{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T16:59:30Z","timestamp":1761757170062,"version":"build-2065373602"},"reference-count":36,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T00:00:00Z","timestamp":1733702400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To investigate the safety and cancer control of a novel bioabsorbable, low\u2010dose rate brachytherapy device, CivaSheet\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (CivaTech Oncology Inc., Durham, NC, USA), in combination with radical prostatectomy (RP) with or without adjuvant external beam radiation therapy (EBRT) for the management of prostate cancer (PCa).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>This is an initial, single\u2010centre experience, two\u2010dose level, two\u2010stage study conducted on patients with intermediate\u2010 and high\u2010risk PCa. The CivaSheet was implanted during RP, followed by adjuvant EBRT in patients with adverse pathological features. Toxicities and peri\u2010 and postoperative complications were assessed. Biochemical recurrence (BCR) at the 6\u2010month follow\u2010up after EBRT was also evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Six patients were enrolled, with a median (range) age of 56\u2009(53\u201371)\u2009years. No intraoperative complications occurred. No dose\u2010limiting toxicities were observed at a maximum tested dose of 75\u2009Gy. BCR occurred in one patient at 6\u2009months, while another patient had residual disease and metastasis at 6\u2009months. All patients reported having postoperative erectile dysfunction and one patient experienced urinary incontinence after EBRT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study demonstrated the feasibility and safety of CivaSheet combined with RP and adjuvant EBRT for high\u2010risk PCa. The short\u2010term toxicity profile was well\u2010tolerated, supporting further prospective evaluation with clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.16617","type":"journal-article","created":{"date-parts":[[2024,12,10]],"date-time":"2024-12-10T02:39:11Z","timestamp":1733798351000},"page":"782-791","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Novel bioabsorbable, low\u2010dose rate brachytherapy device\n                    <scp>(CivaSheet<\/scp>\n                    <sup>\u00ae<\/sup>\n                    ) with radical prostatectomy and adjuvant external beam radiation for the management of prostate cancer"],"prefix":"10.1111","volume":"135","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7165-0823","authenticated-orcid":false,"given":"Kennedy E.","family":"Okhawere","sequence":"first","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shirin","family":"Razdan","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alp Tuna","family":"Beksac","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"},{"name":"Glickman Urological and Kidney Institute Cleveland Clinic  Cleveland OH USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Indu","family":"Saini","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2612-6950","authenticated-orcid":false,"given":"Laura","family":"Zuluaga","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirolos","family":"Meilika","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Burak","family":"Ucpinar","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ren\u2010Dih","family":"Sheu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reza","family":"Mehrazin","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Sfakianos","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashutosh","family":"Tewari","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard G.","family":"Stock","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5472-7294","authenticated-orcid":false,"given":"Ketan","family":"Badani","sequence":"additional","affiliation":[{"name":"Department of Urology Icahn School of Medicine at Mount Sinai  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,12,9]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21731"},{"key":"e_1_2_12_3_1","unstructured":"American Cancer Society.What Are the Survival Rates for Prostate Cancer?2024. 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