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Study on Darolutamide with Radiation Therapy for Patients with Intermediate Unfavorable Risk Prostate Cancer

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What is this study about?

This clinical trial is focused on studying prostate cancer, specifically in patients with an intermediate unfavorable risk. The trial will explore the effects of a treatment involving darolutamide, also known by its code name ODM-201, in combination with radiation therapy. The purpose of the study is to assess the preliminary signs of antitumor activity of darolutamide when used alongside radiation therapy.

Participants in the study will receive the treatment for a period of six months. The study will monitor the biological response to the treatment, particularly looking at the levels of PSA (Prostate-Specific Antigen), a protein produced by both normal and cancerous prostate cells. A successful response is defined as a PSA level of 0.1 ng/ml or lower, measured six months after starting the treatment. The study will also track other outcomes such as the time it takes for testosterone levels to recover after treatment and the overall safety profile of the treatment strategy.

Throughout the study, various assessments will be conducted, including quality of life evaluations and monitoring of potential side effects. The study will also include additional analyses, such as examining MRI images to predict treatment efficacy and collecting tumor samples to assess their prognostic value. The trial aims to provide valuable insights into the effectiveness of combining darolutamide with radiation therapy for treating prostate cancer with intermediate unfavorable risk.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. Consent is required before any study-specific activities begin.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary imaging tests such as MRI and CT scans.

3 treatment initiation

The treatment phase begins with the administration of darolutamide (ODM-201). This medication is taken orally, and the dosage is determined by the study protocol.

Concurrently, radiation therapy is administered as part of the treatment plan.

4 treatment duration

The treatment with darolutamide is scheduled for a duration of 6 months. During this period, regular monitoring and assessments are conducted to evaluate the treatment’s effectiveness and any side effects.

5 follow-up assessments

After the treatment phase, follow-up assessments are conducted to measure the biological response. This includes checking the PSA levels to ensure they are at or below 0.1 ng/ml, as well as other health evaluations.

6 long-term monitoring

Long-term monitoring is planned to assess the patient’s health status and any potential recurrence of the disease. This includes periodic evaluations over several years.

Who Can Join the Study?

  • Must be an adult aged 18 or older.
  • Must have a sample of the tumor available for research purposes.
  • Must have social security in compliance with French law.
  • Must voluntarily sign and date a written informed consent before any study-specific procedure.
  • Men must agree to use an effective method of birth control during the treatment and for one week after stopping treatment.
  • Must have a confirmed diagnosis of prostate cancer.
  • Cancer must not have spread to nearby or distant areas. This requires specific scans like Pelvic MRI, CT-Scan, and Bone Scintigraphy. Other scans may be used as per the doctor’s judgment.
  • Must have a diagnosis of unfavorable intermediate risk prostate cancer as defined by specific criteria, such as a certain Gleason score or PSA level. These are measures used to assess the cancer’s characteristics.
  • Must be newly diagnosed with this type of prostate cancer or have a previously low-risk prostate cancer that has progressed to this level within 30 days before registration.
  • Must have a life expectancy of at least 5 years.
  • Must have a performance status of ECOG 2 or less, which is a measure of daily living abilities.
  • Must not have any medical reasons that would prevent them from receiving EBRT (a type of radiation therapy), as judged by a doctor.
  • Must have adequate organ function, shown by specific blood test results, such as hemoglobin, neutrophils, platelets, bilirubin, AST, ALT, and creatinine clearance levels.

Who Cannot Join the Study?

  • Patients who are not adult males.
  • Patients who do not have intermediate unfavorable risk prostate cancer.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
Clinique Pasteur Toulouse France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Institut Sainte Catherine Avignon France
Centre Hospitalier Prive Saint-Gregoire Saint-Gregoire France
Centre Hospitalier Regional Universitaire Besançon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Anmcoreusu Ppzuqigv Hrubcwcy Dw Mcobedqjb Marseille France
Cewqeu Obkkv Lgnbnpz Lille France

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
24.02.2023

Trial locations

Investigated drugs:

Darolutamide: This medication is used in the trial to help treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, darolutamide is given to patients for a short period of six months alongside radiation therapy to see if it can help reduce the levels of prostate-specific antigen (PSA), which is a marker used to assess the presence and progression of prostate cancer.

Investigated diseases:

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It is often categorized by risk levels, such as intermediate unfavorable risk, which indicates a moderate chance of progression. The disease may initially present with no symptoms, but as it progresses, it can lead to urinary difficulties, pelvic discomfort, or bone pain. The progression of prostate cancer can vary, with some cases remaining localized while others may spread to nearby tissues or distant parts of the body. Monitoring involves tracking prostate-specific antigen (PSA) levels, which can indicate changes in the disease’s activity. The progression is often slow, but it can become more aggressive over time, necessitating regular medical evaluations.

Trial ID:
2023-509494-23-00
Protocol code:
IB 2021-03
NCT ID:
NCT05346848
Trial Phase:
Therapeutic exploratory (Phase II)

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