Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Inclusion Criteria: * Signed informed consent, * Men aged at least 18 years, * Patients with ECOG performance status \<= 2 or Karnofsky Performance Status Scale \>= 70%, * Estimated life expectancy more than 3 years, * Diagnosis of prostate carcinoma, * Indication for local RT in patients with prostatic cancer. Exclusion Criteria: * Crohn's disease, indeterminate colitis, ulcerative colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), * Severe or symptomatic ischaemic colitis at baseline, * Grade III internal haemorrhoids at baseline, * High risk patients needing extended radiation therapy, * Acute EORTC/RTOG lower GI toxicity score of \>=1 at baseline, * Bacterial, amoebic, fungal, or viral infections of the gut, * Tuberculosis, hypertension, infection, diabetes mellitus (included familiarly predisposition), active peptic ulcer, osteoporosis, glaucoma, or cataract, if careful medical monitoring is not ensured, * Portal hypertension or liver cirrhosis, * Abnormal hepatic function (ALT, AST or AP \> 2.5 x ULN), * Known intolerance/hypersensitivity/resistance to study drug or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the study drug, * Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial