[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554245":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":53,"responsibleParty":350,"collaborators":352,"id":356,"slug":357,"hasResults":358,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":47,"eligibilityCriteria":362,"healthyVolunteers":358,"sex":363,"minAge":364,"maxAge":365,"enrollmentInfo":366,"targetDuration":47,"studyType":369,"phases":370,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":157,"whyStopped":47,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":390},{"fullName":5,"class":6},"UNICANCER","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Control arm): Standard of Care (SoC) alone","ACTIVE_COMPARATOR","The SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization and continued at least until the CRPC stage is reached.:\n\n* ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª\n* ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª\n\nª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based and completed at least 4 weeks ahead of randomization OR planned right after randomization in arm A.\n\nᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization.",[13],"Drug: Standard of Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (Experimental arm): 177Lu-PMSA-617 + SoC","EXPERIMENTAL","Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles. Upon 177Lu-PMSA-617 treatment completion, the ongoing standard systemic treatment is to be maintained and continued at least until the CRPC stage is reached.\n\nThe SoC is defined as one the following treatment which was initiated 6 to 8 months ahead of inclusion in this trial and still ongoing at the time of the randomization:\n\n* ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapyª\n* ADT with docetaxelᵇ plus an ARSI (i.e. abiraterone + prednisone, or darolutamide,) ± radiotherapyª\n\nª Radiotherapy can be part of any standard treatment aforementioned as long as it is not PSMA-based completed at least 4 weeks ahead of randomization OR planned right after 177Lu-PSMA-617 in arm B.\n\nᵇ Whenever docetaxel was part of the systemic treatment initiation, its administration must have been completed at least 4 weeks ahead of randomization.",[19,13],"Drug: 177Lu-PMSA-617",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","177Lu-PMSA-617","Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles.",[15],[27],"Pluvicto®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard of Care","ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care",[9,15],[33],"ADT with an ARSI (i.e. abiraterone + prednisone, or apalutamide, or enzalutamide) ± radiotherapy* or ADT with docetaxel* plus an ARSI (i.e abiraterone + prednisone, or darolutamide,) ± radiotherapy",[35,39],{"name":36,"affiliation":37,"role":38},"Karim FIZAZI, MD","Gustave Roussy, Villejuif","STUDY_CHAIR",{"name":40,"affiliation":41,"role":38},"Gwenaelle GRAVIS, MD","IPC, Marseille",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Florence TANTOT","CONTACT","+33 (1) 73.77.55.43",null,"f-tantot@unicancer.fr",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Catherine LEGER","+33 (7) 79.83.23.98","c-leger@unicancer.fr",[54,71,83,95,107,119,131,143,155,168,180,192,204,214,223,235,247,256,267,278,290,302,314,326,338],{"facility":55,"status":56,"city":57,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Institut de Cancérologie de l'Ouest","NOT_YET_RECRUITING","Angers","France","FR",{"type":61,"coordinates":62},"Point",[63,64],-0.55202,47.47156,{"lat":64,"lon":63},[67,69],{"name":68,"role":45,"phone":47,"phoneExt":47,"email":47},"Elouen Boughalem, MD",{"name":68,"role":70,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"facility":72,"status":56,"city":73,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Institut 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Marquis","Rennes",{"type":61,"coordinates":227},[228,229],-1.67431,48.11109,{"lat":229,"lon":228},[232,234],{"name":233,"role":45,"phone":47,"phoneExt":47,"email":47},"Laurence Crouzet, MD",{"name":233,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":236,"status":56,"city":237,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"Centre Henri Becquerel","Rouen",{"type":61,"coordinates":239},[240,241],1.09932,49.44313,{"lat":241,"lon":240},[244,246],{"name":245,"role":45,"phone":47,"phoneExt":47,"email":47},"David Tonnelet, MD",{"name":245,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":248,"status":56,"city":237,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":249,"geoPoint":251,"contacts":252},"CHU Rouen",{"type":61,"coordinates":250},[240,241],{"lat":241,"lon":240},[253,255],{"name":254,"role":45,"phone":47,"phoneExt":47,"email":47},"Laetitia Augusto, 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Etienne","Saint-Priest-en-Jarez",{"type":61,"coordinates":282},[283,284],4.37678,45.4739,{"lat":284,"lon":283},[287,289],{"name":288,"role":45,"phone":47,"phoneExt":47,"email":47},"Pierre Cornillon, MD",{"name":288,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":291,"status":56,"city":292,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"ICANS","Strasbourg",{"type":61,"coordinates":294},[295,296],7.74553,48.58392,{"lat":296,"lon":295},[299,301],{"name":300,"role":45,"phone":47,"phoneExt":47,"email":47},"Philippe Barthelemy, MD",{"name":300,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":303,"status":56,"city":304,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"IUCT Oncopole","Toulouse",{"type":61,"coordinates":306},[307,308],1.44367,43.60426,{"lat":308,"lon":307},[311,313],{"name":312,"role":45,"phone":47,"phoneExt":47,"email":47},"Loic Mourey, MD",{"name":312,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":315,"status":56,"city":316,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"CHRU Tours","Tours",{"type":61,"coordinates":318},[319,320],0.70398,47.39484,{"lat":320,"lon":319},[323,325],{"name":324,"role":45,"phone":47,"phoneExt":47,"email":47},"Mathilde Cancel, MD",{"name":324,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":327,"status":56,"city":328,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Institut de Cancérologie de Lorraine","Vandœuvre-lès-Nancy",{"type":61,"coordinates":330},[331,332],6.17114,48.66115,{"lat":332,"lon":331},[335,337],{"name":336,"role":45,"phone":47,"phoneExt":47,"email":47},"Vincent