{"date":94,"type":21},"2042-01-31",{"name":96,"class":47},"University of Pennsylvania",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":97},"100588599","phase-1-personalized-vs-fixed-activity-177lu-psma-617-radiopharmaceutical-therapy-prodigy-2-100588599","NCT06943495","Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)","PROstate-specific Membrane Antigen DosImetry- Guided endoradiotherapY: A Randomized- Controlled, Single-blind, Pilot Study of Personalized vs. Fixed-activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)","PRODIGY-2","Inclusion Criteria:\n\n1. Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;\n2. Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy;\n3. Progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with serum testosterone level ≤ 1.7 nmol\u002FdL);\n4. PSA ≥2 ng\u002FmL ;\n5. Prior treatment with at least one ARPI;\n6. PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization;\n7. ECOG Performance status 0 to 2;\n8. Calculated eGFR (by CKD-EPI formula) ≥ 45 mL\u002Fmin\u002F1.73m\\^2;\n9. Albumin ≥ 25 g\u002FL;\n10. Platelets ≥ 100x10\\^9\u002FL;\n11. Neutrophils ≥ 1.5x10\\^9\u002FL;\n12. Hemoglobin ≥ 90 g\u002FL without transfusion in the past 4 weeks;\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. PSMA-PET \"superscan\" (i.e. extensive\u002Fdiffuse PSMA-positive bone involvement);\n2. Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;\n3. Prior treatment with more than two lines of chemotherapy for mHSPC and\u002For mCRPC (adjuvant and neoadjuvant chemotherapy does not count) towards the maximum of two regimens);\n4. Prior radiopharmaceutical therapy;\n5. Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;\n6. Active malignancy other than prostate cancer;\n7. Patients who are sexually active and not willing\u002Fable to use medically acceptable forms of barrier contraception;\n8. Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;\n9. Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.",{"count":20,"type":21},[59],"The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in a population of patients with metastatic castrate-resistant prostate cancer (mCRPC). The main questions it aims to answer are:\n\n1. Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?\n2. What is the incidence of some specific adverse reactions during the treatment?\n\nResearchers will compare participants receiving a personalized regime to participants receiving the standard fixed-activity regime of 177Lu-PSMA-617 to see if the activity can be safely increased through personalization based on renal dosimetry (i.e. the measure of how much radiation is actually delivered to the kidney).\n\nParticipants will receive up to 6 treatments of 177Lu-PSMA-617 every 6 weeks and be regularly evaluated with imaging and laboratory tests, as well as with questionnaires.",[27],"2025-09-02",{"date":112,"type":40},"2025-09-09",{"date":114,"type":40},"2025-08-15",{"date":116,"type":21},"2033-03",{"name":118,"class":47},"Jean-Mathieu Beauregard",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":97},"100599890","phase-1-phase-ib-trial-of-177lu-psma-it-therapy-in-combination-with-olaparib-and-pembrolizumab-in-patients-with-metastatic-castration-resistant-prostate-cancer-100599890","NCT07090369","Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer","LumOnate","Inclusion Criteria:\n\n1. Patient must have provided written informed consent using the LumOnate Patient Information and Consent Form (PICF)\n2. Patient must be ≥ 18 years of age at Screening\n3. Willing and able to comply with treatment schedule, laboratory testing, and other requirements of the study\n4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n6. At least 2 weeks since the completion of prior therapy, including surgery or radiotherapy\n7. PSA \\> 5 ng\u002FmL\n8. Significant PSMA avidity on PSMA PET\u002FCT, defined as a minimum uptake of SUVmax 15 at a site of disease, and SUVmax \\> 10 at other sites of disease ≥ 10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact)\n9. Radiographic evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2)\n10. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:\n\n    * Haemoglobin ≥ 100 g\u002FL independent of transfusions (no red blood cell transfusion in last 8 weeks)\n    * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n    * Platelets ≥ 150 x 109\u002FL\n    * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases\n    * Albumin ≥ 30 g\u002FL\n    * Adequate renal function: Patients must have creatinine clearance (CrCl) estimated of ≥ 51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test\n11. Patients must have progressed on an ARPI (e.g. enzalutamide, abiraterone, darolutamide\u002For apalutamide). Determination of disease progression on an ARPI will be made by the local Investigator\n12. Patients must have progressive disease defined as any one of the following:\n\n    1. PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 5 ng\u002FmL\n    2. Soft tissue or visceral disease progression as per modified RECIST 1.1 criteria (Appendix 2)\n    3. Bone progression: ≥ 2 new lesions on bone scan (Appendix 2)\n13. Prior surgical orchiectomy or chemical castration maintained on ongoing luteinizing hormone-releasing hormone analogue (agonist or\n14. Patients must have a life expectancy ≥ 24 weeks\n15. Non-sterilised male patients who are sexually active with a female partner of childbearing potential must use a condom from screening to approximately 3 months after the last dose of treatment. Female partners of male patients should also use a highly effective form of contraception throughout this period\n16. Patients who are deemed to have disease that is safe and amenable to biopsy based on screening PSMA PET scans will be mandated to consent to paired tumour biopsies at Screening and on treatment\n\nExclusion Criteria:\n\n1. Prior chemotherapy for mCRPC. Prior docetaxel is permitted if given in the setting of hormone sensitive disease\n2. Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax \\\u003C 10\n3. Extensive marrow disease defined by a \"Super Scan\" on bone scintigraphy or diffuse marrow infiltration on PSMA PET\n4. Active brain metastases or leptomeningeal metastases\n5. Any prior exposure to anti-PD-1, anti-PD-L1\u002FL2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway\n6. Any prior exposure to PARP inhibitors, platinum, or radionuclide therapy\n7. Patients with a history or clinical features suggestive of myelodysplastic syndrome\u002Facute myeloid leukaemia or previously known clonal haemopoiesis\n8. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan or psychiatric illness\u002Fsocial situations that is likely to impede participation and \u002For compliance in the study\n10. Patients with active, known, or suspected autoimmune disease Note: Patients with vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol\n11. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration Note: Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone are permitted in the absence of active autoimmune disease\n12. Malignancy within the previous 2 years other than basal cell or squamous cell carcinomas, skin or melanoma in situ, or other cancers that are unlikely to recur within 24 months\n13. Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C ribonucleic acid (HCV PCR) indicating acute or chronic infection\n14. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable\n15. Persistent toxicities (CTCAE ≥ Grade 2) caused by previous cancer therapy, excluding alopecia\n16. Previous history of interstitial lung disease or non-infectious pneumonitis\n17. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the Investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\> 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome\n18. Known hypersensitivity to olaparib or pembrolizumab or any of the excipients of olaparib or pembrolizumab\n19. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) 1\u002F2. Only need to check this if there is a clinical history. HIV-infected (HIV1\u002F2 antibody-positive) patients may participate if they meet all the following eligibility requirements:\n\n    * They must be on an anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on this same regimen; the most recent undetectable viral load must be within 12 weeks prior to registration\n    * They must have a CD4 count ≥ 250 cells\u002FµL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FµL over the past 2 years unless it was deemed related to the cancer and\u002For chemotherapyinduced bone marrow suppression\n    * For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FµL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy\n    * They must have an undetectable viral load and a CD4 count ≥ 250 cells\u002FµL within 7 days prior to registration\n    * They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within 6 months prior to registration\n20. Concomitant use of known strong cytochrome P450, family 3 (CYP3A) inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks\n21. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and enzalutamide, and 3 weeks for other agents\n22. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation\n23. Participation in another clinical study with an investigational product or another systemic therapy administered within 3 weeks prior to registration",{"count":127,"type":21},20,[59],"This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).",[27],[132,133,134,135,136,137],"prostate cancer","olaparib","pembrolizumab","177Lu-PSMA","metastatic castrate resistant prostate cancer","triplet therapy","2025-07-24",{"date":140,"type":40},"2025-07-29",{"date":142,"type":21},"2025-11-01",{"date":144,"type":21},"2028-12-01",{"name":146,"class":47},"Peter MacCallum Cancer Centre, Australia",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":157,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":97},"100571459","kidney-function-and-risk-factors-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-undergoing-177lutetium-psma-radioligand-therapy-a-prospective-observational-study---kiri-trial-100571459","NCT06720532","Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial","177Lu-PSMA-KiRi-trial","KiRi","Inclusion Criteria:\n\n* Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).\n\nExclusion Criteria:\n\n* Missing or incomplete informed consent.\n* age below 18 years",{"count":156,"type":21},100,"5 Years","OBSERVATIONAL","The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:\n\nWhat is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?\n\nPatients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.",[161,162,27],"Kidney Disease","Radiation Nephropathy",[34,164,135,165],"177Lutetium","radioligand therapy","2024-12-02",{"date":168,"type":40},"2024-12-06",{"date":170,"type":40},"2024-08-05",{"date":172,"type":21},"2031-08-01",{"name":174,"class":47},"Hannah Schaefer","Metastatic Castrate-Resistant Prostate Cancer (mCRPC),"]