[{"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":152,"leadSponsor":154,"locationsCount":155},{"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 prostate dose escalation using one of the following protocol-defined modalities: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction stereotactic body radiotherapy 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 prostate dose escalation using one of the following protocol-defined modalities: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction stereotactic body radiotherapy 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 prostate dose escalation delivered after completion of ultrahypofractionated whole-pelvis radiotherapy. The prostate boost is delivered using one of the following protocol-defined modalities according to institutional expertise: high-dose-rate brachytherapy (15 Gy in 1 fraction), low-dose-rate brachytherapy (110 Gy permanent implant), or single-fraction stereotactic body radiotherapy 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},1600,"ESTIMATED","INTERVENTIONAL",[125,126],"PHASE2","PHASE3","Patients with prostate cancer and pelvic lymph node involvement (cN1M0) identified on PSMA PET imaging represent a biologically aggressive yet potentially curable disease population. Contemporary management relies on multimodality treatment combining definitive radiotherapy to the prostate and pelvic lymph nodes with long-term androgen deprivation therapy (ADT), often intensified with androgen receptor pathway inhibitors. Despite these advances, a substantial proportion of patients still develop distant metastatic disease, highlighting the need to optimize local-regional treatment strategies in the era of molecular imaging.\n\nThe introduction of PSMA PET has fundamentally altered staging accuracy in prostate cancer, enabling earlier and more precise detection of pelvic nodal disease. However, most existing evidence guiding radiotherapy dose prescription in node-positive prostate cancer originates from the pre-PSMA era. As a result, it remains unclear how best to integrate prostate-directed and nodal-directed dose escalation strategies when disease extent is defined by modern molecular imaging. In particular, it is unknown whether long-term disease control is primarily driven by durable intraprostatic tumor eradication, by aggressive treatment of involved lymph nodes, or by a combination of both.\n\nPRO-BOOST-N is a prospective, multicenter, randomized phase II\u002FIII clinical trial designed to address this critical evidence gap. The trial evaluates prostate-first versus combined prostate and nodal dose escalation strategies in patients with PSMA PET-staged node-positive (cN1M0) prostate cancer treated within a standardized ultrahypofractionated whole-pelvis radiotherapy framework. All enrolled patients indicated for definitive treatment undergo mandatory baseline PSMA PET\u002FCT to confirm pelvic lymph node involvement and exclude distant metastatic disease.\n\nAll patients receive a uniform radiotherapy backbone consisting of ultrahypofractionated whole-pelvis radiotherapy delivered in five fractions, combined with long-term ADT. Use of androgen receptor pathway inhibitors is permitted and encouraged according to contemporary clinical practice and local availability, ensuring the relevance of the trial to real-world treatment settings.\n\nUsing a 2×2 factorial randomized design, PRO-BOOST-N evaluates two independent treatment factors. The primary randomized comparison assesses whether ablative prostate dose escalation improves oncologic outcomes compared with contemporary SBRT-based definitive prostate radiotherapy without additional boost. Prostate dose escalation may be delivered using one of three protocol-defined modalities-high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT-according to institutional expertise. This comparison directly tests the hypothesis that durable intraprostatic disease control is the dominant determinant of long-term systemic disease suppression in node-positive prostate cancer.\n\nThe key secondary, hierarchically tested comparison evaluates the role of nodal dose escalation by comparing two predefined dose levels delivered to PSMA PET-positive pelvic lymph nodes. These dose levels reflect intermediate versus higher nodal boost strategies based on biologically effective dose concepts specific to prostate cancer radiobiology. To ensure patient safety and protocol feasibility, organ-at-risk-driven nodal dose de-escalation is permitted within the higher-dose arm, without altering randomization assignment.\n\nThe primary endpoint of the trial is metastasis-free survival. Secondary endpoints include overall survival, radiographic progression-free survival assessed primarily using PSMA PET imaging, intraprostatic and regional nodal control, time to castration-resistant prostate cancer, time to next systemic therapy, treatment-related toxicity graded according to CTCAE version 5.0, and patient-reported outcomes assessing urinary, bowel, sexual, and global quality of life.\n\nBy prospectively and hierarchically evaluating prostate and nodal dose escalation strategies within a modern PSMA PET-guided and ultrahypofractionated radiotherapy platform, PRO-BOOST-N aims to define the optimal radiotherapy intensification approach for patients with node-positive prostate cancer. The results of this study are expected to directly inform clinical practice, guideline development, and future treatment individualization in the PSMA PET era.",[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","2026-03-19",{"date":149,"type":150},"2026-03-23","ACTUAL",{"date":147,"type":150},{"date":153,"type":122},"2035-12-01",{"name":5,"class":6},1]