MASSARD, MD",{"name":336,"role":70,"phone":47,"phoneExt":47,"email":47},{"facility":339,"status":157,"city":340,"state":47,"zip":47,"country":58,"countryCode":59,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"Gustave Roussy","Villejuif",{"type":61,"coordinates":342},[343,344],2.35992,48.7939,{"lat":344,"lon":343},[347,348],{"name":36,"role":45,"phone":47,"phoneExt":47,"email":47},{"name":349,"role":70,"phone":47,"phoneExt":47,"email":47},"Karim Fizazi, MD",{"type":351,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[353],{"name":354,"class":355},"Novartis","INDUSTRY","100554245","phase-3-standard-of-care---177lu-psma-617-in-de-novo-mhspc-patients-with-poor-psa-response-peace6-poor-responders-100554245",false,"NCT06496581","Standard of Care +\u002F- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)","A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care +\u002F- 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA≥0.2 ng\u002FmL at 6-8 Months After Systemic Treatment Initiation","Inclusion Criteria:\n\nAll of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements:\n\n1. Signed a written informed consent form prior to any trial specific procedures.\n\n   Note: In case of physical incapacitation, a trusted representative of their choice, which is not the Investigator or sponsor, can sign on the behalf of the patients.\n2. Aged ≥18 years old\n3. Life expectancy \\> 6 months as per investigator estimate\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n5. Men with histologically or cytologically confirmed adenocarcinoma of the prostate\n6. De novo metastatic disease defined by clinical or radiographic evidence of metastases at diagnosis (i.e. before any treatment started). If not available, a more recent imaging can be used\n7. Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients with doubtful bone metastases are not eligible\n8. A pre-randomization 68Ga-PSMA-11 PET\u002FCT scan performed within 4 weeks prior to randomization in the trial.\n\n   FDG PET scan is not required for this protocol. All patients will be treated independently from the results of pre-randomization PSMA PET scan: patients with PSMA-positive or PSMA-negative disease according to PROMISE 2.0 criteria are eligible.\n9. Have 6 to 8 months of previous AND ongoing standard systemic treatment for prostate cancer consisting in either:\n\n   * ADT with an androgen receptor signaling inhibitor (ARSI) (i.e., abiraterone (plus prednisone), or apalutamide or enzalutamide) ± radiotherapy \\*\\*\n   * ADT with docetaxel\\* plus an ARSI (i.e. abiraterone (plus prednisone), or darolutamide,) ± radiotherapy\\*\\*\n\n   Note:\n\n   \\*Docetaxel must have been stopped at least 4 weeks ahead of randomization.\n\n   \\*\\* Previous radiotherapy to the primary tumor and\u002For to the metastases is accepted as long as it was not PSMA-based and must has been completed at least 4 weeks ahead of randomization.\n10. Stable or declining PSA level but not a rising one\n11. Serum PSA of ≥ 0.2 ng\u002FmL at 6 to 8 months after systemic treatment initiation\n12. Testosterone level \\\u003C 50 ng\u002Fdl or \\\u003C 1.7 nmol\u002FL\n13. Be fit enough for 177Lu-vipivotide tetraxetan treatment:\n\n    * Adequate bone marrow function: hemoglobin ≥90 g\u002FL (in absence of red blood cell transfusion within 4 weeks prior to randomization), absolute neutrophil count ≥1.5 x10⁹\u002FL, platelet count \\>100 x10⁹\u002FL\n    * Adequate liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or ≤ 5.0 x ULN in the presence of liver metastases; bilirubin \\\u003C1.5 x ULN (unless known or suspected Gilbert syndrome, then \\\u003C3 x ULN is permitted)\n    * Adequate renal function: calculated creatinine clearance ≥ 50 ml\u002Fmin (using the MDRD or CKD EPI method).\n14. For sexually active men with female partners of reproductive potential or with pregnant women, agreement to use a condom with another effective contraceptive method during trial participation and up to 14 weeks after study treatment completion.\n15. Affiliated to the social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).\n16. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\nPatients presenting with any of the following criteria are not eligible:\n\n1. Any evidence of cancer progression (including a rising PSA level, clinical progression, or radiological progression)\n2. Prior or concurrent PSMA-based radioligand therapy or other PSMA target treatments\n3. Known hypersensitivity to the components of the study therapy or its analogs\n4. Any condition preventing the use of the standard of care and\u002For specific experimental treatments tested in the trial\n5. Any of the following within 6 months before randomization: stroke, myocardial infraction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, congestive heart failure New York Heart Association (NYHA) Class III or IV\n6. Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \\[sBP\\] ≥ 160 mmHg or diastolic blood pressure \\[dBP\\] ≥ 95 mmHg, 3 consecutive measures taken 5 minutes apart)\n7. Severe or uncontrolled concurrent disease, infection or co-morbidity\n8. Pathological findings consistent with small cell carcinoma of the prostate\n9. History of malignancy within 3 years of the current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma\n10. Ongoing participation in another clinical trial involving an investigational product.. Treatment with an investigational product must have ended within 28 days prior to the day of randomization\n11. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n12. Persons deprived of their liberty or under protective custody or guardianship","MALE","18 Years","80 Years",{"count":367,"type":368},500,"ESTIMATED","INTERVENTIONAL",[371],"PHASE3","PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who do not present with a satisfactory response characterized by a serum prostatic specific antigen (PSA) level of ≥ 0.2 ng\u002FmL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level).",[374],"Prostate Cancer Metastatic",[376,377,378,379,380],"Genital Diseases, Male","Prostatic Diseases","Hormones","177Lu-PSMA-617","PSA","2024-12-17",{"date":383,"type":384},"2024-12-20","ACTUAL",{"date":386,"type":384},"2024-09-12",{"date":388,"type":368},"2039-08-01",{"name":5,"class":6},25]