{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:49:40Z","timestamp":1792050580513,"version":"4.4.0"},"reference-count":39,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T00:00:00Z","timestamp":1694736000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Intraprostatic local radiorecurrence (LRR) after definitive radiation is being increasingly identified due to the implementation of molecular positron emission tomography (PET)\/computed tomography (CT) imaging for the evaluation of biochemical recurrence. Salvage high\u2010dose rate (HDR) brachytherapy offers a promising local therapy option, with encouraging toxicity and efficacy based on early series. Furthermore, the incorporation of advanced imaging allows for focal HDR to further reduce toxicity to maximise the therapeutic ratio. The objectives of the \u2018focal salvage HDR brachytherapy for locally recurrent prostate cancer in patients treated with prior radiotherapy\u2019 (F\u2010SHARP) trial are to determine the acute and late toxicity and efficacy outcomes of focal salvage HDR brachytherapy for LRR prostate cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design<\/jats:title>\n                    <jats:p>The F\u2010SHARP is a multi\u2010institutional two\u2010stage Phase I\/II clinical trial of salvage focal HDR brachytherapy for LRR prostate cancer enrolling patients at three centres.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Endpoints<\/jats:title>\n                    <jats:p>The primary endpoint is the acute radiation\u2010related Grade \u22653 Common Terminology Criteria for Adverse Events (CTCAE, version 4.03) genitourinary (GU) and gastrointestinal (GI) toxicity rate, defined as within 3\u2009months of brachytherapy. Secondary endpoints include acute and late CTCAE toxicity, biochemical failure, patterns of clinical progression, disease\u2010specific and overall survival, and health\u2010related quality of life, as measured by the International Prostate Symptom Score and 26\u2010item Expanded Prostate Cancer Index Composite instruments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>Key eligibility criteria include: biopsy confirmed LRR prostate adenocarcinoma after prior definitive radiation therapy using any radiotherapeutic modality, no evidence of regional or distant metastasis, and cT1\u20133a Nx or N0 prostate cancer at initial treatment. All patients will have multiparametric magnetic resonance imaging and molecular PET\/CT imaging if possible. In Stage 1, seven patients will be accrued. If there are two or more GI or GU Grade \u22653 toxicities, the study will be stopped. Otherwise, 17 additional patients will be accrued (total of 24 patients). For Stage 2, the cohort will expand to 62 subjects to study the efficacy outcomes, long\u2010term toxicity profile, quality of life, and compare single\u2010 vs multi\u2010fraction HDR. Transcriptomic analysis of recurrence biopsies will be performed to identify potential prognostic and predictive biomarkers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.16150","type":"journal-article","created":{"date-parts":[[2023,8,10]],"date-time":"2023-08-10T20:33:15Z","timestamp":1691699595000},"page":"188-196","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["F\u2010SHARP: a Phase I\/II trial of focal salvage high\u2010dose\u2010rate brachytherapy for Radiorecurrent prostate cancer"],"prefix":"10.1111","volume":"133","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-2186-2987","authenticated-orcid":false,"given":"Abhishek A.","family":"Solanki","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology, Stritch School of Medicine Cardinal Bernardin Cancer Center, Loyola University Chicago  Maywood IL USA"},{"name":"Department of Radiation Oncology Loyola University Medical Center  Maywood IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan K.","family":"Yoo","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Stritch School of Medicine Cardinal Bernardin Cancer Center, Loyola University Chicago  Maywood IL USA"},{"name":"Department of Radiation Oncology Loyola University Medical Center  Maywood IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Adams","sequence":"additional","affiliation":[{"name":"Department of Medicine, Stritch School of Medicine Loyola University Chicago, Loyola University Medical Center  Maywood IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elai","family":"Davicioni","sequence":"additional","affiliation":[{"name":"Veracyte, Inc.  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