[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-neoplasm-of-prostate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-neoplasm-of-prostate":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100527642","phase-2-mdrt-in-prostate-cancer-treated-with-long-term-androgen-deprivation-therapy-in-the-stampede-trial-metanova-100527642",false,"NCT06150417","MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant must have an ECOG performance status ≤ 1.\n* Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET\u002FCT. Biopsy of sites of metastasis is strongly encouraged, but not required.\n\n  * There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.\n* Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.\n\n  * Participants may have started LHRH agonist or antagonist therapy, and\u002For androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.\n* In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and\u002For extra-pelvic lymph node (LN) stations.\n\n  * Extra-pelvic LN stations are superior to the regional\u002Fpelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.\n\n    * Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and\u002For heterogeneous morphology\n* In participants who undergo PSMA PET\u002FCT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and\u002For extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation\n\n  * In participants extra-pelvic nodal (M1a) disease only by PSMA PET\u002FCT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:\n\n    * 1\\. PSA ≥ 40\n    * 2\\. Evidence of cN1 disease (pelvic LN)\n    * 3\\. Decipher score ≥ 0.89\n* Adequate organ and marrow function to receive treatment per treating physician\n* Medically fit for treatment and agreeable to follow-up.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nParticipants with the presence of any of the following:\n\n* Castration resistant prostate cancer (CRPC).\n* Evidence of visceral or intracranial metastases.\n* Participant receiving any other investigational agents for cancer.\n* Participant is participating in a concurrent treatment protocol for cancer.\n* Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or SBRT.\n* Prior definitive treatment to the primary prostate cancer or pelvis.\n* Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \\> 10), active pituitary or adrenal dysfunction, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence\n* Active Crohn's disease or ulcerative colitis despite medical management.\n* Refusal to sign informed consent.\n* Any condition that in the opinion of the investigator would preclude participation in this study","MALE","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT).\n\nThe usual treatment for prostate cancer that has spread to other parts of the body is to give lifelong treatment with hormone therapy (also known as androgen deprivation therapy or ADT). Participants may also be given prostate RT even if the disease is metastatic. Participants will receive hormone therapy (the standard treatment for prostate cancer) for 12 months. The hormone therapy agents may be taken by mouth or given as an injection. Participants will also have prostate RT. Up to 50 participants will have surgery to remove the prostate instead of having prostate RT. A portion of the participants will be randomized to receive MDRT to areas where the cancer has spread. For participants who have surgery to remove their prostate, they will be asked to allow tissue samples collected during the surgery to be sent to an outside lab for research tests and extra blood samples drawn for research tests before starting the study, and at the time the cancer becomes worse if applicable. Participation in the study will last approximately 12 months, and will be followed by their doctor for up to five years per standard of care.\n\nThe main goal is to compare the efficacy of the standard of care (standard systemic therapy + definitive prostate-directed local therapy) versus the standard of care with metastasis-directed radiotherapy (MDRT) for consolidation of metastatic disease.",[26,27,28],"Prostate Cancer","Malignant Neoplasm of Prostate","Secondary Malignant Neoplasm of Prostate",[30],"Metastasis-directed Radiotherapy","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2024-07-01",{"date":39,"type":20},"2028-12-01",{"name":41,"class":42},"Case Comprehensive Cancer Center","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100560264","phase-1-stereotactic-body-radiotherapy-and-177lutetium-psma-in-locally-advanced-prostate-cancer-100560264","NCT06574880","STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer","STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I\u002FII Trial","STARLiT","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* ECOG performance status ≤ 1\n* Histologic confirmation of prostate adenocarcinoma of the prostate\n* PSMA avid disease on PSMA PET\u002FCT, where the tumor in the prostate has SUVmax ≥ 10.\n\n  * PSMA PET\u002FCT must be obtained within 4 months.\n* Need ≥ 1 criteria:\n\n  * Node positive disease on PSMA PET\u002FCT or conventional imaging, as defined by having any of the following:\n\n    * Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels\n    * Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.\n  * In the absence of nodal metastasis, must have ≥ 2 of the following\n\n    * i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET\u002FCT\n    * ii. Grade group ≥ 4\n    * iii. PSA ≥ 40 ng\u002FmL\n* Adequate organ and marrow function to receive treatment:\n\n  * Hemoglobin \\> 10 g\u002FdL\n  * White blood cell (WBC) \\> 3000 \u002F mL\n  * Absolute neutrophil count ≥ 1,500 \u002F mcL\n  * Platelets ≥ 100,000 \u002F mcL\n  * Creatinine ≤ 1.5x ULN\n  * Estimated glomerular filtration rate (eGFR)\\* \\> 50 mL\u002Fmin\n  * Total bilirubin\\*\\* \\\u003C 2× ULN\n  * Albumin \\> 3 g\u002FdL\n  * Aspartate aminotransferase (AST) \\\u003C 3× ULN\n\n    * \\*based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL\u002Fmin will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study.\n    * \\*\\* Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted)\n* International Prostate Symptoms Score (IPSS) ≤ 15.\n* Medically fit for treatment and agreeable to follow-up.\n* Ability to understand and the willingness to sign a written informed consent.\n* Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617.\n\nExclusion Criteria:\n\n* Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET\u002FCT is an acceptable substitute to conventional staging.\n* Prostate gland size \\>90 cc measured by CT, ultrasound, or MRI\n* Prior head and neck radiation therapy.\n* Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).\n* Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.\n* Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.\n* History of prior pelvic radiation therapy.\n* Enrollment concurrently in another investigational drug study within 6 months of registration.\n* History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.\n* History of prior myelodysplastic syndrome or acute leukemia.\n* History of or active Crohn's disease or ulcerative colitis.\n* Contraindication to or inability to tolerate PSMA\u002FPET.\n* Any condition that in the opinion of the investigator would preclude participation in this study.\n* Inability to adhere to radiation safety measures in hospital or at home\n* Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other\n* Reduced salivary gland function with baseline CTCAE Gr \\> 1 dry mouth will be excluded.",{"count":52,"type":20},45,[54,23],"PHASE1","The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer.\n\nParticipants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.",[27,57],"Locally Advanced Prostate Cancer",[59],"Prostate cancer","2026-05-21",{"date":62,"type":35},"2026-05-26",{"date":64,"type":35},"2025-05-13",{"date":66,"type":20},"2027-03-01",{"name":68,"class":42},"Angela Y. Jia, MD PhD",1]