[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto Oncologico Veneto IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":346},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,74,98,139,160,182,211,240,266,293,324],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607208","intraoperative-ultrasound-guided-vs-wire-guided-vs-magnetic-seed-guided-breast-conserving-surgery-for-non-palpable-tumors-100607208",false,"NCT07185568","IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors","IntraOperative UltraSound Guided Versus Wire Guided Versus Magnetic Seed Guided Breast-conserving Surgery for Non-palpable Tumors.The MANOLA Study Multi-center, Randomized, Open-label Clinical Trial","MANOLA","Inclusion Criteria:\n\n* Patients with non-palpable breast cancer candidate for breast-conserving surgery;\n* Female patients;\n* Patients aged ≥ 18 years;\n* Patients with histologic diagnosis of cT1-T2 invasive BC or ductal carcinoma in situ;\n* Patients amenable for BCS after neoadjuvant chemotherapy;\n* Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Patients with locally advanced disease or metastatic disease;\n* Patients with palpable breast carcinoma;\n* Patients candidate for mastectomy;\n* Patients who are unable to give informed consent\n* Patients candidate for mastectomy.","FEMALE","18 Years",{"count":20,"type":21},1302,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ratio to one of the pre-surgery lesion localization: IOUS HydroMark™ (experimental arm A), magnetic Sirius Pintuition Seed® (experimental arm B) and the wire localization technique (control arm). The randomization will be stratified by lesion type (solid non-palpable (type B); non-solid non-palpable (e.g., microcalcification clusters, architectural distortive areas) (type C); post-NACT residual lesions (type D), and clinical center.",[27,28],"Breast Cancer","Breast-Conserving Surgery",[30,31,32],"IntraOperative UltraSound guided","Wire guided","Magnetic Seed guided","NOT_YET_RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":21},"2026-08-04",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Istituto Oncologico Veneto IRCCS","OTHER",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":72,"locationsCount":73},"100639117","negative-hormone-receptor-and-apocrine-lobular-invasive-breast-cancer-100639117","NCT07613151","Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer","NAPOLI Study: Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer - A Retrospective Multicenter Observational Study","NAPOLI","Inclusion Criteria:\n\n* Female or male patients aged ≥18 years.\n* Histologically confirmed invasive lobular carcinoma of the breast.\n* Presence of apocrine differentiation\u002Ffeatures documented in pathology report or confirmed by local pathology review.\n* Negative hormone receptors.\n* Diagnosis and\u002For treatment at one of the participating centers.\n* Availability of essential clinicopathological data.\n* Availability of follow-up data, when applicable.\n\nExclusion Criteria:\n\n* Pure ductal carcinoma without lobular invasive component.\n* Metastatic tumor to the breast from non-breast primary cancer.\n* Insufficient pathological documentation to confirm eligibility.\n* Missing essential clinical data.\n* Patients who denied consent for retrospective data use, where applicable by local regulations.","ALL",{"count":56,"type":21},250,"OBSERVATIONAL","The NAPOLI Study is a retrospective multicenter observational study designed to characterize negative hormone receptor and apocrine lobular invasive breast cancer. The study will collect real-world clinicopathological, molecular, therapeutic and outcome data from patients diagnosed and treated at participating centers. The aim is to describe the clinical behavior, pathological features, receptor profile, treatments received and oncologic outcomes of this rare breast cancer subtype.",[60],"Lobular Breast Carcinoma",[62,63,64],"Breast","Cancer","Lobular Neoplasia","RECRUITING","2026-05-23",{"date":68,"type":37},"2026-05-29",{"date":70,"type":37},"2026-05-01",{"date":41,"type":21},{"name":43,"class":44},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100537291","phase-2-regorafenib-for-recurrent-meningioma-mirage-trial-100537291","NCT06275919","Regorafenib for Recurrent Meningioma (MIRAGE Trial)","Regorafenib for Recurrent Meningioma. A Multicenter, Randomized Phase II Study (MIRAGE Trial)","MIRAGE","Inclusion Criteria:\n\n* Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted\n* Patients capable of taking oral medication\n* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Histological diagnosis of meningioma according to the WHO 2021 classification\n* Radiologically documented progression of any existing tumor with an estimated planar growth \\>25% (bidirectional) in the last 12 months or appearance of new lesions\n* Ineligible for further surgery and\u002For radiotherapy\n* at least 1 Measurable lesion (minimum 10 x 10mm) on baseline MRI\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 (or KPS ³70)\n* Male or female ≥ 18 years of age\n* Subjects must have life expectancy of at least 6 months\n* Paraffin-embedded tumor tissue available (mandatory)\n* Dosage of dexamethasone or equivalent steroid within 7 days prior the randomization ≤4mg\u002Fdie\n* Stable or decreasing dosage of steroids for 7 days prior to the randomization.