[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psma-pet\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psma-pet":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,80,103,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587074","psma-petmri-guided-prostate-biopsy-for-pi-rads-3-and-prior-negative-biopsy-100587074",false,"NCT06923657","PSMA PET\u002FMRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy","Application of PSMA PET\u002FMRI-guided Prostate Targeted Biopsy in Patients With PI-RADS ≤ 3 and Negative Previous Biopsy: A Single-center, Prospective, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Serum PSA \\> 4 ng\u002FmL\n* At least one prior negative prostate biopsy\n* At least two consecutive increases in PSA and\u002For PHI\n* Negative digital rectal examination\n* Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3\n\nExclusion Criteria\n\n* Age ≤ 30 years or \\> 85 years\n* Concurrent presence of other malignant tumors\n* Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)\n* Inability to comply with PSMA PET\u002FMRI examination (e.g., contrast allergy, claustrophobia, etc.)\n* Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)\n* Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)\n* Incomplete clinical or pathological data","MALE","30 Years","85 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal is to provide more accurate diagnostic tools and optimized diagnostic workflows for clinically suspected prostate cancer patients with prior negative biopsies, improving early detection rates for csPCa and reducing missed diagnoses.",[27,28],"Prostate Cancer Screening","PSMA-PET",[30,31,32],"imaging examinations","PSMA PET\u002FMRI","Prostate cancer","RECRUITING","2026-05-26",{"date":36,"type":37},"2026-05-28","ACTUAL",{"date":39,"type":37},"2025-05-07",{"date":41,"type":21},"2026-12-01",{"name":43,"class":44},"First Affiliated Hospital of Fujian Medical University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100635520","plasma-exosomal-rna-signature-for-prostate-cancer-bone-metastasis-100635520","NCT07553754","Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis","Plasma Exosomal RNA Signature for Predicting PSMA PET-Defined Bone Metastasis in Prostate Cancer: A Prospective, Multicenter Discovery, Development, and Validation Study","EXO-MET","Inclusion Criteria\n\n1. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging.\n2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery).\n3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable).\n\n   Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80°C until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination.\n4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection).\n5. Patients who provide written informed consent to participate in the study.\n6. Age ≥18 years.\n\nExclusion Criteria\n\n1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery).\n2. Patients whose blood samples were collected after prostate biopsy.\n3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer).\n4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \\\u003C8 mL).\n5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.","18 Years",{"count":56,"type":21},1000,"OBSERVATIONAL","Brief Summary:\n\nThis prospective, multicenter study aims to discover, develop, and validate a plasma exosomal RNA-based signature as a rule-out test for predicting bone metastasis in prostate cancer, using baseline treatment-naïve PSMA PET as the gold standard. The study is designed in four sequential phases:\n\nPhase 1 (Discovery, n=250): High-throughput sequencing of plasma exosomal RNAs to identify differentially expressed candidate RNAs.\n\nPhase 2 (Model Development, n=300): Digital droplet PCR (ddPCR) analysis of candidates in an independent cohort to construct and lock the final multi-RNA predictive signature using appropriate machine learning methods.\n\nPhase 3 (Internal Validation, n=300): Independent validation of the locked signature in a consecutive cohort reflecting natural disease prevalence.\n\nPhase 4 (External Validation, n=150): Final independent validation in a multi-center cohort enriched for bone metastasis.\n\nPrimary Outcome:\n\nTo evaluate the diagnostic performance of the signature as a rule-out test for PSMA PET-defined bone metastasis. The primary performance metrics are:\n\nSensitivity, with a prespecified target of ≥95% (to ensure minimal false negatives).\n\nSpecificity at the threshold that achieves the ≥95% sensitivity. A specificity of ≥30% will be considered supportive of clinical utility. A specificity of ≥30% (or a lower bound of the 95% confidence interval exceeding 20%) will be considered supportive of clinical utility.