Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

Fast replyRegistered drugNo placebo
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 clinical trial is focused on studying treatments for metastatic prostate cancer, which is a type of cancer that has spread beyond the prostate gland. The study aims to evaluate the effectiveness of different treatment options based on specific genetic markers found in the cancer cells. These markers are identified through a process involving circulating tumor DNA (ctDNA) or tumor tissue DNA. The goal is to determine which treatment works best for patients with these specific markers, compared to the standard treatments currently available.

The trial involves several medications, including abiraterone, capivasertib, enzalutamide (also known as MDV3100), niraparib, darolutamide (also known as ODM-201 or BAY 1841788), cabazitaxel, olaparib, docetaxel, and radium ra 223 dichloride. These medications are used in different combinations to see how well they work in slowing down the progression of the cancer. Some of these drugs are taken orally as tablets, while others are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

Participants in the study will receive one of these treatments or a placebo, and their progress will be monitored over time to see how the cancer responds. The study will help researchers understand which treatments are most effective for patients with specific genetic markers, potentially leading to more personalized and effective treatment options for those with metastatic prostate cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide informed consent, indicating understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, physical examination, and necessary imaging tests such as CT or MRI scans to document metastatic disease.

  3. Step 3

    Treatment assignment

    The patient will be randomly assigned to a treatment group based on biomarker analysis. This analysis uses DNA from tumor tissue or blood to determine the most suitable treatment class.

  4. Step 4

    Treatment administration

    The patient will receive one of the following treatments, depending on the assigned group:

    Abiraterone: Oral administration, dosage as prescribed by the study protocol.

    Capivasertib: Oral administration, dosage as prescribed by the study protocol.

    Enzalutamide: Oral administration, dosage as prescribed by the study protocol.

    Niraparib and Abiraterone Acetate: Oral administration, dosage as prescribed by the study protocol.

    Cabazitaxel: Administered via intravenous infusion, dosage as prescribed by the study protocol.

    Olaparib: Oral administration, dosage as prescribed by the study protocol.

    Darolutamide: Oral administration, dosage as prescribed by the study protocol.

    Radium Ra 223 Dichloride: Administered via intravenous route, dosage as prescribed by the study protocol.

  5. Step 5

    Monitoring and follow-up

    The patient will be monitored regularly to assess treatment effectiveness and side effects. This includes blood tests, imaging studies, and questionnaires about quality of life.

    Progression-free survival will be evaluated to determine the time until disease progression or lack of clinical benefit.

  6. Step 6

    Completion of the study

    The study is estimated to end by December 31, 2026. Upon completion, the patient will undergo a final assessment to evaluate overall health and treatment outcomes.

Who can join the trial?

9 criteria

  • Male patients, aged over 18 years, with confirmed prostate cancer.
  • Starting treatment for cancer that has spread to other parts of the body.
  • Includes patients with newly diagnosed cancer that still responds to hormones or cancer that has progressed despite low testosterone levels.
  • Cancer spread must be confirmed by imaging tests like bone scans, CT, or MRI.
  • Must be in good health to receive all treatments in the study, with adequate blood, liver, and kidney function.
  • Albumin level in the blood must be 28 g/L or higher.
  • Performance status, which measures daily living abilities, should be between 0 and 2 on the ECOG/WHO scale.
  • Must be able to understand the study information and sign a consent form.
  • Must agree to use effective birth control during the study and for 6 months after, and not donate sperm during this time.

Who cannot join the trial?

4 criteria

  • Patients who do not have prostate cancer cannot participate.
  • Patients who are not male cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it's important to check if you fall within it.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, cannot 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.

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.

RecruitingNot yet 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

  • Abiraterone

    is a medication used to treat prostate cancer by lowering the levels of male hormones in the body, which can help slow the growth of cancer cells.

  • Enzalutamide

    is a treatment for prostate cancer that works by blocking the effects of male hormones, which can help prevent cancer cells from growing and spreading.

  • Docetaxel

    is a chemotherapy drug used to treat prostate cancer by interfering with the growth and division of cancer cells, ultimately leading to their death.

  • Cabazitaxel

    is another chemotherapy medication used for prostate cancer, particularly when other treatments have not been effective. It works by stopping cancer cells from dividing and growing.

  • Olaparib

    is a targeted therapy used in prostate cancer treatment that works by interfering with the cancer cells' ability to repair their DNA, leading to cell death.

  • Radium-223

    is a radiopharmaceutical used to treat prostate cancer that has spread to the bones. It works by delivering targeted radiation to the cancer cells in the bones, helping to relieve pain and slow the progression of the disease.

What is already known about the treatment

Prostate Cancer Medication – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating metastatic prostate cancer. It is in the experimental phase, with ongoing research to determine its benefits compared to standard treatments. The main therapeutic indication is for patients with hormone-sensitive and castration-resistant prostate cancer. The medication works by targeting specific biomarkers identified in circulating tumor DNA or tumor tissue DNA, aiming to improve progression-free survival. It falls under the pharmacological classification of targeted cancer therapies, focusing on molecular pathways involved in cancer growth.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can lead to difficulties in urination, blood in urine, or pelvic discomfort. The disease can spread to nearby tissues or distant parts of the body, such as bones and lymph nodes. There are different stages, including metastatic hormone-sensitive and castration-resistant prostate cancer, which indicate how far the cancer has spread and how it responds to hormone therapy. Understanding the progression of prostate cancer is crucial for determining the most effective treatment strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506857-40-00Estimated enrolment2 330 patientsSponsorKarolinska Institutet

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.