\n* Adequate cardiac function and adequate liver, renal and hematological function\n* Subject must have the following laboratory values at screening within 14 days before starting Regorafenib:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL without growth factor support for 7 days (14 days if subject received pegfilgrastim).\n* Hemoglobin (Hgb) ≥10 g\u002FdL\n* Platelet count (plt) ≥100x 109\u002FL\n* Serum potassium concentration within normal range, or correctable with supplements\n* Serum glutamic oxaloacetic transaminase (SGOT)\u002Faspartate aminotransferase (AST) and serum glutamate pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) ≤ 3.0 x Upper Limit of Normal (ULN).\n* Serum total bilirubin ≤ 1.5 x ULN\n* Serum creatinine ≤ 1.5 x ULN or measured glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m2 using an exogenous filtration marker such as iohexol, inulin, 51Cr EDTA or 1125 iothalamate, or creatinine clearance of ≥ 50 mL\u002Fmin using Cockroft-Gault equation.\n* Serum albumin \\> 3.5 g\u002FdL\n* PT (or INR) and APTT within normal range\n* For women who are not postmenopausal (i.e., \\\u003C 2 years after last menstruation) or surgically sterile (absence of ovaries and\u002For uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive device, or barrier method of contraception in conjunction with spermicidal jelly) during the Treatment period and for at least 6 months after the last dose of study drug.\n* For male patients who are partners of premenopausal women: agreement to use a barrier method of contraception during the Treatment period and for at least 6 months after the last dose of study drug.\n* Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to participate.\n* 19\\. Patients with measurable, progressive meningioma who received radiation therapy are potentially eligible but need to show evidence of progression at least 24 weeks from completion of radiation therapy.\n* 20\\. Possible prior use of bevacizumab in the treatment of radionecrosis (3-24 months after radiosurgery or radiotherapy; 5mg\u002Fkg q14w, 4-6 cycles)\n\nExclusion Criteria:\n\n* Prior antineoplastic therapy for meningioma\n* Subject incapacitated to understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted\n* Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)\n* Are taking strong UGT1A9 inhibitors (e.g. mefenamic acid, diflunisal and niflumic acid)\n* Receiving additional, concurrent, active therapy for Meningioma outside of the trial.\n* Disease outside the brain (ie. spinal cord or bone or metastasis to a distant organ)\n* Candidate for urgent palliative intervention for primary disease (e.g., impending herniation) as judged by the Investigator\n* History of allergy or hypersensitivity to any of the study treatments or any of their excipients.\n* In the presence of therapeutic intent to anticoagulate the patient:,INR or PT and aPTT not within therapeutic limits (according to the medical standard in the institution)\n* Unable or unwilling to undergo brain MRI scans with intravenous (IV) gadolinium\n* History of another malignancy in the previous 3 years, with a disease-free interval of\\\u003C 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n* Serious, non-healing wound, ulcer, bone fracture, or abscess.\n* Any cerebrovascular accident (including transient ischemic attacks) within the last 6 months prior to initiation of study treatment.\n* Have an ongoing infection with severity of Grade 2 or above (CTCAE 5.0)\n* Any hemorrhage or bleeding event that is ≥ Grade 3 based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE), Grade 2 intracranial hemorrhage, or persistent thrombotic\u002Fembolic event within 4 weeks prior to the start of study medication.\n* Uncontrolled or severe cardiac disease (e.g., history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the last 6 months prior to initiation of study treatment), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia (including atrial flutter\u002Ffibrillation), requirement for inotropic support or use of devices for cardiac conditions (e.g.,pacemakers\u002Fdefibrillators), or hypertension (participants with systolic blood pressure\\[BP\\] of \\> 160 mmHg or diastolic BP of \\> 100 mmHg despite optimal medical management are to be excluded).\n* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.\n* Active, known, or suspected auto-immune disease, including systemic lupus erythematosus, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa, or auto-immune hepatitis.\n* Known history of hepatitis B, human immunodeficiency virus (HIV), or active hepatitis C infection requiring treatment with antiviral therapy. Note: HIV testing is not required in the absence of clinical suspicion.\n* History of bleeding diathesis (irrespective of severity).\n* Uncontrolled intercurrent illness including (e.g., symptomatic ascites), but not limited to ongoing or active infection.\n* Persistent ≥ Grade 3 Lipase (\\> 2.0 - 5.0 x upper limit of normal \\[ULN\\] with signs or symptoms; \\> 5.0 x ULN and asymptomatic).\n* Persistent proteinuria \\> 3.5 g\u002F24 hours measured by urine protein creatinine ratio from a random urine sample (≥ Grade 3, CTCAE 5.0)\n* Have any malabsorbition condition\n* Any condition that could make the subject noncompliant with the study procedures and\u002For study requirements, as judged by the Investigator (for example: cognitive impairment, psychiatric illness, etc).",{"count":83,"type":21},104,[85],"PHASE2","The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent meningiomas.\n\nSmall trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.\n\nRegorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1\u002F2\u002F3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF\u002FRAF1 and BRAF highly expressed in meningiomas.\n\nNoteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\\\u003C0.05) for Regorafenib treated mice.\n\nMoreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life.",[88],"Meningioma, Malignant","2026-05-12",{"date":91,"type":37},"2026-05-13",{"date":93,"type":37},"2024-09-23",{"date":95,"type":21},"2027-03",{"name":43,"class":44},17,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":123,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":73},"100573965","electrochemotherapy-ect-in-patients-with-primary-visceral-tumors-andor-secondary-visceral-localizations-of-any-histotype-100573965","NCT06753136","Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype","Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and\u002For Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation","Inclusion Criteria:\n\n* Male\u002FFemale ≥ 18 years\n* Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent\n* Diagnosis of primary and\u002For secondary visceral localizations of any histotype\n* Patients who are not eligible for standard curative procedures\n\nExclusion Criteria:\n\n* Absolute contraindications to invasive procedures\n* Concomitant presence of brain, lung, bone metastases\n* Uncorrectable coagulation changes\n* Bleomycin allergy\n* Absolute contraindications to taking Bleomycin\n* Poor respiratory function or pulmonary fibrosis\n* Acute lung infections\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study","99 Years",{"count":107,"type":21},24,[24],"This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes.\n\nAlthough still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745\u002F2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.",[111,112,113,114,115,116,117,118,119,120,121,122],"Primary Visceral Tumors of Any Histotype","Visceral Lesions","Liver Cancer","Liver Metastasis Colon Cancer","Melanoma","Primary Pancreatic Tumor","Retroperitoneal Sarcoma","Abdominal and\u002For Peritoneal Localizations","Merkel Cell Carcinoma","Squamous Cell Carcinoma","Secondary Visceral Localizations of Any Histotype","Non-melanoma Skin Cancer",[124,125,126,127,128,129,130],"electrochemotherapy","visceral lesions","Laparoscopic procedure","Laparotomic procedure","Percutaneous procedure","bleomycin","medical device","2026-04-09",{"date":133,"type":37},"2026-04-13",{"date":135,"type":37},"2025-07-23",{"date":137,"type":21},"2030-02-28",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":73},"100585735","scarless-advanced-breast-extended-oncoplasty-the-scarabeo-study-100585735","NCT06906237","Scarless Advanced Breast Extended Oncoplasty: The ScarABEO Study","ScarABEO","Inclusion Criteria:\n\n* Patients treated with BCS combined with CWPFs for primary stage I-III invasive cancer (IC) or ductal carcinoma in situ (DCIS);\n* Patients treated during the last 10 years (2015-2025);\n* Patients aged 18 years or more;\n* Cases with at least one-year follow-up.