[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostatic-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostatic-diseases":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,89,124],{"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":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100471052","phase-1-anti-tumour-activity-of-177lu-rhpsma-101-injection-100471052",false,"NCT05413850","Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection","An Open-label, Multicentre, Integrated Phase 1 & 2 Study to Evaluate the Safety, Tolerability, Radiation Dosimetry and Anti-tumour Activity of Lutetium (177Lu) rhPSMA-10.1 Injection in Men With Metastatic Castrate-resistant Prostate Cancer","Inclusion Criteria:\n\n1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.\n2. Serum testosterone levels \\\u003C50 ng\u002FdL (1.73 nmol\u002FL) after surgical or continued chemical castration.\n3. Presence of disease target or non target lesions (per RECIST v1.1) on CT\u002FMRI and\u002For presence of disease on full body 99mTc bone scan performed within 28 days of screening.\n4. Positive disease expression of PSMA as confirmed on PSMA PET\u002FCT scan.\n5. At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH).\n6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).\n7. Prior major surgery must be at least 12 weeks prior to study entry.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.\n9. Adequate bone marrow reserve and organ function as demonstrated by blood count, and serum biochemistry at baseline.\n10. Adequate contraception for patients and their partners.\n11. For Phase 1 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide) and at least 1 course (but no more than 2 courses) of taxane-based chemotherapy. For Phase 2 mCRPC only: Subjects who have experienced disease progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide, apalutamide, darolutamide), but have not received previous taxane-based chemotherapy for the treatment of mCRPC.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.\n2. Presence of significant PSMA-negative disease on ceCT\u002FMRI scan\n3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).\n4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.\n5. Known history of haematological malignancy.\n6. Known history of central nervous system (CNS) metastases.\n7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.\n8. Known history of other solid malignancy that may reduce life expectancy and\u002For may interfere with disease assessment.\n9. Unresolved urinary tract obstruction defined as radiographic evidence of hydronephrosis with or without ureteric stent\u002Fnephrostomy.\n10. Any uncontrolled significant medical, psychiatric, or surgical condition or laboratory finding that would pose a risk to subject safety or interfere with study participation or interpretation of individual subject results.\n11. Ongoing treatment with bisphosphonates for bone-targeted therapy.\n12. Severe urinary incontinence that would preclude safe disposal of radioactive urine.\n13. Single kidney or renal transplant or any concomitant nephrotoxic therapy that might put the subject at high risk of renal toxicity during the study in the judgement of the investigator.\n14. Clinically significant abnormalities on a single 12 lead electrocardiogram (ECG) at screening.\n15. Previously received external beam irradiation to a field that includes more than 30% of the bone marrow or kidneys.\n16. Previous treatment with any of the following: PSMA targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium 186, Rhenium-188, Radium-223, hemi-body irradiation.\n17. Subjects with bilateral hip replacements or any significant metallic implants or objects, that may affect image quality and\u002For dosimetry calculations.\n18. Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical study.\n19. Participation in other studies involving IMP(s) within 28 days or 5 half-lives (whichever is longer) prior to study entry and\u002For during study participation.\n20. Any history of clinically significant parenchymal lung disease e.g. interstitial lung disease or bullous emphysema.\n21. Any history of prior thoracic external beam radiotherapy.\n22. Presence of abnormal PSMA PET uptake in the lung parenchyma above expected physiological levels, as determined by local assessment.","MALE","18 Years",{"count":19,"type":20},82,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.",[27,28,29,30,31,32],"Prostate Cancer","Metastatic Castration-resistant Prostate Cancer","mCRPC","Urogenital Neoplasms","Prostatic Neoplasms","Prostatic Diseases",[34,29,35,36,37,38,39,40,41],"PSMA","Prostate cancer","177Lu rhPSMA-10.1","18F-rhPSMA-7.3","BET-PSMA-121","Blue Earth Therapeutics Limited","Radiohybrid","Radiopharmaceuticals","RECRUITING","2026-05-12",{"date":45,"type":46},"2026-05-14","ACTUAL",{"date":48,"type":46},"2022-07-20",{"date":50,"type":20},"2028-03-31",{"name":52,"class":53},"Blue Earth Therapeutics Ltd","INDUSTRY",21,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100483408","imperial-prostate-7---prostate-assessment-using-comparative-interventions---fast-mri-and-image-fusion-for-cancer-100483408","NCT05574647","Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer","Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer","IP7-PACIFIC","Randomisation 1\n\nInclusion Criteria:\n\n* Age 18 years or above (no upper limit)\n* Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).