#1 Clinical Trials Search in Europe

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

2 1 1

What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany

Other Sites

Site Name City Country Status
Landeskrankenhaus Salzburg Graz Austria
Krankenhaus Der Barmherzigen Schwestern Wien Betriebsgesellschaft mbH Vienna Austria
Kjxkzscp Krjawyrzjo ap Wvqcjhypoi Klagenfurt am Wörthersee Austria
Lerqvgnodrdtckkqe Sokxwyxi Salzburg Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.01.2026
Germany Germany
Recruiting
01.01.2026

Trial locations

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.

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 ID:
2024-519359-27-00
Protocol code:
BUS-006/RAP
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Adjuvant mRNA-4157 and pembrolizumab for patients with completely resected high‑risk stage I non‑small cell lung cancer

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Hungary Italy The Netherlands +2

  • Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

    Recruiting

    2 1 1 1
    Investigated diseases:
    Czechia Denmark France Germany Hungary Ireland +4