[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affidea Nu-med Center of Oncological DIagnostics and Therapy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":125},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100644252","reirradiation-and-total-ablative-strategies-for-recurrent-gynecologic-cancer-100644252",false,"NCT07667192","Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer","REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies","Regynera-RT","Inclusion Criteria:\n\n* \\- Age 18 years or older at the time of reirradiation or prospective enrollment.\n* Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.\n* Documented prior radiotherapy delivered as part of previous treatment.\n* Recurrent or progressive disease for which reirradiation and\u002For total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.\n* Recurrence or progression documented by imaging, clinical examination, pathology, and\u002For multidisciplinary tumor board assessment according to institutional practice.\n* Availability of minimum essential data, including prior radiotherapy information, date of reirradiation or planned reirradiation, disease extent at reirradiation, and at least one follow-up, outcome, or survival-status record for retrospective patients.\n* For prospective patients, written informed consent where required by local regulations and ethics approval.\n\nExclusion Criteria:\n\n* No evidence of prior radiotherapy.\n* No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.\n* Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival\u002Ffollow-up status.\n* Exclusively polymetastatic disease with more than 5 active non-regional lesions treated without a meaningful local reirradiation or total ablative component, unless included in an exploratory non-core substudy approved by the steering committee.\n* Prospective refusal of consent when consent is required by local law or ethics approval.","FEMALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","5 Years","OBSERVATIONAL","REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and\u002For total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.",[26,27,28,29,30,31,32,33],"Recurrent Gynecologic Cancer","Recurrent Uterine Cancer","Recurrent Cervical Cancer","Recurrent Vaginal Cancer","Recurrent Vulvar Cancer","Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Primary Peritoneal Cancer",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Reirradiation","Radiotherapy","Brachytherapy","External Beam Radiotherapy","Stereotactic Body Radiotherapy","Proton Therapy","Intraoperative Radiotherapy","Total Ablative Strategy","Oligometastatic Recurrence","Metastasis-Directed Therapy","Patient Registry","Radiographic Progression-Free Survival","Treatment-Related Adverse Events","Fistula","Overall survival","RECRUITING","2026-06-20",{"date":53,"type":54},"2026-06-24","ACTUAL",{"date":56,"type":54},"2026-06-11",{"date":58,"type":21},"2036-12",{"name":60,"class":61},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":62},"100625704","phase-2-pro-boost-n-prostate-first-versus-combined-prostate-and-nodal-dose-escalation-in-psma-pet-staged-node-positive-prostate-cancer-100625704","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",{"count":73,"type":21},1600,"INTERVENTIONAL",[76,77],"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.",[80,37,81,82,83],"Prostate Cancer","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors","Regionally Advanced Prostate Cancer",[36,39,85,37,86,87,88,89,90,91,92,93,94],"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":97,"type":54},"2026-03-23",{"date":95,"type":54},{"date":100,"type":21},"2035-12-01",{"name":60,"class":61},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":74,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":62},"100625701","phase-2-pro-boost-lc-whole-gland-boost-strategies-versus-sbrt-monotherapy-in-psma-staged-localized-and-locally-advanced-prostate-cancer-100625701","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.",{"count":111,"type":21},1200,[76,77],"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.",[115,116,81,82,117],"Prostate Cancer (Adenocarcinoma)","Prostate Brachytherapy","Localized Prostate Cancer",[36,39,85,37,86,87,88,89,90,91,92,119],"Failure-Free Survival",{"date":97,"type":54},{"date":95,"type":54},{"date":123,"type":21},"2035-12",{"name":60,"class":61},""]