[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625701":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":60,"centralContacts":65,"locations":71,"responsibleParty":89,"collaborators":38,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":38,"enrollmentInfo":102,"targetDuration":38,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":74,"whyStopped":38,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",[8,15,22,27],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT Monotherapy","ACTIVE_COMPARATOR","Patients assigned to this arm receive definitive stereotactic body radiotherapy (SBRT) delivered to the prostate as monotherapy, without any additional intraprostatic boost. Treatment is administered using an ultrahypofractionated regimen with highly conformal dose delivery, daily image guidance, and motion management according to protocol-defined standards. Target volumes and organs at risk are contoured following centralized guidelines, and treatment planning adheres to predefined coverage objectives and dose constraints. This arm represents a contemporary, non-invasive definitive radiotherapy strategy for localized prostate cancer and serves as the active comparator for all boost-based dose escalation approaches evaluated in the study. Androgen deprivation therapy may be administered according to protocol-defined risk group and current clinical practice guidelines.",[13,14],"Radiation: Stereotactic Body Radiotherapy (SBRT) Monotherapy","Drug: Androgen Deprivation Therapy (ADT)",{"label":16,"type":17,"description":18,"interventionNames":19},"EBRT With HDR Brachytherapy Boost","EXPERIMENTAL","Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate using modern image-guided techniques, followed by an intraprostatic boost delivered with high-dose-rate (HDR) brachytherapy. The EBRT component provides uniform baseline irradiation, after which a single-fraction HDR brachytherapy boost is administered using transperineal catheter placement and afterloading according to protocol-defined technical and dosimetric criteria. This approach enables delivery of a very high biologically effective dose to the prostate while maintaining strict organ-at-risk constraints. Target coverage objectives, applicator placement principles, and dose limits are standardized across centers. Androgen deprivation therapy may be administered according to protocol-defined risk group and standard clinical practice.",[20,21,14],"Radiation: External Beam Radiotherapy (EBRT) Backbone","Radiation: High-Dose-Rate Brachytherapy Boost",{"label":23,"type":17,"description":24,"interventionNames":25},"EBRT With LDR Brachytherapy Boost","Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate, followed by an intraprostatic boost using low-dose-rate (LDR) permanent seed brachytherapy. After completion of EBRT, LDR brachytherapy is performed with transperineal implantation of radioactive seeds according to protocol-defined planning, implantation, and post-implant dosimetric criteria. This strategy achieves dose escalation through continuous low-dose-rate irradiation while respecting predefined target coverage goals and organ-at-risk constraints. Implant quality and dosimetry are centrally specified to ensure consistency across participating centers. Androgen deprivation therapy may be administered based on protocol-defined risk group and standard clinical practice.",[20,26,14],"Radiation: Low-Dose-Rate Brachytherapy Boost",{"label":28,"type":17,"description":29,"interventionNames":30},"EBRT With SBRT Boost","Patients assigned to this arm receive a standardized ultrahypofractionated external beam radiotherapy (EBRT) backbone delivered to the prostate, followed by an intraprostatic stereotactic body radiotherapy (SBRT) boost. The EBRT component establishes baseline target coverage, after which a highly conformal SBRT boost is delivered in a single fraction using advanced image guidance and motion management. This arm represents a fully non-invasive dose escalation strategy that avoids brachytherapy while enabling delivery of a high biologically effective intraprostatic dose. Treatment planning and delivery follow protocol-defined target coverage objectives and organ-at-risk constraints to ensure safety and consistency. Androgen deprivation therapy may be administered according to protocol-defined criteria.",[20,31,14],"Radiation: Stereotactic Body Radiotherapy (SBRT) Boost",[33,39,43,47,51,55],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"RADIATION","Stereotactic Body Radiotherapy (SBRT) Monotherapy","Stereotactic body radiotherapy (SBRT) delivered to the prostate as definitive monotherapy using an ultrahypofractionated schedule. Treatment is planned with highly conformal techniques and daily image guidance according to protocol-defined target coverage objectives and organ-at-risk constraints. This intervention represents a non-invasive definitive radiotherapy strategy without additional intraprostatic boost.",[9],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"External Beam Radiotherapy (EBRT) Backbone","Ultrahypofractionated external beam radiotherapy delivered to the prostate using volumetric modulated arc therapy (VMAT) or equivalent intensity-modulated techniques. This intervention serves as a standardized treatment backbone prior to intraprostatic dose escalation and is delivered according to protocol-defined target volumes, margins, and dose constraints.",[16,23,28],{"type":34,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"High-Dose-Rate Brachytherapy Boost","Intraprostatic high-dose-rate brachytherapy delivered as a single-fraction boost following completion of external beam radiotherapy. The procedure involves transperineal catheter placement with afterloading and is performed according to protocol-defined technical, dosimetric, and safety criteria to achieve focal dose escalation while respecting organ-at-risk constraints.",[16],{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"Low-Dose-Rate Brachytherapy Boost","Intraprostatic low-dose-rate permanent seed brachytherapy delivered as a boost following completion of external beam radiotherapy. Radioactive seeds are implanted transperineally according to protocol-defined planning and implantation guidelines to provide continuous low-dose-rate irradiation while maintaining predefined