\n\nExclusion Criteria:\n\n* Male Patients;\n* Patients aged less than 18 years;\n* Patients who underwent traditional breast conserving surgery or OBCS with displacement techniques;\n* Patients who underwent mastectomy;\n* Patients who underwent implant-based reconstruction;\n* Patients with unresectable breast cancer or metastatic disease;\n* Patients who were lost during follow-up.",{"count":56,"type":21},"Breast conserving surgery followed by radiotherapy is the gold standard treatment for early breast cancer. Cases with unfavorable tumor volume to breast volume ratio or challenging localizations are at higher risk of margin infiltration or poor aesthetic outcomes. While margin infiltration represents one of the strongest predictors of local recurrence, unappealing cosmetic results may significantly impair survivors' quality of life. Over the past two decades, the adoption of oncoplastic breast conserving surgery (OBCS) techniques has shown promise in improving both oncological and aesthetic outcomes after breast cancer surgery. Partial breast volume reconstruction (PBR) after OBCS is obtained through volume displacement (which involves remodelling and redistributing glandular tissue) and volume replacement (when the volume used to reconstruct the defect comes from an extramammary site) techniques.\n\nOne of the greatest examples of volume replacement techniques in breast surgery involves the use of chest wall perforator flaps (CWPF). The use of these well-vascularized dermo-adipose flaps offers oncologically safe wide resection while obtaining excellent cosmetic outcomes. It is particularly suitable for patients with non-ptotic small to medium-sized breasts and cases with an unfavorable tumor volume to breast volume ratio. CWPFs can decrease mastectomy rates in breast cancer surgery, thus avoiding the disadvantages associated with implant-based reconstruction. Consequently, the need of contralateral simmetrization is also diminished.\n\nCWPFs are vascularized by perforator arteries that arise from the chest wall (mainly branches of the axillary artery, or intercostal arteries deriving from the internal mammary artery). While cadaver labs and radiologic studies demonstrated a reliable and coherent localization of perforator arteries, the use of Doppler Ultrasound is often required to localize the perforators and test their reliability. Compared to the traditional myocutaneous flaps (such as the latissimus dorsi flap), CWPFs spare the underlying muscles minimizing donor site morbidity and enabling rapid post-operative recovery, low post-operative complication rates, post-operative pain, and loss of function. All these advantages may result in high levels of patients' satisfaction. Additionally, CWPFs avoid the microsurgical anastomoses required for free flaps.\n\nAll breast quadrants defects could be restored with CWPFs, with the Thoraco-Dorsal Artery Perforator (TDAP), Lateral-Thoracic Artery Perforators (LTAP) and Lateral Intercostal Artery Perforator (LICAP) Flaps particularly suitable for reconstructing lateral quadrant; the Anterior Intercostal Artery Perforator (AICAP) Flap for the lower quadrants and the Internal Mammary Artery Perforator (IMAP) Flaps for volume defects at inner quadrants.\n\nAlthough existing literature reports promising results, the use of CWPFs remains emerging, and OBCS with CWPFs is currently limited to select high-volume breast centers. The collection of robust clinical data is essential to validate these potential advantages and facilitate the broader adoption of this technique.\n\nThis multicentric retrospective observational study aims to collect evidence about the surgical and oncological outcomes of OBCS with CWPFs, to evaluate the potential benefits associated with the use of this innovative technique.",[27,149,150,151],"Oncoplastic Breast Surgery","Oncoplastic Breast-conserving Surgery","Chest Wall Perforator Flap","2026-03-26",{"date":154,"type":37},"2026-03-27",{"date":156,"type":37},"2024-04-18",{"date":158,"type":21},"2026-12-01",{"name":43,"class":44},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100534959","a-study-to-evaluate-efficacy-and-safety-of-hydeal-cyst-intravesical-instillations-in-patients-treated-with-intravesical-chemotherapy-or-immunotherapy-in-non-muscle-invasive-bladder-cancer-100534959","NCT06245603","A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer","Hydeal Cyst","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* ECOG PS 0-2\n* Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.\n* Patients candidate to BCG or MMC intravesical induction therapy.\n* Transurethral resection (TURB\u002Fre-TURB when indicated) performed in the last 12 weeks.\n* IPSS score ≤19\n* Negative urine culture within 2 weeks before T0\n* For women who are not postmenopausal (i.e., \\\u003C 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and\u002For uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period\n* Signed the study informed consent prior to any study specific procedures.\n* Will and ability to comply with the protocol\n\nExclusion Criteria:\n\n* Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue \\> 150 ml;\n* Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it.\n* Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study\n* Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.\n* Urinary tract infection requiring antibiotics\n* Have a known hypersensitivity to any substance present in the investigational device.