Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of budesonide suppositories to treat acute radiation proctitis in men with prostate cancer

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with prostate carcinoma, which is a type of cancer affecting the prostate gland. Some of these individuals may experience acute radiation proctitis, a condition involving inflammation of the rectum caused by radiation therapy. This inflammation can lead to symptoms such as rectal pain, diarrhea, and bleeding.

The purpose of the study is to evaluate how well a rectal treatment works for these symptoms. Participants will be assigned to receive either budesonide, which is a type of steroid medication, or a placebo. Both medications will be administered as a suppository, which is a small, solid medicated piece inserted into the rectum for absorption. The study will take place over eight weeks, with the medication used once every day.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment phase</b>

    A treatment period lasting 8 weeks is initiated.

    One suppository is administered once daily via rectal use.

    The medication provided is either budenofalk, containing 4 mg of budesonide, or a placebo, which is an inactive substance used for comparison.

    During this time, symptoms of acute radiation proctitis, which is inflammation of the rectal lining caused by radiation, are monitored.

  2. Step 2

    <b>follow-up and evaluation</b>

    Assessments are conducted at specific intervals, labeled as visit 2, visit 4, and visit 5.

    The effectiveness of the treatment is evaluated by measuring changes in symptoms such as diarrhea, rectal pain, fecal incontinence (difficulty controlling bowel movements), lower gastrointestinal hemorrhage (bleeding in the digestive tract), and gastrointestinal pain.

    The tolerability of the medication is assessed by recording the frequency of bowel movements, the intensity of pain during bowel movements, and the presence of bloody or mucous stool.

    The impact on daily life is evaluated, including how symptoms affect daily functioning and the need for medical intervention.

Who can join the trial?

8 criteria

  • You must be a male patient (the sex assigned at birth) who is at least 18 years old at the time you agree to join the study.
  • You must have been diagnosed with prostate carcinoma, which is a type of cancer that starts in the prostate gland, or have signs that the cancer has returned through blood tests.
  • Your performance status, which is a scale used to measure how well you can carry out daily activities, must be ECOG 2 or lower or a Karnofsky score of 70% or higher.
  • You must be scheduled to receive external beam radiation therapy, which is a treatment that uses high-energy beams to target and kill cancer cells.
  • The radiation treatment must involve a total dose of 60-80 Gy (a unit used to measure radiation) delivered in 20-40 sessions over a period of 4 to 8 weeks.
  • You must have signed an informed consent form, which is a document where you agree to participate after understanding all the study details.
  • You must have experienced proctitis (inflammation of the lining of the rectum) or diarrhea at a level of grade 1 or higher for at least 3 days.
  • You must be able to use ePRO, which stands for electronic Patient-Reported Outcomes, meaning you must be able to enter your health information into a digital device at least 3 times per week.

Who cannot join the trial?

24 criteria

  • You have undergone brachytherapy, which is a type of radiation treatment where radioactive material is placed inside your body.
  • You are currently taking systemic or topical corticosteroids (medicines that reduce inflammation), immunosuppressants (drugs that lower your immune system's ability to fight infection), or medications that affect peristalsis (the wave-like muscle movements that push food through your gut) or the intestinal mucosa (the inner lining of your intestines), such as antibiotics, loperamide (used for diarrhea), opioids (strong pain medicines), or laxatives.
  • You are participating in another clinical study and have taken an investigational medicinal product (a drug being tested in a study) within the last 30 days or within a specific timeframe based on how long the drug stays in your system.
  • You have inflammatory bowel diseases such as Crohn’s disease, indeterminate colitis, ischemic colitis (reduced blood flow to the colon), ulcerative colitis, or microscopic colitis (inflammation visible only under a microscope).
  • You have Grade III internal hemorrhoids, which are enlarged blood vessels inside the rectum that may protrude.
  • You have perianal dermatitis, which is skin irritation or inflammation around the anus.
  • You have a significant infection in your gut caused by bacteria, amoebas (tiny single-celled organisms), fungi, or viruses.
  • You have a history of radiation therapy (RT) in your pelvic or lower abdominal area.
  • You have or have had colorectal cancer (cancer of the large intestine or rectum).
  • You have an active cancer other than prostate cancer, or have used antineoplastic drugs (cancer-fighting medicines) in the last 5 years, unless you have been cancer-free for at least 5 years.
  • You have phenylketonuria, which is a rare genetic condition where the body cannot break down a specific amino acid.
  • You have severe renal impairment, meaning your kidneys are not working well, measured by a GFR (glomerular filtration rate) of 29 ml/min or less.
  • You have a known intolerance, hypersensitivity (allergic reaction), or resistance to the study drug or its ingredients.
  • You are unlikely to follow the study rules due to reasons such as not having a permanent address, a history of drug abuse, or an unstable psychiatric history (mental health history).
  • You are unable to understand the details and impact of the study due to legal incapacity.
  • You are currently in custody or living in an institution due to a legal or regulatory order.
  • You are a staff member or a close relative of the staff involved in the study.
  • Your morning serum cortisol levels (a hormone produced by the adrenal glands) are less than 4 µg/dL.
  • You have active infections, uncontrolled hypertension (high blood pressure), diabetes mellitus (high blood sugar), an active peptic ulcer (sore in the stomach or intestine), osteoporosis (weak bones), glaucoma (eye pressure issues), or cataracts (clouding of the eye lens) that could be made worse by steroid use.
  • You are immunocompromised, meaning your immune system is weakened, for example due to HIV.
  • You have had chickenpox, herpes zoster (shingles), or measles within the last 3 months.
  • You have portal hypertension (high blood pressure in the vein leading to the liver) or liver cirrhosis (scarring of the liver).
  • You have abnormal hepatic parameters, which means your liver function tests (ALT, AST, or AP) are significantly higher than normal, or you have a liver disorder.
  • You have received a live vaccine within the last 14 days.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Budesonide is a medication used as a rectal suppository to help reduce inflammation and improve symptoms in the lining of the rectum caused by radiation therapy.

What is already known about the treatment

  • Budenofalk

    This medication is a suppository used for rectal application to treat inflammation in the rectum. It belongs to a group of medicines called corticosteroids and is used to reduce swelling and irritation in the digestive tract. At a molecular level, it works by blocking certain substances in the body that trigger the inflammatory response. This treatment is commonly used to manage symptoms related to inflammation of the rectal lining.

  • Placebo to test

    This is an inactive substance administered as a suppository through the rectum to serve as a comparison in the clinical study. It contains no active medicinal ingredients and is used to help researchers determine if the actual medication produces a real effect. It is classified as a control substance rather than a therapeutic medication.

Investigated diseases

Acute radiation proctitis - This condition involves inflammation of the lining of the rectum caused by exposure to radiation therapy. It often develops in the weeks or months following treatment. The condition can lead to symptoms such as rectal pain, frequent bowel movements, and bleeding. As it progresses, individuals may experience increased discomfort during bowel movements or changes in stool consistency. In some cases, it can cause difficulty controlling bowel movements.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519359-27-00Protocol codeBUS-006/RAPEstimated enrolment400 patientsSponsorDr. Falk Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.