Budesonide Foam Versus Placebo for Prevention of Acute Radiation Proctitis

Randomised, Double-blind, Placebo-controlled, Multicentre, Comparative Phase II Pilot Study on the Efficacy and Tolerability of an 8-week Rectal Treatment With 2 mg Budesonide or Placebo for the Prevention of Acute Radiation Proctitis

To proof the superiority of an 8-week rectal treatment with once-daily 2 mg budesonide versus placebo for the prevention of acute radiation proctitis, and to evaluate the occurrence of chronic radiation proctitis 1 year after start of radiation therapy.

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