target coverage and organ-at-risk constraints.",[23],{"type":34,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"Stereotactic Body Radiotherapy (SBRT) Boost","Intraprostatic stereotactic body radiotherapy delivered as a single-fraction boost following completion of external beam radiotherapy. This intervention provides non-invasive dose escalation using highly conformal planning and image guidance according to protocol-defined coverage objectives and organ-at-risk constraints.",[28],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":38},"DRUG","Androgen Deprivation Therapy (ADT)","Androgen deprivation therapy (ADT) administered according to protocol-defined risk group and standard clinical practice. ADT may include luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, with or without short-course antiandrogens, delivered as neoadjuvant, concurrent, and\u002For adjuvant therapy in accordance with contemporary clinical guidelines. ADT is not randomized and is applied uniformly within each risk group across all treatment arms.",[16,23,28,9],[61],{"name":62,"affiliation":63,"role":64},"Mateusz Bilski, MD PhD","Affidea Nu-Med, Center of Oncological Diagnostics and Therapy, Zamość, Poland","PRINCIPAL_INVESTIGATOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":38,"email":70},"Mateusz Edward Bilski, MD, PhD","CONTACT","048 84 535 99 10","bilskimat@gmail.com",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Affidea Nu-Med, Center of Oncological Diagnostics and Therapy","RECRUITING","Zamość","Lublin Voivodeship","22-400","Poland","PL",{"type":81,"coordinates":82},"Point",[83,84],23.25196,50.72314,{"lat":84,"lon":83},[87,88],{"name":67,"role":68,"phone":69,"phoneExt":38,"email":70},{"name":67,"role":64,"phone":38,"phoneExt":38,"email":38},{"type":64,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Mateusz Bilski","Medical Director and Head of Radiotherapy Department, MD, PhD","100625701","phase-2-pro-boost-lc-whole-gland-boost-strategies-versus-sbrt-monotherapy-in-psma-staged-localized-and-locally-advanced-prostate-cancer-100625701",false,"NCT07426055","PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer","PRO-BOOST-LC: A Prospective, Multi-arm Phase II\u002FIII Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET\u002FCT","PRO-BOOST-LC","Inclusion Criteria:\n\n* Male patients aged ≥18 years.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.\n* Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.\n* NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.\n* Candidate for definitive radiotherapy with curative intent.\n* ECOG performance status 0-2.\n* Baseline PSA available prior to randomization.\n* Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.\n* Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.\n* Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.\n* Prior pelvic radiotherapy for any malignancy.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.\n* History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).\n* Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.\n* Severe uncontrolled comorbidities that would preclude protocol treatment.\n* Inability to comply with study procedures or follow-up schedule.","MALE","18 Years",{"count":103,"type":104},1000,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE2","PHASE3","PRO-BOOST-LC is a prospective, multicenter, randomized phase II\u002FIII clinical trial for men with localized or locally advanced prostate cancer without lymph node or distant metastases, confirmed using prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography (PSMA PET\u002FCT).\n\nRadiotherapy is an established curative treatment option for prostate cancer. Several modern radiotherapy strategies can safely deliver high radiation doses to the prostate while limiting dose to surrounding organs. These include stereotactic body radiotherapy (SBRT), high-dose-rate (HDR) brachytherapy, low-dose-rate (LDR) brachytherapy, and combinations of external beam radiotherapy with a prostate boost. However, the optimal dose-escalation strategy for balancing cancer control, treatment-related toxicity, and long-term quality of life remains uncertain in patients staged with modern PSMA PET imaging.\n\nThe aim of PRO-BOOST-LC is to compare definitive SBRT monotherapy with whole-gland prostate boost strategies delivered after a short course of external beam radiotherapy. Participants will be randomly assigned, according to center capability and patient-level technical suitability, to one of the protocol-defined treatment options. The control group receives SBRT monotherapy. The experimental groups receive external beam radiotherapy followed by one of three whole-gland boost techniques: HDR brachytherapy, LDR brachytherapy, or single-fraction SBRT boost.\n\nThe primary objective is to determine whether assignment to a prostate boost strategy improves failure-free survival compared with SBRT monotherapy. Failure-free survival includes biochemical recurrence, local or regional progression, distant metastases, progression-driven salvage treatment, or death from any cause. Key secondary outcomes include metastasis-free survival, overall survival, physician-reported treatment-related toxicity, and patient-reported quality of life, including urinary, bowel, and sexual function.\n\nParticipants will undergo baseline clinical evaluation, PSA testing, prostate MRI, PSMA PET\u002FCT, and quality-of-life assessments. After treatment, participants will be followed regularly with clinical assessments, PSA testing, toxicity evaluation, patient questionnaires, and imaging when clinically indicated. The study is designed to provide long-term evidence on how best to use modern radiotherapy dose escalation for patients with PSMA-staged localized or locally advanced prostate cancer.",[111,112,113,114,115],"Prostate Cancer (Adenocarcinoma)","Prostate Brachytherapy","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors","Localized Prostate Cancer",[117,118,119,120,121,122,123,124,125,126,127,128],"Radiotherapy","Stereotactic Body Radiotherapy","SBRT","Brachytherapy","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Failure-Free Survival","2026-07-18",{"date":131,"type":132},"2026-07-21","ACTUAL",{"date":134,"type":132},"2026-03-19",{"date":136,"type":104},"2035-12",{"name":5,"class":6},1]