\n* Neurogenic bladder\n* Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.",{"count":168,"type":21},200,[24],"Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria.\n\nPrior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.\n\nThe following activities and\u002For assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.\n\nBCG or MMC will be started within 1-2 weeks from randomization (within 12-14 weeks after TURB).\n\nBCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.\n\nIPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6\u002F8 (6 for BCG and 8 for MMC) of treatment.\n\n48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.\n\nBCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.\n\nAfter 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.\n\nAfter 6 and 18 weeks from instillation therapy end, a control visit will be made.\n\nA physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.\n\nControl cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.",[172],"Non-muscle Invasive Bladder Cancer","2026-02-04",{"date":175,"type":37},"2026-02-06",{"date":177,"type":37},"2024-12-20",{"date":179,"type":21},"2027-06",{"name":43,"class":44},9,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":105,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":201,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":73},"100618951","virtual-reality-induced-pain-and-anxiety-relief-in-outpatient-urological-procedures-100618951","NCT07338292","VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures","VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA","Inclusion Criteria:\n\n* Male\u002Ffemale with age ≥ 18 years\n* Patient who are undergoing one of the interventions mentioned in the study for the first time;\n* Eligibility for minimally invasive ambulatory urological procedures, possibly requiring vascular access (circumcision, prostate biopsy, flexible cystoscopy);\n* Ability to understand instructions and complete study questionnaires;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Absolute contraindications to the planned urological procedure (e.g., active urinary tract infection, anatomical urethral abnormalities);\n* Recent urological manipulations (e.g., urethral dilation, bladder biopsy, insertion or removal of a double-J stent);\n* Medical contraindications to the use of virtual reality, including uncontrolled photosensitive epilepsy and relevant neurological, ophthalmologic, or otolaryngologic disorders;\n* Presence of severe psychiatric disorders or major cardiovascular diseases that may interfere with study participation;\n* Previous adverse reactions to virtual reality exposure;\n* Use of analgesic medications within 24 hours prior to the procedure;\n* Use of drugs that may alter consciousness or impair the ability to complete psychological assessments;\n* Severe communication disabilities or significant hearing impairment that would prevent completion of questionnaires.",{"count":190,"type":21},56,[24],"Though the efficacy of VRH is documented in various outpatient urological procedures and has provided promising preliminary information in prostate biopsy, its systematic use in urology remains poorly studied. Considering the potential of invasive urological procedures to induce significant patient discomfort, the application of innovative immersive approaches, such as those offered by medical devices, could lead to an overall clinical benefit. Among these, REALICA® (available from https:\u002F\u002FREALICA.io\u002Fen\u002F), a class I CE medical device, widely used in hospitals and validated by numerous studies, represents a valuable resource in urology, supported by high satisfaction rates received in abdominal surgery and extracorporeal lithotripsy",[194,195,196,197,198,199,200],"Urologic Diseases","Prostate Biopsy","Flexible Cystoscopy","Circumcision","Stress","Anxiety","Pain",[202,130],"virtual reality","2026-01-07",{"date":205,"type":37},"2026-01-13",{"date":207,"type":37},"2025-12-17",{"date":209,"type":21},"2026-10-31",{"name":43,"class":44},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":105,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100590238","silibinin-in-association-with-concomitant-chemoradiotherapy-and-maintenance-temozolomide-in-stat3-positive-idh-wild-type-newly-diagnosed-glioblastoma-patients-100590238","NCT06964815","Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients","Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients: a Multicenter, Double-blind, Placebo-controlled, Randomized Study","STRONG","Inclusion Criteria:\n\n* New histologically confirmed diagnosis of glioblastoma (WHO 2021)\n* Local availability of MGMT methylation status\n* Immunohistochemical positivity of activated STAT3 (pSTAT3) expression on the tumor tissue sample. STAT3 expression will be evaluated centrally by UOC Anatomia Patologica of Azienda Ospedale Università di Padova.\n* Chemoradiotherapy start within 7 weeks from surgery\n* Patients without disease progression after surgery\n* Availability of paraffin-embedded tumor tissue\n* Age ≥18 years\n* ECOG PS 0-2; Karnofsky 100-70\n* Signing of informed consent prior to any study procedure\n* Patients (both males and females) should employ adequate contraceptive measures, which should be maintained during the whole duration of the trial (from screening to 6 months after the last dose of Temozolomide).\n* Have adequate bone marrow, liver and kidney function, as measured by the following laboratory assessments conducted within 10 days before the start of study treatment:\n* Hemoglobin \\> 9.0 g\u002Fdl\n* Absolute neutrophil count (ANC) ≥1500\u002Fmm3 without granulocyte colony-stimulating factor (G-CSF) and other hematopoietic growth factors\n* Platelet count ≥100,000\u002Fμl\n* WBC ≥3.0 x 10 9 \u002FL\n* Total bilirubin \\\u003C1.5 times the upper limit of normal\n* ALT and AST \\\u003C3 x the upper limit of normal\n* Serum creatinine \\\u003C1.5 times the upper limit of normal\n* Glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73 m2 according to the abbreviated formula Modified Diet in Renal Disease\n* Alkaline phosphatase \\\u003C2.5 x ULN\n* PT-INR\u002FPTT \\\u003C1.5 x upper limit of normal (patients who are therapeutically anticoagulated with anticoagulant drugs will be able to participate provided there is no history of abnormal background in these parameters, based on history).\n* Complete urinalysis\n* Stable and decreasing corticosteroid dosage in the last 10 days before brain MRI\n\nExclusion Criteria:\n\n* Patients diagnosed with glioblastoma (WHO grade IV 2021) who have only had a diagnostic biopsy\n* Chemotherapy, immunotherapy, or antineoplastic therapy for glioblastoma\n* Negative immunohistochemistry of STAT3 expression on the tumor tissue sample\n* Diagnosis of another tumor or secondary brain localization\n* In the investigator's judgment, any evidence of severe or uncontrolled systemic disease including: uncontrolled hypertension; hemorrhagic diathesis; active infection with HBV, HCV, HIV. Screening for such chronic conditions is not required by the protocol; bone marrow reserve or organ dysfunction as demonstrated by laboratory tests.\n* Patients who are unable to comply with study procedures and requirements.\n* Contraindication to Brain MRI\n* Pregnant or breastfeeding patients\n* Patients who are unable to swallow capsules or sachets dissolved in water.\n* Patient unable to sign the Informed Consent\n* Glioblastoma leptomeningeal dissemination\n* Congestive heart failure classified as New York Heart Association (NYHA) Class 2 or higher; Unstable angina (symptoms of angina at rest) or new onset angina ≤3 months prior to screening; myocardial infarction \\\u003C6 months prior to 'start of study treatment; cardiac arrhythmias requiring antiarrhythmic therapy, with the exception of beta-blockers or digoxin; uncontrolled hypertension (systolic blood pressure \\[SBP\\]\\>140 mmHg or diastolic blood pressure \\[DBP\\] \\>90 mmHg) despite optimal medical management.\n* Arterial thrombotic or embolic events such as stroke and\u002For transient ischemic attacks) or\n* Pulmonary embolism in the 6 months prior to the start of study treatment\n* Ongoing infection with grade 2 or higher severity (NCI-CTCAE v 5.0)\n* Known history of human immunodeficiency virus (HIV) infection; hepatitis B or C active or chronic requiring treatment with antiviral therapy\n* History of organ allotransplantation\n* Evidence or history of any bleeding diathesis (including mild hemophilia), regardless of its severity;\n* Injuries, ulcers or bone fractures that have not fully resolved.\n* Renal failure requiring hemodialysis or peritoneal dialysis\n* Presenting interstitial lung disease with ongoing signs and symptoms at the time informed consent is obtained.\n* Persistent proteinuria \\>3.5 g\u002F24 hours as measured by urinary protein-creatinine ratio from a urine sample (≥ Grade 3, NCI-CTCAE v 5.0). CTCAE 5.0 is also available in Appendix 1.",{"count":220,"type":21},110,[24],"Multicenter, double-blind, placebo-controlled, randomized trial.\n\nPatients affected by STAT3 positive newly diagnosed glioblastoma will be eligible. Patients are randomized using a stratified block randomization method with a 1:1 ratio in two arms:\n\n• Experimental\u002FControl arm: Concomitant radiotherapy (60 gy in 30 fractions) + temozolomide 75mg\u002Fmq + silibinin\u002Fplacebo 2 sachets\u002Fday dissolved in water throughout concomitant treatment followed by temozolomide cp, 150 mg\u002Fm2-200mg\u002Fm2, g1-5 q28d + silibinin\u002Fplacebo 2 sachets\u002Fday dissolved in water, day 1-28, q28d for 6-12 cycles. Silibinin\u002FPlacebo may be continued until disease progression at the discretion of the physician.