Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

Overview

• 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. At 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.