\n\nNeed:\n\nCurrent biomarkers lack sensitivity and specificity for early detection of bone metastasis. More importantly, existing tools lack adequate negative predictive value to safely rule out bone metastasis in low-risk patients, leading to over-imaging or delayed detection. There is an urgent need for a non-invasive rule-out test to safely defer PSMA PET\u002FCT in very-low-risk patients. Plasma exosomal RNAs offer a promising liquid biopsy approach, but prospective multicenter studies with rigorous validation are lacking.\n\nSecondary Outcomes:\n\n1. Secondary metrics include negative predictive value (NPV), positive predictive value (PPV), area under the ROC curve (AUC), calibration, and decision curve analysis.\n2. Correlation between exosomal RNA levels and number of bone metastatic lesions (PSMA PET).\n3. Association with PSA, PSMA PET SUVmax, and MRI findings.\n4. Tissue-plasma correlation to confirm tumor origin (exploratory).\n5. Mechanistic exploration of key candidates via in vitro\u002Fin vivo assays (exploratory).\n6. Subgroup analyses by hormone sensitivity, metastatic pattern, Gleason grade (exploratory).\n\nInclusion Criteria:\n\n1. Histologically confirmed prostate cancer scheduled for baseline PSMA PET.\n2. PSMA PET performed prior to any prostate cancer-related treatment.\n3. Blood samples collected prior to any treatment AND prior to prostate biopsy.\n4. Willing to undergo prostate biopsy if clinically indicated (after blood collection).\n5. Written informed consent.\n6. Age ≥18 years.\n\nExclusion Criteria:\n\n1. Any prior prostate cancer treatment before baseline PSMA PET.\n2. Blood samples collected after prostate biopsy.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Inadequate blood sample quality or quantity.\n5. Severe comorbidities interfering with study conduct.",[60,61,62,63,64,65,66],"Prostate Cancer (Diagnosis)","Bone Metastasis","PSMA PET","Liquid Biopsy","Exosomal RNA","Biomarker Discovery and Validation","Treament-naive",[68,61,62,63,64,69],"Prostate Cancer","Predictive Signature","2026-04-20",{"date":72,"type":37},"2026-04-28",{"date":74,"type":37},"2026-03-12",{"date":76,"type":21},"2027-12-31",{"name":78,"class":44},"Xijing Hospital",9,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":79},"100635522","serial-psma-pet-for-therapy-monitoring-in-clinically-significant-prostate-cancer-100635522","NCT07553780","Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer","Serial PSMA PET for Treatment Response Monitoring in Newly Diagnosed Clinically Significant, Treatment-Naïve Prostate Cancer - A Prospective, Multicenter Study","PSMA-TM","Inclusion Criteria\n\n1. Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer).\n2. Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination).\n3. Undergo baseline PSMA PET\u002FCT imaging prior to any prostate cancer-related treatment.\n4. Age ≥18 years.\n5. Willing and able to comply with the follow-up schedule, including the second PSMA PET\u002FCT scan.\n6. Provide written informed consent.\n\nExclusion Criteria\n\n1. Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET\u002FCT.\n2. Contraindications to PSMA PET\u002FCT imaging (e.g., known severe allergic reaction to radiotracer components, inability to lie flat for the duration of the scan).\n3. Other active malignancy within the past two years, excluding non-melanoma skin cancer.\n4. Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient.\n5. Unable or unwilling to provide informed consent.",{"count":89,"type":21},110,"This prospective, multicenter study aims to evaluate the clinical utility of serial PSMA PET for therapy monitoring in patients with newly diagnosed clinically significant prostate cancer.\n\nClinically significant prostate cancer is defined as Gleason score ≥7.Patients will undergo baseline PSMA PET\u002FCT prior to any treatment. A second PSMA PET\u002FCT will be performed either at PSA recurrence (PSA rise ≥2 ng\u002FmL above nadir after radiotherapy or biochemical progression per PCWG3 criteria) or at a fixed time window of 12-24 months after treatment completion for those without biochemical recurrence.\n\nPrimary Outcome:\n\n1\\. Absolute and relative change in SUVmax from baseline to follow-up PSMA PET, correlated with treatment response categories (complete response, partial response, stable disease, progressive disease) defined by a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes).\n\n\\[Time Frame: Baseline and follow-up (up to 24 months)\\]\n\nSecondary Outcomes:\n\n1. Absolute and relative change in the number of PSMA-avid lesions (primary tumor, nodal, bone metastases) as a supportive exploratory endpoint.