{"preliminary_commentary":{"by_channel":{"x_thread":3,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[],"indication":"intermediate-risk prostate cancer","name":"PROSINT","nct_id":"NCT02570919","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=prosint-nct02570919. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PROSINT","arms":[{"description":"Arm A: Hypofractionated IGRT at a prescription dose of 45 Gy in 5 fractions of 9 Gy delivered in five consecutive days","label":"IGRT 45 Gy in 5 fractions of 9 Gy","type":"ACTIVE_COMPARATOR"},{"description":"Arm B: single fraction IGRT at a prescription dose of 24 Gy","label":"IGRT 24 Gy single dose","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2017-12-31","type":"ACTUAL"},"conditions":["PROSTATE CANCER"],"enrollment":{"count":30,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"IGRT 45 Gy in 5 fractions of 9 Gy","otherNames":[],"type":"RADIATION"},{"name":"IGRT 24 Gy single dose","otherNames":[],"type":"RADIATION"}],"last_update":"2019-07-23","lead_sponsor":"Fundacao Champalimaud","official_title":"Phase II Randomized Study Comparing Ultra-high-dose Hypofractionated vs. Single-dose Image-Guided Radiotherapy (IGRT) With Urethral Sparing for Intermediate Risk Prostate Cancer","overall_status":"COMPLETED","phases":["NA"],"primary_completion_date":{"date":"2017-09-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0","timeFrame":"Participants should be followed continuously, for the duration of 5 years"}],"references":[{"citation":"Greco C, Pares O, Pimentel N, Louro V, Santiago I, Vieira S, Stroom J, Mateus D, Soares A, Marques J, Freitas E, Coelho G, Seixas M, Lopez-Beltran A, Fuks Z. Safety and Efficacy of Virtual Prostatectomy With Single-Dose Radiotherapy in Patients With Intermediate-Risk Prostate Cancer: Results From the PROSINT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):700-708. doi: 10.1001/jamaoncol.2021.0039.","pmid":"33704378","type":"DERIVED"},{"citation":"Bodo S, Campagne C, Thin TH, Higginson DS, Vargas HA, Hua G, Fuller JD, Ackerstaff E, Russell J, Zhang Z, Klingler S, Cho H, Kaag MG, Mazaheri Y, Rimner A, Manova-Todorova K, Epel B, Zatcky J, Cleary CR, Rao SS, Yamada Y, Zelefsky MJ, Halpern HJ, Koutcher JA, Cordon-Cardo C, Greco C, Haimovitz-Friedman A, Sala E, Powell SN, Kolesnick R, Fuks Z. Single-dose radiotherapy disables tumor cell homologous recombination via ischemia/reperfusion injury. J Clin Invest. 2019 Feb 1;129(2):786-801. doi: 10.1172/JCI97631. Epub 2019 Jan 14.","pmid":"30480549","type":"DERIVED"}],"start_date":{"date":"2015-09-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase II Study of Ultra-high-dose Hypofractionated vs. Single-dose Image-Guided Radiotherapy for Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT02570919"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/prosint-nct02570919"}