\n\nPatients will be stratified based on:\n\n* Type of surgery (complete Vs partial)\n* MGMT methylation status (methylated Vs non-methylated)\n* ECOG PS (0-1 Vs 2)",[224,225],"Glioblastoma","IDH Wild-type and STAT3-positive Glioblastoma",[224,227,228,229,230],"IDH wild-type and STAT3-positive glioblastoma","silibinin","temozolomide","placebo","2025-12-01",{"date":233,"type":37},"2025-12-02",{"date":235,"type":37},"2025-11-12",{"date":237,"type":21},"2027-10",{"name":43,"class":44},16,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":105,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":73},"100588422","preventive-application-of-single-use-negative-pressure-wound-therapy-snpwt-in-the-postoperative-course-of-radiotreatated-limb-sarcoma-surgery-100588422","NCT06941194","Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery","Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery a Randomized Clinical Trial","PRALISS","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs (confirmed histopathologically)\n* performed neoadjuvant radiotherapy (short or long-term)\n* candidates for wide radical excision surgery\n* negative CT scan staging for distant metastasis\n* Signing of Informed consent\n\nExclusion Criteria:\n\n* diagnosis of benign neoplasm\n* diagnosis of retroperitoneal or trunk sarcomas;\n* candidates to hindquarter or forequarter amputation surgery;\n* incomplete wide excision;\n* vascular resection;\n* other loco-regional treatments (e.g. isolated limb perfusion or electrochemotherapy).",{"count":249,"type":21},48,[24],"Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. ECOG performance status will be reported. If inclusion criteria are respected, the patient will be randomized. The application of the PICO14 study device or standard dressing (dry gauze and plaster) will then be carried out on the day of surgery. For subjects randomized to the treatment arm (Arm A), dressing change with the application of the new PICO14 will occur at day 4+1, day 8±1, and day 14±2. For subjects randomized to the control arm (Arm B), the standard dressing with gauze and plaster is applied. Regardless of the randomization arm the wound assessment via ASEPSIS score will occur at day 4+1, 8±1 and 14±2. During FUP, the dressing can be changed autonomously by the patient if necessary. The information will be recorded on the occasion of the next visit or an extraordinary visit. On day 21, sutures will be removed.\n\nOn day 30±2, the total ASEPSIS score will be calculated, in order to evaluate the wound healing.\n\nFrom day 14±2, regardless of the randomization arm all patients will be treated with standard dressing.\n\nFollow-up visits can be scheduled up to 90 days after surgery.",[253,254],"Sarcoma","Sarcoma,Soft Tissue",[256,257,258,259],"sarcoma","limbs","high-grade (grade III) soft tissue sarcoma","PICO14",{"date":233,"type":37},{"date":262,"type":37},"2025-09-15",{"date":264,"type":21},"2027-11",{"name":43,"class":44},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":275,"studyType":57,"phases":4,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100562238","novel-therapeutic-approach-for-human-t-cell-malignancies-100562238","NCT06600568","Novel Therapeutic Approach for Human T-cell Malignancies","Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a Novel Therapeutic Approach for Human T-cell Malignancies","Inclusion Criteria:\n\n* Patients with pre- and post-thymic T-cell leukemia\u002Flymphoma\n* Patients of both sexes\n* Age of patients older than 18 years\n* Patient is willing to provide written and signed informed consent for participation in the study\n\nExclusion Criteria:\n\n-Serious illness or medical condition that does not allow the patient to be managed according to standard treatment protocols, including uncontrolled active infection.",{"count":274,"type":21},120,"2 Years","This multicenter translational study, with prospective and retrospective samples, aims to identify new strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.\n\nInteractions between drugs capable of activating the apoptotic process (e.g., Venetoclax) and drugs capable of altering ROS homeostasis (e.g., inhibitors of the enzyme glucose-6-phosphate dehydrogenase) will be examined.