[{"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":134,"leadSponsor":136,"locationsCount":137},{"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},1200,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE2","PHASE3","PRO-BOOST-LC is a prospective, multicenter, randomized clinical trial designed for patients with localized prostate cancer who do not have evidence of lymph node or distant metastases based on modern PSMA PET imaging.\n\nProstate cancer is one of the most common cancers in men. For patients with disease confined to the prostate, radiotherapy is a well-established and effective curative treatment option. Over the past decades, research has shown that delivering higher radiation doses to the prostate can improve cancer control and reduce the risk of disease recurrence. However, higher radiation doses may also increase the risk of side effects affecting urinary, bowel, and sexual function. For this reason, different radiation techniques have been developed to safely deliver higher doses while protecting surrounding healthy organs.\n\nSeveral approaches to radiation dose escalation are currently used in clinical practice. These include stereotactic body radiotherapy (SBRT), which delivers radiation in a small number of highly precise treatments, as well as brachytherapy, where radioactive sources are placed directly inside the prostate for a short time (high-dose-rate brachytherapy) or permanently (low-dose-rate brachytherapy). Although all these approaches are accepted and widely used, it is not known which strategy provides the best balance between cancer control, treatment-related side effects, and long-term quality of life, particularly when modern imaging techniques are used to accurately stage the disease.\n\nThe PRO-BOOST-LC study aims to directly compare different radiation dose escalation strategies using a standardized treatment framework. All participants enrolled in the study will have localized prostate cancer staged with PSMA PET imaging to exclude metastatic disease. Participants will then be randomly assigned to one of four treatment groups. One group will receive SBRT alone to the prostate. The other three groups will receive a short course of external beam radiotherapy followed by an additional focused radiation boost delivered using one of three methods: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or SBRT. All treatment approaches used in this study are established methods routinely applied in clinical practice.\n\nRandomization ensures that each participant has an equal chance of being assigned to any of the treatment groups. This allows the study to fairly compare outcomes between the different strategies. The main objective of the trial is to determine whether adding a radiation boost improves treatment outcomes compared with SBRT alone. The primary outcome measure is failure-free survival, which includes cancer recurrence, disease progression, the need for additional cancer treatment, or death from any cause. Secondary outcomes include the development of distant metastases, overall survival, treatment-related side effects, and patient-reported quality of life.\n\nParticipants will be closely monitored throughout the study. Before treatment, patients will undergo clinical evaluation, blood tests including prostate-specific antigen (PSA), imaging studies, and quality-of-life assessments. During and after treatment, participants will attend regular follow-up visits. These visits will include clinical examinations, PSA testing, assessment of treatment-related side effects, and completion of standardized questionnaires evaluating urinary, bowel, and sexual function, as well as overall quality of life. Imaging studies, including PSMA PET scans, will be performed when clinically indicated to assess for possible disease recurrence or progression.\n\nThe study is designed to follow participants for many years in order to capture both early and long-term outcomes. By using modern radiotherapy techniques, standardized treatment protocols, and comprehensive follow-up, PRO-BOOST-LC aims to generate high-quality evidence that will help guide future treatment decisions for patients with localized prostate cancer. The results of this trial are expected to improve understanding of how best to use radiation dose escalation to maximize cancer control while minimizing side effects and preserving quality of life in the era of advanced imaging and precision radiotherapy.\n\nParticipation in this study does not involve experimental or unproven treatments. All radiation techniques used in PRO-BOOST-LC are approved, widely available, and considered standard of care in many treatment centers worldwide. The study focuses on optimizing how these existing techniques are combined and delivered, rather than introducing new drugs or devices. Participation may involve additional follow-up assessments and questionnaires compared with routine care, but treatment decisions are made within established clinical practice guidelines. Patients may or may not directly benefit from participation, but the information gained from this study may help improve future treatment strategies for men with localized 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","2026-03-19",{"date":131,"type":132},"2026-03-23","ACTUAL",{"date":129,"type":132},{"date":135,"type":104},"2035-12",{"name":5,"class":6},1]