\n2. Proportion of patients with treatment strategy change following serial PSMA PET.\n3. Agreement between PSMA PET response (≥30% decrease in SUVmax) and PSA50 response (≥50% PSA decline) using Cohen's kappa.\n4. Agreement between PSMA PET response and PSA90 response (≥90% PSA decline).\n5. Prognostic value of baseline and follow-up PSMA PET parameters for progression-free survival (PFS).\n6. Prognostic value of baseline and follow-up PSMA PET parameters for time to castration resistance (ADT-treated patients only).\n7. Subgroup analyses by treatment type (radiotherapy, ADT, chemotherapy), baseline disease burden (oligometastatic vs. polymetastatic), and Gleason grade group (≤7 vs. ≥8).\n8. Inter-reader agreement for PSMA-avid lesion counts. \\[Time Frame: Up to 2 years, except inter-reader agreement at baseline\\]\n\nNeed:\n\nCurrent treatment response evaluation relies on PSA changes and conventional imaging, which lack sensitivity and accuracy for early assessment. PSMA PET has demonstrated superior sensitivity for detecting prostate cancer lesions, but its role in longitudinal therapy monitoring remains undefined, with no specific regulatory approval for this indication. Prospective data on serial PSMA PET to guide treatment decisions in patients with clinically significant prostate cancer (Gleason score ≥7) are urgently needed.\n\nInclusion Criteria:\n\n1. Newly diagnosed, histologically confirmed clinically significant prostate cancer with Gleason score ≥7.\n2. Planned curative-intent or systemic therapy.\n3. Baseline PSMA PET performed prior to any treatment.\n4. Age ≥18 years.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Prior prostate cancer treatment before baseline PSMA PET.\n2. Contraindication to PSMA PET imaging.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Unable to comply with follow-up schedule.",[92,62,93,94],"High-risk Prostate Cancer","Treatment Response","Therapy Monitoring",[68,62,93,94,96],"High-Risk",{"date":72,"type":37},{"date":99,"type":37},"2021-03-07",{"date":101,"type":21},"2028-12-31",{"name":78,"class":44},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":110,"minAge":54,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":79},"100438269","68ga-psma-pet-in-the-renal-cell-carcinoma-100438269","NCT04987086","68Ga-PSMA PET in the Renal Cell Carcinoma","A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma","Inclusion Criteria:\n\n* 2017 AJCC renal cell carcinoma TNM stage III, IV lesions;\n* In contrast-enhanced CT staging, suspicious metastases were found;\n* There were no known peripheral or central venous problems;\n* 68Ga PSMA PET \u002F CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma;\n* Signed the informed consent form of voluntary participation in clinical trials.\n\nExclusion Criteria:\n\n* Age ≤ 18 years old;\n* Can't stand lying flat in PET \u002F CT examination;\n* There are contraindications for 68Ga PSMA ligands;\n* In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test;\n* Renal function is impaired or hemodialysis is in progress.","ALL","90 Years",{"count":113,"type":21},300,[24],"The primary research purpose is to evaluate the diagnostic efficacy of 68Ga-PSMA PET in metastatic lesions of locally advanced and advanced renal cell carcinoma, and to compare with that of enhanced CT. The second purpose is to evaluate whether 68Ga-PSMA PET can change the treatment decision of patients with locally advanced and advanced renal cell carcinoma",[117,118,62],"Renal Cancer","Metastases",[120,62,121],"advnaced renal cancer","metastases","2026-03-08",{"date":124,"type":37},"2026-03-11",{"date":126,"type":37},"2021-06-01",{"date":128,"type":21},"2027-12-01",{"name":78,"class":44},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":138,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":152,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":45},"100596956","phase-3-psma-pet-combined-with-mri-for-the-detection-of-pca-100596956","NCT07052214","PSMA PET Combined With MRI for the Detection of PCa","A Single Arm, Multicenter, Prospective, Open Label, Longitudinal Phase 3 Study of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) Combined With Magnetic Resonance Imaging (MRI) Compared to Standard of Care (SOC) for the Detection of Prostate Cancer (PCa).","BiPASS","Inclusion Criteria:\n\n1. Male, at least 18 years old.\n2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollment, but a clinician indicated intent to proceed with template biopsy due to non-imaging risk factors.