[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625704":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":78,"centralContacts":82,"locations":89,"responsibleParty":107,"collaborators":73,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":73,"enrollmentInfo":120,"targetDuration":73,"studyType":123,"phases":124,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":92,"whyStopped":73,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",[8,18,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: A0B1 - No Prostate Boost + Intermediate Nodal Dose","EXPERIMENTAL","Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) with a simultaneous integrated boost to the prostate delivering 36.25 Gy in 5 fractions, without additional prostate boost. PSMA PET-positive pelvic lymph nodes receive an intermediate nodal dose escalation (27.75 Gy in 5 fractions). All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.",[13,14,15,16,17],"Radiation: Ultrahypofractionated Whole-Pelvis Radiotherapy","Radiation: SBRT-Based Prostate Radiotherapy (No Boost)","Radiation: Intermediate Nodal Dose Escalation","Drug: Androgen Deprivation Therapy (ADT)","Drug: Androgen Receptor Pathway Inhibitors (ARPIs)",{"label":19,"type":10,"description":20,"interventionNames":21},"Arm 2: A0B2 - No Prostate Boost + Higher Nodal Dose","Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) with a simultaneous integrated boost to the prostate delivering 36.25 Gy in 5 fractions, without additional prostate boost. PSMA PET-positive pelvic lymph nodes receive a higher nodal dose escalation (30 Gy in 5 fractions), with protocol-defined organ-at-risk-driven dose de-escalation permitted if required. All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.",[13,14,22,16,17],"Radiation: Higher Nodal Dose Escalation",{"label":24,"type":10,"description":25,"interventionNames":26},"Arm 3: A1B1 - Prostate Boost + Intermediate Nodal Dose","Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) to the prostate and pelvic lymph nodes, followed by ablative whole-gland prostate dose escalation. The prostate boost modality is assigned before main randomization: if two or more modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is prospectively assigned. Protocol-defined boost modalities include high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost. PSMA PET-positive pelvic lymph nodes receive an intermediate nodal dose escalation (27.75 Gy in 5 fractions). All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.",[13,27,15,16,17],"Radiation: Ablative Prostate Boost",{"label":29,"type":10,"description":30,"interventionNames":31},"Arm 4: A1B2 - Prostate Boost + Higher Nodal Dose","Participants receive ultrahypofractionated whole-pelvis radiotherapy (25 Gy in 5 fractions) to the prostate and pelvic lymph nodes, followed by ablative whole-gland prostate dose escalation. The prostate boost modality is assigned before main randomization: if two or more modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is prospectively assigned. Protocol-defined boost modalities include high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost. PSMA PET-positive pelvic lymph nodes receive a higher nodal dose escalation (30 Gy in 5 fractions), with protocol-defined organ-at-risk-driven dose de-escalation permitted if required. All patients receive long-term androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.",[13,27,22,16,17],[33,40,47,54,61,68,74],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"RADIATION","Ultrahypofractionated Whole-Pelvis Radiotherapy","Whole-pelvis external beam radiotherapy delivered using VMAT or IMRT techniques to elective pelvic lymph node volumes and the prostate. Treatment is prescribed as 25 Gy in 5 fractions and delivered with daily image guidance, serving as the standardized radiotherapy backbone for all study arms.",[9,19,24,29],[39],"Whole-Pelvis Radiotherapy (WPRT)",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"SBRT-Based Prostate Radiotherapy (No Boost)","Definitive prostate radiotherapy delivered as a simultaneous integrated boost within the ultrahypofractionated whole-pelvis radiotherapy plan. The prostate receives a total dose of 36.25 Gy in 5 fractions without additional prostate boost beyond this dose.",[9,19],[45,46],"Definitive Prostate