{"entity":{"id":"nct00567580","kind":"trial","name":"Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer","aka":["SPPORT","NRG Oncology RTOG 0534"],"tldr":"A phase 3 trial of Flutamide, Bicalutamide, Goserelin / leuprolide, Buserelin and Triptorelin in Prostate cancer, run by Radiation Therapy Oncology Group, with a status the registry has not verified recently.","summary":"Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer is a phase 3 interventional study registered as NCT00567580 by Radiation Therapy Oncology Group, with 1792 participants planned, started 2008-02 and due to reach its primary completion in 2018-07-12. Interventions recorded: PBRT, PLNRT, AA, LHRH agonist. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Buserelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"positive","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00567580","url":"https://clinicaltrials.gov/study/NCT00567580"},{"label":"SPPORT / NRG Oncology RTOG 0534 (Lancet 2022)","url":"https://doi.org/10.1016/S0140-6736(21)01790-6"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":[],"targets":[],"drugs":["flutamide","bicalutamide","goserelin","buserelin","triptorelin"],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":["getug-afu-16","radicals-hd","rtog-9601"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["SPPORT was run at 283 radiation oncology centres in the United States, Canada and Israel between 31 March 2008 and 30 March 2015, enrolling men with a persistently detectable or initially undetectable and rising PSA of 0.1 to 2.0 ng/mL after prostatectomy, pT2 or pT3 disease and a Gleason score of 9 or less. Prostate bed radiotherapy was 64.8 to 70.2 Gy at 1.8 Gy per fraction; pelvic nodal radiotherapy was 45 Gy at 1.8 Gy per fraction before a volume reduction for the remaining 19.8 to 25.2 Gy. Of 1,792 enrolled men, 76 were later found ineligible, leaving 1,716 evaluable.\n\nAt the interim analysis of 1,191 men the Haybittle-Peto boundary of p<0.001 was exceeded comparing group 1 with group 3 (difference 17.9 percent, standard error 2.9, p<0.0001); the difference between groups 2 and 3 did not exceed the boundary (p=0.0063). Late toxicity beyond 3 months did not differ significantly between groups, apart from more late grade 2 or worse blood or bone marrow events in group 3 than group 2 (one-sided p=0.0060), attributable to the nodal radiotherapy (Lancet 2022)."],"nct":"NCT00567580","phase":"3","setting":"A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy","sponsor":"Radiation Therapy Oncology Group","result":"Five-year freedom from progression after prostatectomy 70.9 percent with prostate bed radiotherapy alone, 81.3 percent with added short-term androgen deprivation and 87.4 percent with pelvic nodal radiotherapy as well.","started":"2008-02","yearReported":2022,"enrolled":1792,"enrolledBasis":"registry","outcomes":[{"endpoint":"Freedom from progression at 5 years","primary":true,"unit":"%","arms":[{"name":"Prostate bed radiotherapy alone","n":592,"value":70.9,"note":"Analysed in 1,716 eligible men at a median 8.2 years among survivors; group 3 was superior to groups 1 and 2 per protocol."},{"name":"Prostate bed radiotherapy with short-term androgen deprivation","n":602,"value":81.3},{"name":"Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation","n":598,"value":87.4}],"source":"https://doi.org/10.1016/S0140-6736(21)01790-6"},{"endpoint":"Acute grade 2 or worse adverse events within 3 months","unit":"%","arms":[{"name":"Prostate bed radiotherapy alone","n":547,"value":18,"note":"Group 3 against group 2 p=0.0034; group 2 against group 1 p<0.0001."},{"name":"Prostate bed radiotherapy with short-term androgen deprivation","n":563,"value":36},{"name":"Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation","n":563,"value":44}],"source":"https://doi.org/10.1016/S0140-6736(21)01790-6"}],"replication":"GETUG-AFU 16 showed the androgen deprivation component independently, raising 120-month progression-free survival from 49 to 64 percent with 6 months of goserelin."},"route":"/trials/nct00567580/","neighbours":{"cancer":[{"id":"prostate-bcr","kind":"cancer","name":"Biochemical recurrence of prostate cancer","route":"/cancers/prostate-bcr/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"drug":[{"id":"bicalutamide","kind":"drug","name":"Bicalutamide","route":"/drugs/bicalutamide/"},{"id":"buserelin","kind":"drug","name":"Buserelin","route":"/drugs/buserelin/"},{"id":"flutamide","kind":"drug","name":"Flutamide","route":"/drugs/flutamide/"},{"id":"goserelin","kind":"drug","name":"Goserelin / leuprolide (ovarian function suppression)","route":"/drugs/goserelin/"},{"id":"triptorelin","kind":"drug","name":"Triptorelin","route":"/drugs/triptorelin/"}],"company":[{"id":"nrg-oncology","kind":"company","name":"NRG Oncology","route":"/companies/nrg-oncology/"}],"trial":[{"id":"getug-afu-16","kind":"trial","name":"GETUG-AFU 16","route":"/trials/getug-afu-16/"},{"id":"radicals-hd","kind":"trial","name":"RADICALS-HD","route":"/trials/radicals-hd/"},{"id":"rtog-9601","kind":"trial","name":"RTOG 9601","route":"/trials/rtog-9601/"}]}}