{"entity":{"id":"nct00002633","kind":"trial","name":"Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer","aka":["NCIC CTG PR.3","MRC PR07","Intergroup T94-0110"],"tldr":"A phase 3 trial of Bicalutamide, Buserelin, Flutamide, Goserelin / leuprolide, Leuprolide and Nilutamide in Prostate cancer, run by NCIC Clinical Trials Group, completed.","summary":"Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00002633 by NCIC Clinical Trials Group, with 361 participants recorded, started 1995-02-08 and reaching its primary completion in 2011-09-23. Interventions recorded: bicalutamide, buserelin, flutamide, goserelin, leuprolide acetate, nilutamide, orchiectomy, radiation therapy. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Nilutamide 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":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00002633","url":"https://clinicaltrials.gov/study/NCT00002633"},{"label":"NCIC CTG PR.3 / MRC PR07 final report (Journal of Clinical Oncology 2015)","url":"https://doi.org/10.1200/JCO.2014.57.7510"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["bicalutamide","buserelin","flutamide","goserelin","leuprolide","nilutamide"],"companies":["cctg"],"institutions":[],"pathways":[],"terms":[],"trials":["spcg-7","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["The trial, registered as NCT00002633 and known as NCIC Clinical Trials Group PR.3, Medical Research Council PR07 and Intergroup T94-0110, randomised 1,205 men between 1995 and 2005 with T3 to T4 N0 or Nx M0 prostate cancer, or T1 to T2 disease with a PSA above 40 micrograms per litre, or a PSA of 20 to 40 with a Gleason score of 8 to 10. Randomisation was to lifelong androgen deprivation alone or androgen deprivation with radiotherapy of 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or to the prostate alone.\n\nAt a median 8 years, 465 men had died, 199 of prostate cancer. Overall survival was significantly better with the addition of radiotherapy (hazard ratio 0.70, 95 percent confidence interval 0.57 to 0.85, p<0.001) and deaths from prostate cancer were significantly reduced (0.46, 0.34 to 0.61, p<0.001). Men on the combination reported more bowel toxicity, but only two of 589 had grade 3 or greater diarrhoea at 24 months after radiotherapy (Journal of Clinical Oncology 2015).","The registry record gives 361 participants, which is the figure recorded on ClinicalTrials.gov; the published intergroup analysis reports 1,205 randomised. The published figure is the one used above."],"nct":"NCT00002633","phase":"3","setting":"Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation in Clinical Stage T3-4, N0, M0 Adenocarcinoma of the Prostate","sponsor":"NCIC Clinical Trials Group","result":"Adding radiotherapy to lifelong androgen deprivation in locally advanced prostate cancer improved overall survival (hazard ratio 0.70, 95 percent confidence interval 0.57 to 0.85, p<0.001) and halved deaths from prostate cancer (0.46, 0.34 to 0.61, p<0.001) at a median 8 years.","started":"1995-02-08","startedType":"actual","yearReported":2015,"enrolled":361,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Androgen deprivation with radiotherapy","n":603},{"name":"Androgen deprivation alone","n":602}],"hr":0.7,"ci":[0.57,0.85],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2014.57.7510"},{"endpoint":"Death from prostate cancer","arms":[{"name":"Androgen deprivation with radiotherapy","n":603},{"name":"Androgen deprivation alone","n":602}],"hr":0.46,"ci":[0.34,0.61],"p":"<0.001","source":"https://doi.org/10.1200/JCO.2014.57.7510"}],"replication":"SPCG-7 found the same in 875 men, halving 10-year prostate cancer mortality from 23.9 to 11.9 percent."},"route":"/trials/nct00002633/","neighbours":{"cancer":[{"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/"}],"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":"leuprolide","kind":"drug","name":"Leuprolide (leuprorelin) and GnRH agonists","route":"/drugs/leuprolide/"},{"id":"nilutamide","kind":"drug","name":"Nilutamide","route":"/drugs/nilutamide/"}],"company":[{"id":"cctg","kind":"company","name":"Canadian Cancer Trials Group (CCTG)","route":"/companies/cctg/"}],"trial":[{"id":"eortc-22863","kind":"trial","name":"EORTC 22863","route":"/trials/eortc-22863/"},{"id":"spcg-7","kind":"trial","name":"SPCG-7/SFUO-3","route":"/trials/spcg-7/"}]}}