SBRT","Prostate SBRT 36.25 Gy",{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Ablative Prostate Boost","Ablative whole-gland prostate dose escalation delivered after completion of ultrahypofractionated whole-pelvis radiotherapy. The prostate boost modality is prospectively assigned before main randomization. If two or more protocol-defined boost modalities are available and technically suitable, the modality is assigned by embedded subrandomization; if only one modality is feasible, that modality is assigned as the single feasible option. Boost modalities include high-dose-rate brachytherapy (15 Gy in 1 fraction), low-dose-rate brachytherapy (110 Gy permanent implant), or single-fraction SBRT boost (15 Gy in 1 fraction).",[24,29],[52,53],"Prostate Boost Radiotherapy","Whole-Gland Prostate Boost",{"type":34,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Intermediate Nodal Dose Escalation","Dose escalation to PSMA PET-positive pelvic lymph nodes delivered using a simultaneous integrated boost technique within the ultrahypofractionated whole-pelvis radiotherapy plan. The prescribed nodal boost dose is 27.75 Gy in 5 fractions.",[9,24],[59,60],"PSMA PET-Guided Nodal Boost (Intermediate Dose)","Pelvic Nodal SIB 27.75 Gy",{"type":34,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Higher Nodal Dose Escalation","Dose escalation to PSMA PET-positive pelvic lymph nodes delivered using a simultaneous integrated boost technique within the ultrahypofractionated whole-pelvis radiotherapy plan. The prescribed nodal boost dose is 30 Gy in 5 fractions, with protocol-defined organ-at-risk-driven dose de-escalation permitted if required.",[19,29],[66,67],"PSMA PET-Guided Nodal Boost (High Dose)","Pelvic Nodal SIB 30 Gy",{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","Androgen Deprivation Therapy (ADT)","Androgen deprivation therapy administered as long-term systemic treatment in all study arms. ADT is delivered using luteinizing hormone-releasing hormone (LHRH) agonists or antagonists according to institutional practice and protocol-defined duration. ADT is initiated before or during radiotherapy and continued after completion of radiotherapy as specified in the study protocol.",[9,19,24,29],null,{"type":69,"name":75,"description":76,"armGroupLabels":77,"otherNames":73},"Androgen Receptor Pathway Inhibitors (ARPIs)","Androgen receptor pathway inhibitors may be administered in combination with androgen deprivation therapy according to contemporary clinical practice, local availability, and patient-specific considerations. The use of ARPIs is permitted but not randomized and includes approved agents targeting androgen receptor signaling.",[9,19,24,29],[79],{"name":80,"affiliation":5,"role":81},"Mateusz Bilski, MD, PhD","PRINCIPAL_INVESTIGATOR",[83,87],{"name":80,"role":84,"phone":85,"phoneExt":73,"email":86},"CONTACT","048 84 535 99 10","bilskimat@gmail.com",{"name":88,"role":84,"phone":85,"phoneExt":73,"email":86},"Mateusz Bilski, MD,PhD",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Affidea Nu-Med, Center of Oncological Diagnostics and Therapy","RECRUITING","Zamość","Lublin Voivodeship","22-400","Poland","PL",{"type":99,"coordinates":100},"Point",[101,102],23.25196,50.72314,{"lat":102,"lon":101},[105],{"name":106,"role":84,"phone":85,"phoneExt":73,"email":86},"Mateusz Edward Bilski, MD, PhD",{"type":81,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":73,"oldOrganization":73},"Mateusz Bilski","MD, PhD","100625704","phase-2-pro-boost-n-prostate-first-versus-combined-prostate-and-nodal-dose-escalation-in-psma-pet-staged-node-positive-prostate-cancer-100625704",false,"NCT07426094","PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer","PRO-BOOST-N: A Randomized Phase II\u002FIII Trial Evaluating Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate Cancer Using an Ultrahypofractionated Whole-Pelvis Radiotherapy Platform","PRO-BOOST-N","Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Prostate cancer with clinically positive pelvic lymph nodes (cN1) without evidence of distant metastatic disease.\n* Pelvic lymph node involvement limited to regional pelvic lymph nodes (obturator, internal iliac, external iliac, presacral), as assessed by conventional imaging and\u002For PSMA PET\u002FCT.