{"entity":{"id":"raves","kind":"trial","name":"RAVES (TROG 08.03/ANZUP)","aka":["RAVES","TROG 08.03","ANZUP RAVES"],"tldr":"Waiting for the PSA to rise before giving radiotherapy after prostate surgery gave the same cancer control and spared half the men pelvic radiation, though the trial closed too early to prove it formally.","summary":"RAVES randomised 333 men across 32 oncology centres in Australia and New Zealand, 166 to adjuvant radiotherapy within 6 months of prostatectomy and 167 to early salvage radiotherapy triggered by a PSA of 0.20 ng/mL or more. Radiotherapy in both arms was 64 Gy in 32 fractions to the prostate bed without androgen deprivation, with real-time review of plan quality before treatment.\n\nAn independent data monitoring committee recommended premature closure of enrolment because event rates were unexpectedly low. At a median 6.1 years, 84 of 167 men (50 percent) in the salvage group had been triggered to treatment. Five-year freedom from biochemical progression was 86 percent (95 percent confidence interval 81 to 92) with adjuvant radiotherapy and 87 percent (82 to 93) with salvage, stratified hazard ratio 1.12 (0.65 to 1.90). Non-inferiority, which required the upper bound to stay under 1.48, was not formally met (p=0.15).\n\nToxicity separated cleanly. Grade 2 or worse genitourinary toxicity occurred in 90 of 167 men (54 percent) in the salvage group against 116 of 166 (70 percent) in the adjuvant group. Gastrointestinal toxicity was similar (10 against 14 percent). The authors concluded that the data support salvage radiotherapy despite the formal failure, because it gives similar biochemical control, spares about half of men pelvic radiation and causes significantly less genitourinary toxicity.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00860652","url":"https://clinicaltrials.gov/study/NCT00860652"},{"label":"RAVES (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30456-3"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["anzup"],"institutions":[],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","neoadjuvant-adjuvant"],"trials":["radicals-rt","getug-afu-17","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00860652","phase":"3","setting":"Prostate cancer after radical prostatectomy with positive margins, extraprostatic extension or seminal vesicle invasion and a postoperative PSA of 0.10 or less: adjuvant radiotherapy of 64 Gy in 32 fractions within 6 months against early salvage radiotherapy triggered by a PSA of 0.20 or more, without androgen deprivation, with freedom from biochemical progression as the primary endpoint and a non-inferiority design","sponsor":"Trans-Tasman Radiation Oncology Group and ANZUP Cancer Trials Group","result":"Five-year freedom from biochemical progression 87 percent with early salvage against 86 percent with adjuvant radiotherapy (hazard ratio 1.12, 95 percent confidence interval 0.65 to 1.90); formal non-inferiority not met (p=0.15), but grade 2 or worse genitourinary toxicity 54 against 70 percent.","yearReported":2020,"enrolled":333,"enrolledBasis":"randomised","enrolledNote":"333 men were randomised before an independent data monitoring committee recommended premature closure of enrolment because event rates were unexpectedly low.","outcomes":[{"endpoint":"Freedom from biochemical progression at 5 years","primary":true,"unit":"%","arms":[{"name":"Early salvage radiotherapy","n":167,"value":87},{"name":"Adjuvant radiotherapy","n":166,"value":86}],"hr":1.12,"ci":[0.65,1.9],"p":"0.15 for non-inferiority","source":"https://doi.org/10.1016/S1470-2045(20)30456-3"},{"endpoint":"Grade 2 or worse genitourinary toxicity","unit":"%","arms":[{"name":"Early salvage radiotherapy","n":167,"value":54},{"name":"Adjuvant radiotherapy","n":166,"value":70}],"source":"https://doi.org/10.1016/S1470-2045(20)30456-3"}],"replication":"RADICALS-RT and GETUG-AFU 17 found the same, and the ARTISTIC meta-analysis pooled all three."},"route":"/trials/raves/","neighbours":{"cancer":[{"id":"prostate-bcr","kind":"cancer","name":"Biochemical recurrence of prostate cancer","route":"/cancers/prostate-bcr/"},{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"company":[{"id":"anzup","kind":"company","name":"ANZUP Cancer Trials Group","route":"/companies/anzup/"}],"term":[{"id":"biochemical-recurrence","kind":"term","name":"Biochemical recurrence (BCR)","route":"/terms/biochemical-recurrence/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"}],"trial":[{"id":"artistic-meta-analysis","kind":"trial","name":"ARTISTIC meta-analysis","route":"/trials/artistic-meta-analysis/"},{"id":"getug-afu-17","kind":"trial","name":"GETUG-AFU 17","route":"/trials/getug-afu-17/"},{"id":"radicals-rt","kind":"trial","name":"RADICALS-RT","route":"/trials/radicals-rt/"}]}}