A study to investigate whether Budesonide suppositories are safe and contribute to the relief of radiation symptoms in men undergoing radiation therapy for prostate cancer
Summary description of the study
This is a prospective, double-blind, randomized, placebo-controlled, multicenter, two-arm Phase II clinical parallel group study to evaluate the efficacy and tolerability of a rectal treatment with Budesonide suppositories compared to placebo suppositories for the relief of radiation therapy (RT)-related symptoms in male patients aged 18 years or older with prostate cancer.
(BASEC)
Intervention under investigation
Budenofalk® 4 mg suppositories were approved by the European Medicines Agency (EMA) in 2023 for the treatment of acute ulcerative colitis (UC) limited to the rectum (ulcerative proctitis). There is a clear rationale to test Budesonide suppositories as an intervention for alleviating the symptoms of radiation proctitis, as radiation proctitis shares pathophysiological and symptomatic similarities with ulcerative colitis. Furthermore, the results of the initial proof-of-concept study BUF showed...
(BASEC)
Disease under investigation
Proctitis: Inflammation of the rectal wall
(BASEC)
- Male patients who are at least 18 years old at the time of signing the informed consent - Diagnosis of prostate cancer (primary or biochemical recurrence) - Local radiation therapy using external beam radiation therapy planned (BASEC)
Exclusion criteria
- Treatment with brachytherapy - Crohn's disease, unspecified colitis, ischemic colitis, ulcerative colitis, microscopic colitis (i.e., collagenous or lymphocytic colitis) - Internal hemorrhoids grade III (BASEC)
Trial sites
Basel, Chur
(BASEC)
Sponsor
DR. FALK PHARMA GMBH
(BASEC)
Contact
Contact Person Switzerland
Mrs. Claudia Stosnach
+49 0761 15140
Claudia.Stosnach@clutterdrfalkpharma.deDR. FALK PHARMA GMBH Leinenweberstraße 5 D-79108 Freiburg
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
18.12.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Protocol Full Title: A double-blind, randomized, placebo-controlled, two arm, phase II clinical trial in parallel groups to evaluate the efficacy and tolerability of a rectal treatment with budesonide suppositories compared to placebo suppositories for amelioration of acute radiation proctitis symptoms in male patients aged 18 years or older with prostate carcinoma. (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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