\n* Referred to hospital and advised to undergo a prostate MRI because of an abnormal digital rectal examination (regardless of PSA level) and\u002For an elevated PSA (within 6 months of screening visit) PSA \\>\u002F=3.0ng\u002Fml for age 50-69 years PSA \\>\u002F=5.0ng\u002Fml for age \\>\u002F=70 years If family or ethnic risk for prostate cancer, PSA \\>\u002F=2.5ng\u002Fml for age 45-49 years\n\nExclusion Criteria:\n\n* PSA \\>50ng\u002Fml\n* Prior prostate MRI or prostate biopsy in the two years prior to screening visit\n* Prior diagnosis of prostate cancer\n* Contraindication to MRI or gadolinium contrast\n* Previous hip replacement to both hips\n* Contraindication to performing a biopsy guided by a transrectal ultrasound probe\n\nRandomisation 2\n\nInclusion Criteria:\n\n* Visible suspicious finding on mpMRI or bpMRI from randomisation 1 requiring a targeted biopsy (MRI score 3, 4, 5 on either Likert or PIRADS schema)\n\nExclusion Criteria:\n\n* As above for randomisation 1\n* Patient refusal for biopsy",{"count":64,"type":20},3600,[66],"NA","To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.\n\nTo determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.\n\nTo determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.",[27,69,31,32,70],"Adenocarcinoma","Neoplasms",[27,72,73,74,75,76,77],"Prostate-Specific Antigen","bpMRI","mpMRI","Prostate biopsy","Multi-parametric MRI","Biparametric MRI","2025-07-21",{"date":80,"type":46},"2025-07-24",{"date":82,"type":46},"2022-11-02",{"date":84,"type":20},"2026-01-31",{"name":86,"class":87},"Imperial College London","OTHER",15,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":108,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100570413","phase-4-18f-fluciclovine-petct-impact-on-predicting-clinical-outcome-of-177lu-psma-617-therapy-in-patients-with-prostate-cancer-100570413","NCT06706921","18F-Fluciclovine PET\u002FCT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer","Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET\u002FCT Predicting Clinical Outcome","Inclusion Criteria:\n\n* Patients with mCRPC scheduled to undergo LuPSMA RLT.\n* Willingness to undergo multiple serial PET\u002FCT scans pre- and post-LuPSMA RLT.\n* Ability of providing written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years-old at the time of radiopharmaceutical administration.\n* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.\n* Contraindications to LuPSMA RLT.",{"count":88,"type":20},[98],"PHASE4","This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography\u002Fcomputed tomography 18F-FDG PET\u002FCT and a 18F-DCFPyL PET\u002FCT (18F-DCFPyL (2-(3-{1-carboxy-5-\\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography\u002Fcomputed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography\u002Fcomputed tomography ( Axumin PET\u002FCT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET\u002FCT will be acquired within 7 days from the PSMA PET.\n\nThis study is open to Veterans only.",[31,101,102,103,32,104,105,70,106,30,107],"Prostatic Neoplasms, Castration-Resistant","Metastatic Prostate Cancer","Male Urogenital Diseases","Urogenital Diseases, Male","Genital Diseases, Male","Neoplasms by Site","Genital Neoplasms, Male",[35,109,110,111,112],"PET\u002FCT","Radioligand Therapy","Metastatic Castration-Resistant Prostate Cancer","PSMA PET","2024-11-26",{"date":115,"type":46},"2024-11-27",{"date":117,"type":20},"2024-12-15",{"date":119,"type":20},"2027-11-01",{"name":121,"class":122},"VA Greater Los Angeles Healthcare System","FED",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":133,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":123},"100559460","european-registry-for-transperineal-laser-ablation-of-prostate-tpla-for-lower-urinary-tract-symptoms-100559460","NCT06564415","European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms","European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)","Inclusion Criteria:\n\n* Age ≥18 years;\n* Prostate volume ≥ 30 mL;\n* Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)\n* Consent to participate;\n\nExclusion Criteria:\n\n* Absence of consent;\n* Subsequent withdrawal of consent;\n* Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance\n* Documented bladder impaired contractility\n* Urethral stenosis\n* Previous prostate surgery",{"count":132,"type":20},2500,"5 Years","OBSERVATIONAL","The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and\u002For time until surgical retreatment.\n\nData regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.\n\nSecondary objectives of the study are:\n\n* To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;\n* To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.",[137,32],"Benign Prostatic Hyperplasia",[139,140,141,142,143],"TPLA","Transperineal Laser Ablation","LUTS","BPH","Benign Prostatic Obstruction","2024-08-18",{"date":146,"type":46},"2024-08-21",{"date":148,"type":46},"2024-01-11",{"date":150,"type":20},"2034-01",{"name":152,"class":87},"University of Florence"]