\n* No evidence of distant metastatic disease (M0), including absence of non-regional nodal, bone, or visceral metastases.\n* Candidate for definitive radiotherapy to the prostate and elective pelvic lymph nodes.\n* Planned treatment with androgen deprivation therapy with or without androgen receptor pathway inhibitors according to protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function allowing delivery of protocol-defined radiotherapy and systemic therapy.\n* Age ≥18 years.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease (M1), including non-regional lymph node, bone, or visceral metastases.\n* Prior definitive local therapy for prostate cancer, including radical prostatectomy, whole-gland radiotherapy, or brachytherapy.\n* Prior pelvic radiotherapy for any indication that would overlap planned treatment fields.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant androgen deprivation therapy.\n* History of castration-resistant prostate cancer.\n* Concurrent malignancy requiring active treatment, except non-melanoma skin cancer or other malignancies with negligible risk of interference with study outcomes.\n* Severe uncontrolled comorbidities that would preclude safe delivery of radiotherapy or systemic therapy.\n* Any condition that, in the opinion of the investigator, would interfere with patient safety or compliance with the study protocol.","MALE","18 Years",{"count":121,"type":122},600,"ESTIMATED","INTERVENTIONAL",[125,126],"PHASE2","PHASE3","PRO-BOOST-N is a prospective, multicenter, randomized phase II\u002FIII clinical trial for patients with prostate cancer and pelvic lymph node involvement (cN1M0) confirmed by PSMA PET\u002FCT, without distant metastatic disease.\n\nPatients with PSMA PET-staged node-positive prostate cancer are potentially curable, but remain at substantial risk of distant progression despite contemporary treatment with radiotherapy, long-term androgen deprivation therapy, and, when appropriate, androgen receptor pathway inhibitors. The optimal way to intensify radiotherapy to the prostate and PSMA PET-positive pelvic lymph nodes remains uncertain in the era of modern molecular imaging.\n\nAll participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy backbone delivered in five fractions, combined with long-term systemic therapy according to contemporary clinical practice. The study uses a 2 x 2 factorial randomized design to evaluate two treatment questions.\n\nThe primary comparison evaluates whether prostate dose escalation improves metastasis-free survival compared with no additional prostate boost. Patients assigned to prostate boost receive one of three protocol-defined boost techniques: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT. If more than one prostate boost technique is available at the treating center and technically suitable for the patient, the boost technique is assigned by embedded subrandomization.\n\nThe key secondary, hierarchically tested comparison evaluates nodal dose escalation by comparing two predefined dose levels to PSMA PET-positive pelvic lymph nodes. Organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm when required for patient safety and protocol compliance.\n\nThe primary endpoint is metastasis-free survival (MFS) . Secondary endpoints include overall survival (OS), radiographic progression-free survival (rPFS), intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related adverse events graded according to CTCAE version 6.0, and patient-reported quality of life, including urinary, bowel, sexual, and global health domains.\n\nPRO-BOOST-N aims to determine the optimal radiotherapy intensification strategy for patients with PSMA PET-staged node-positive prostate cancer by prospectively evaluating prostate-directed and nodal-directed dose escalation within a modern, standardized radiotherapy platform.",[129,130,131,132,133],"Prostate Cancer","Brachytherapy","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors","Regionally Advanced Prostate Cancer",[135,136,137,130,138,139,140,141,142,143,144,145,146],"Radiotherapy","Stereotactic Body Radiotherapy","SBRT","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Nodal metastases","Metastases","2026-07-18",{"date":149,"type":150},"2026-07-21","ACTUAL",{"date":152,"type":150},"2026-03-19",{"date":154,"type":122},"2035-12-01",{"name":5,"class":6},1]