{"id":940,"date":"2023-07-19T15:27:21","date_gmt":"2023-07-19T13:27:21","guid":{"rendered":"https:\/\/www.degro.org\/ag-stereotaxie\/?page_id=940"},"modified":"2023-07-19T16:40:57","modified_gmt":"2023-07-19T14:40:57","slug":"hypofocal","status":"publish","type":"page","link":"https:\/\/www.degro.org\/ag-stereotaxie\/projekte\/aktuelle-projekte\/hypofocal\/","title":{"rendered":"HypoFocal Trial"},"content":{"rendered":"<div id=\"pl-940\"><style scoped>#pg-940-0 .panel-grid-cell { float:none } #pl-940 .panel-grid-cell .so-panel { margin-bottom:30px } #pl-940 .panel-grid-cell .so-panel:last-child { margin-bottom:0px } #pg-940-0 { margin-left:-15px;margin-right:-15px } #pg-940-0 .panel-grid-cell { padding-left:15px;padding-right:15px } @media (max-width:780px){ #pg-940-0 .panel-grid-cell { float:none;width:auto } #pl-940 .panel-grid , #pl-940 .panel-grid-cell {  } #pl-940 .panel-grid .panel-grid-cell-empty { display:none } #pl-940 .panel-grid .panel-grid-cell-mobile-last { margin-bottom:0px }  } <\/style><div class=\"panel-grid\" id=\"pg-940-0\" ><div class=\"panel-grid-cell\" id=\"pgc-940-0-0\" ><div class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" id=\"panel-940-0-0-0\" data-index=\"0\"><div class=\"so-widget-sow-editor so-widget-sow-editor-base\">\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<h2>PSMA-PET\/MRI-Based Focal Dose Escalation in Patients with Primary Prostate Cancer Treated with Stereotactic Body Radiation Therapy (HypoFocal-SBRT)<\/h2>\n<hr \/>\n<p><strong>Study PIs:<\/strong><\/p>\n<p>Prof. Dr. Anca-L. Grosu (Freiburg)<br \/>\nPD Dr. Constantinos Zamboglou (Freiburg)<br \/>\nDr. med. Simon Spohn (Freiburg)<br \/>\nProf. Dimos Baltas (Freiburg)<\/p>\n<p><strong>Contact: <\/strong><a href=\"mailto:anca.grosu@uniklinik-freiburg.de\">anca.grosu@uniklinik-freiburg.de<\/a><\/p>\n<p><strong>Status:<br \/>\n<\/strong>\u25cf Recruiting centers<\/p>\n<p><strong>Study design:<br \/>\n<\/strong>\u25cf Multi-center, international, randomized, prospective, interventional 2-arm phase II study<\/p>\n<p><strong>Inclusion Criteria:<br \/>\n<\/strong><strong>\u25cf <\/strong>Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)<br \/>\n<strong>\u25cf <\/strong>Primary localized PCa (cN0 and cM0 in mpMRI and PSMA-PET): high- or very high-risk according to NCCN v2.2021 OR unfavorable intermediate-risk disease according to NCCN v2.2021<br \/>\n\u25cf Signed written informed consent for this study<br \/>\n\u25cf Age &gt; 18 years<br \/>\n\u25cf Previously conducted PSMA-PET\/CT and mpMRI scans or PSMA-PET\/MR for staging, fulfilling standard requirements for PCa<br \/>\n\u25cf ECOG performance score 0 or 1<br \/>\n\u25cf IPSS score \u2264 15<br \/>\n\u25cf Prostate volume \u2264 75 mL at RT planning<\/p>\n<p><strong>Exclusion criteria:<br \/>\n<\/strong>\u25cf Evidence of neuroendocrine tumor cells<br \/>\n\u25cf Prior radiotherapy to the prostate or pelvis<br \/>\n\u25cf Prior radical prostatectomy<br \/>\n\u25cf Prior focal therapy approaches to the prostate<br \/>\n\u25cf Time gap between the beginning of ADT and conduction of initial mpMRI and PSMA-PET scans is &gt;1 month<br \/>\n\u25cf Radiologically suspicious or pathologically confirmed lymph node involvement (cN+) in mpMRI and\/or PSMA-PET\/CT<br \/>\n\u25cf Evidence of metastatic disease (cM+) in mpMRI and\/or PSMA-PET\/CT<br \/>\n\u25cf Evidence of cT4 disease in mpMRI and\/or PSMA-PET\/CT<br \/>\n\u25cf PSA &gt; 30 ng\/mL prior to starting ADT<br \/>\n\u25cf Expected patient survival &lt;5 years<br \/>\n\u25cf Bilateral hip prostheses or any other implants\/hardware that would introduce substantial CT artefacts<br \/>\n\u25cf Contraindication to undergo a mpMRI scan<br \/>\n\u25cf Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization<br \/>\n\u25cf Medical conditions likely to make radiotherapy inadvisable, e.g., acute inflammatory bowel disease, hemiplegia or paraplegia<br \/>\n\u25cf Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival<br \/>\n\u25cf Any other contraindication to external beam radiotherapy (EBRT) to the pelvis<br \/>\n\u25cf In mpMRI and PSMA-PET\/CT or PSMA-PET\/MRI scans, no visible tumor<br \/>\n\u25cf Participation in any other interventional clinical trial within the last 30 days before the start of this trial<br \/>\n\u25cf Simultaneous participation in other interventional trials that could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed<br \/>\n\u25cf Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial<br \/>\n\u25cf Known or persistent abuse of medication, drugs or alcohol<br \/>\n\u25cf Patients expected to have severe set up problems<br \/>\n\u25cf Dose constraints for organs at risk cannot be adhered to<\/p>\n<p><strong>Sample size:<\/strong><br \/>\n\u25cf 374 patients with unfavorable intermediate- \/ High-Risk prostate cancer staged cN0 und cM0 in PSMA-PET\/CT and MRI recruiting at 22 centers in Germany, Switzerland, Austria and Cyprus<\/p>\n<p><strong>Endpoints:<\/strong><br \/>\n\u25cf Primary endpoint: relapse free survival (RFS)<br \/>\n\u25cf Secondary endpoint: time to local failure, metastatic free survival, overall (OS), prostate cancer specific survival (PCSS) and time to biochemical failure<br \/>\n\u25cf additional research: patient-reported outcomes, feasibility and adherence to dose constraints<\/p>\n<p><strong>Trial Registration<br \/>\n<\/strong>DRKS00022915<\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>#pg-940-0 .panel-grid-cell { float:none } #pl-940 .panel-grid-cell .so-panel { margin-bottom:30px } #pl-940 .panel-grid-cell .so-panel:last-child { margin-bottom:0px } #pg-940-0 { margin-left:-15px;margin-right:-15px } #pg-940-0 .panel-grid-cell { padding-left:15px;padding-right:15px } @media (max-width:780px){ #pg-940-0 .panel-grid-cell { float:none;width:auto } #pl-940 .panel-grid , #pl-940 .panel-grid-cell {  <\/p>\n","protected":false},"author":8,"featured_media":0,"parent":77,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/pages\/940"}],"collection":[{"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/comments?post=940"}],"version-history":[{"count":3,"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/pages\/940\/revisions"}],"predecessor-version":[{"id":954,"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/pages\/940\/revisions\/954"}],"up":[{"embeddable":true,"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/pages\/77"}],"wp:attachment":[{"href":"https:\/\/www.degro.org\/ag-stereotaxie\/wp-json\/wp\/v2\/media?parent=940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}