\n\nThese are non-imaging risk factors that would lead a patient to be considered for a template biopsy (including but not exclusive to):\n\n1. Persistently elevated or rising PSA i. PSA ≥ 3.0 ng\u002FmL ii. Rising PSA velocity (e.g., \\>0.35-0.75 ng\u002FmL\u002Fyear over 2-3 years) is also considered suspicious, especially in men with PSA\\\u003C10ng\u002FmL.\n2. High PSA density (PSAD) i. PSA density \\> 0.15 ng\u002FmL\u002Fcm³ is considered high-risk for csPCa. ii. Calculated as PSA (ng\u002FmL) divided by prostate volume (from MRI).\n3. Abnormal digital rectal examination (DRE) i. abnormal findings include:\n\n   1. Nodules\n   2. Induration\n   3. Asymmetry\n   4. Fixation of the prostate ii. An abnormal DRE in any PSA range (including \\\u003C3 ng\u002FmL) increases cancer suspicion.\n\nb) Strong family history of prostate cancer: i. First-degree relative (father or brother) with PCa ii. Any relative diagnosed at \\\u003C65 years of age iii. Multiple affected relatives iv. Known hereditary cancer syndromes (e.g., BReast CAncer gene \\[BRCA\\]1\u002F2, Homeobox protein Hox-B13 \\[HOXB13\\] mutations) c) Other high-risk biomarkers i. 4Kscore: ≥ 7.5-10% risk of high-grade PCa ii. PHI (Prostate Health Index): ≥ 35 suggests elevated risk iii. Prostate Cancer Antigen 3 (PCA3) Score: ≥ 35 considered positive and associated with increased risk of PCa.\n\niv. Any other established biomarker with values in the high-risk range d) Clinical presentation i. Symptoms suggestive of locally advanced disease (e.g., urinary obstruction, bone pain) ii. Prior negative MRI with ongoing clinical concern 3. Prostate biopsy naïve participants. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2 per FDA guidelines. 5. Have the capacity to understand the study and be able and willing to comply with all protocol requirements. 6. Provides consent for anatomical template with\u002Fwithout targeted biopsy based on clinical risk, MRI and PSMA PET result. 7. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant.\n\n8\\. Must agree to practice adequate precautions to prevent pregnancy in a female partner and to avoid potential problems associated with radiation exposure to the unborn child (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, (CTFG \\[Clinical Trial Facilitation Group\\], 2020). Details of contraceptive measures to be taken by male participants and their female partners are described in Appendix 4 of the Protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has had prior treatment for PCa or prior diagnosis of csPCa.\n2. Obvious metastatic disease on prior conventional imaging.\n3. Previous diagnosis of cancer of any primary origin (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy).\n4. Active prostate infection, or urinary test results suggestive of an active urinary tract infection, evident on medical history, within 4 weeks of enrollment.\n5. Prior pelvic irradiation\n6. Demonstrate radiographic findings of PI-RADS 5.\n7. Has abnormalities in physical examination and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance; and\u002For is deemed not suitable for participating in this trial in the opinion of the investigator.\n8. Unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the investigator.\n9. Is unable to attain or remain in a supine position while a PET\u002FCT scan is being performed or unable to tolerate a PET\u002FCT scan\n10. Unable or unwilling to undergo clinical prostate biopsy, has known allergies, hypersensitivity, or intolerance to the investigational drug\u002Fcomparator or its excipients.\n11. Have prior use of radionuclides with an interval of less than 10 effective half-lives before the administration of 68Ga-PSMA-11.\n12. Is participating or plans to participate in any experimental drug or device trial during the study period that are considered outside of therapeutic SOC. Studies involving modifications of sequencing or timing of therapeutic regimens\u002Finterventions would be deemed eligible to enroll",true,{"count":140,"type":21},204,[142],"PHASE3","This is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).",[145,68,146,62,147,148,149,150,151],"PCA","Prostatic Neoplasm","Diagnostic Imaging","Elevated PSA","Positron Emission Tomography","Prostate Biopsy","Carcinoma of the Prostate",[153,154,155,156,157,158,159,160],"Molecular Imaging","Biopsy Naive","Magnetic Resonance Imaging","Biopsy","Targeted Biopsy","Radiopharmaceuticals","Cancer Detection","Urologic Oncology","2025-09-03",{"date":163,"type":37},"2025-09-10",{"date":165,"type":37},"2025-08-18",{"date":167,"type":21},"2026-11",{"name":169,"class":170},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY"]