\n\nThe most promising compounds will be selected based on results obtained in vitro on cell lines and PDX already available in the laboratory, and then will be assayed ex vivo in cells obtained from patients with resistant\u002Frefractory T-cell neoplasms.",[278],"T-Cell Leukemia\u002FLymphoma, Adult",[280,281,282,283,284],"T-cell lymphoblastic leukemias (T-ALL)","T-cell non-Hodgkin's lymphomas (T-NHL)","NK cell neoplasia","ROS","apoptosis",{"date":286,"type":37},"2025-12-08",{"date":288,"type":37},"2024-07-01",{"date":290,"type":21},"2026-07-01",{"name":43,"class":44},2,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":303,"conditions":304,"keywords":308,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":323},"100560776","immune-microenvironment-and-gene-expression-profiling-in-mesothelioma-100560776","NCT06581549","Immune Microenvironment and Gene Expression Profiling in Mesothelioma","From Immune Microenvironment Characterization and Gene Expression Profiling to New Drugs Testing in Pleural and Peritoneal Mesothelioma: Imaging-Meso Study","Imaging-Meso","Inclusion Criteria:\n\n* Patients with Mesothelioma of the Pleura and Peritoneum\n* Age greater than 18 years of age\n* Patients undergoing surgery will require both biopsy and surgical sampling material\n* Pathologist's confirmation of the presence of tumor sections in the excised specimens\n* Patients in follow-up from active cancer treatment for at least 6 months\n\nExclusion Criteria:\n\n* Inadequacy of biological material for analysis under study\n* Patients not amenable to active oncologic treatment\n* Patients lost to follow-up before 6 months after the end of active oncologic treatment",{"count":302,"type":21},220,"Pleural and peritoneal mesotheliomas (PPM) are rare cancers mostly related to asbestos-exposure, which are characterized by a complex histopathological diagnosis and staging, few therapeutic options and a dismal prognosis. The main unmet medical need in PPM is the lack of a treatment sequence for affected patients. The advent of immune checkpoint inhibitors has changed the first line treatment of PPM, thanks to the improvement in survival achieved by the combination of ipilimumab and nivolumab that are currently approved for non-epithelioid histology in our Country.\n\nPPM is characterized by a large heterogeneity of the genomic landscape, which is mainly characterized by the loss of tumour suppressor genes and mutations in DNA repair genes and by an \"altered- suppressed\" or \"excluded\" tumor immune microenvironment (TIME).\n\nThe goal of this project is to improve the immune-biological and molecular stratification of PPM subgroups that can lead to the identification of different personalized treatment approaches. PPM patients (N=220) will be retrospectively (N=150) and prospectively (N=70) recruited from the coordinator center and 6 participating Italian centers. Treatment-naïve tumor samples will be collected and analyzed by bulk gene expression and spatial whole transcriptome analysis, and by 9-color multiplex immunofluorescence.\n\nNew targets or actionable pathways potentially emerging from such studies will be finally assessed and validated in patient-derived organoids\u002Fxenografts that accurately reflect PPM tumorigenesis.",[305,306,307],"Mesothelioma","Mesotheliomas Pleural","Mesothelioma; Lung",[309,310,311,312,313,314],"pleura","mesothelioma","PPM patients","lung","Gene expression profiling","Immune microenvironment","2025-09-04",{"date":317,"type":37},"2025-09-05",{"date":319,"type":37},"2023-11-02",{"date":321,"type":21},"2026-12-31",{"name":43,"class":44},10,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":331,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":334,"studyType":57,"phases":4,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":5},"100537093","oligos-impact-of-treatment-on-primary-tumour-in-patients-with-newly-diagnosed-oligometastatic-neoplasia-of-the-prostate-100537093","NCT06273345","OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate","OLIGOS","Inclusion Criteria:\n\n* Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines).\n* Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation\n* Low volume of metastatic disease defined according to CHAARTED study criteria (\\\u003C of 4 bone metastases, absence of visceral metastases)\n* Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT)\n* Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Patients eligible for local treatment of primary malignancy and concomitant systemic therapy\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to give written informed consent\n* High volume metastatic disease defined according to CHARTEED criteria\n* ECOG performance status \\> 1\n* Patients included in other clinical trials\n* Contraindications to hormone\u002Fsystemic therapy administration\n* Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)","MALE",{"count":333,"type":21},150,"3 Years","The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.\n\nThe aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel\u002Fandrogen receptor signal inhibitors (ARTA)).\n\nThe above criteria define 'high metastatic volume' disease with the following parameters\n\n* ≥ 4 bone metastases, including at least one outside the spine and pelvis\n* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics.",[337],"Oligometastatic Prostate Carcinoma","2025-04-16",{"date":340,"type":37},"2025-04-17",{"date":342,"type":37},"2023-01-23",{"date":344,"type":21},"2026-01",{"name":43,"class":44},""]