Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effects of Acetylsalicylic Acid and Atorvastatin in Patients with Castration-Resistant Prostate Cancer

Verified siteRegistered 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 the effects of two medications, acetylsalicylic acid and atorvastatin, in patients with castration-resistant prostate cancer. Castration-resistant prostate cancer is a type of prostate cancer that continues to grow even when the amount of male hormones in the body is reduced to very low levels. The purpose of the study is to evaluate how these medications might improve the overall survival of patients with this condition.

Participants in the study will receive either the medications or a placebo. The study will last for a period of up to 180 days, during which the effects of the medications on the patients' health will be monitored. The medications are taken orally, meaning they are swallowed in the form of tablets. Acetylsalicylic acid is commonly known as aspirin and is often used to reduce pain, fever, or inflammation. Atorvastatin is a medication used to lower cholesterol levels in the blood.

The study aims to determine if these medications can help improve the survival rates of patients with castration-resistant prostate cancer. Throughout the study, various health parameters will be observed, including the progression of the cancer and any side effects experienced by the participants. The trial will also explore other health aspects, such as changes in body weight and cardiovascular health, to gain a comprehensive understanding of the medications' impact.

The research process

The trial runs in 5 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 must have a confirmed diagnosis of prostate cancer that is resistant to castration. The patient must be informed about the study and sign a consent form.

    The patient must be at least 18 years old with a life expectancy of at least 6 months. The patient must continue using androgen deprivation therapy if not surgically castrated.

  2. Step 2

    Medication administration

    The patient will receive two medications: acetylsalicylic acid and atorvastatin. These medications are taken orally.

    The acetylsalicylic acid is provided as a 100 mg gastro-resistant tablet, and atorvastatin is provided as an 80 mg film-coated tablet.

  3. Step 3

    Treatment monitoring

    The patient's overall survival will be monitored from the date of randomization until the date of death or the last follow-up date.

    Secondary outcomes include prostate cancer-specific survival, progression-free survival, and radiographic progression-free survival.

  4. Step 4

    Safety and side effects

    The study will monitor for any side effects related to the medications, focusing on cardiovascular events and other significant adverse effects.

    Changes in body mass index, body weight, and waist measurements will be recorded.

  5. Step 5

    Additional research

    The study includes research on metabolic parameters, vitamin D levels, and lipid profiles.

    The study will also examine the lymphocyte to neutrophil ratio and C-reactive protein levels.

Who can join the trial?

10 criteria

  • The patient must have a confirmed diagnosis of a type of prostate cancer called adenocarcinoma, and no local treatment that can cure the cancer is possible.
  • The patient must receive information about the study and sign a form agreeing to participate.
  • The patient must be at least 18 years old and expected to live for at least 6 more months.
  • The patient must have castration-resistant prostate cancer (CRPC), which means the cancer is growing despite treatments that lower testosterone. This is shown by an increase in a marker called PSA or changes seen in imaging tests. The patient must continue using certain medications if they haven't had surgery to remove the testicles.
  • The patient may or may not have cancer that has spread to other parts of the body, as shown by imaging tests.
  • The patient must have a performance status of 0, 1, or 2, which indicates how well they can perform daily activities.
  • The patient must not have used certain treatments that extend life for CRPC, except they may have used one of these treatments for up to 6 weeks before joining the study. Using these treatments with other therapies for a different stage of prostate cancer is allowed.
  • The patient must have good kidney function, shown by a test called creatinine clearance of at least 50 mL/min, and good liver function, with certain liver tests being no more than three times the normal limit and no signs of bile flow problems.
  • The patient can participate in other clinical trials, as long as those trials do not have the same main goal of improving overall survival.
  • The patient must be allowed to join a clinical trial according to the rules of their country, such as being part of a social security system.

Who cannot join the trial?

3 criteria

  • Patients who do not have castration-resistant prostate cancer cannot participate. This is a type of prostate cancer that continues to grow even when the amount of male hormones in the body is reduced to very low levels.
  • Only male patients are eligible, so female patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. This means people who might have a harder time making decisions for themselves or who might be at higher risk of harm.
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

  • Acetylsalicylic Acid

    is commonly known as aspirin. In this trial, it is being used to see if it can help improve the overall survival of patients with castrate-resistant prostate cancer. Aspirin is often used to reduce pain, fever, or inflammation, but in this study, researchers are exploring its potential benefits in cancer treatment.

  • Atorvastatin

    is a medication typically used to lower cholesterol levels in the blood. It is being tested in this trial to determine if it can contribute to improving the overall survival of patients with castrate-resistant prostate cancer. Researchers are interested in its potential effects beyond cholesterol management, particularly in cancer therapy.

What is already known about the treatment

  • Acetylsalicylic Acid

    This medication is commonly administered orally in tablet form. It is widely recognized in medical literature and is currently being studied for its potential benefits in treating castration-resistant prostate cancer. The main therapeutic indication is to improve overall survival in patients with this type of cancer. At the molecular level, acetylsalicylic acid works by inhibiting enzymes involved in inflammation and blood clotting, which may help in reducing cancer progression. It is classified as a non-steroidal anti-inflammatory drug (NSAID).

  • Atorvastatin

    This medication is typically taken orally as a tablet. It is well-established in medical practice and literature, primarily used to lower cholesterol levels, but is now being investigated for its effects on castration-resistant prostate cancer. The main therapeutic goal is to enhance overall survival in affected patients. Atorvastatin functions by inhibiting an enzyme involved in cholesterol production, which may also impact cancer cell growth. It belongs to the pharmacological class of statins.

Investigated diseases

Castration-resistant prostate cancer – This is a type of prostate cancer that continues to progress despite the reduction of testosterone to very low levels, typically achieved through medical or surgical means. The disease is characterized by the cancer cells' ability to grow even when the amount of male hormones in the body is reduced to very low levels. It often manifests with rising prostate-specific antigen (PSA) levels, indicating cancer activity, despite hormone therapy. Over time, the cancer may spread to other parts of the body, such as bones or lymph nodes, leading to additional symptoms. The progression of this cancer can vary, with some patients experiencing slow growth and others facing more rapid advancement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508072-11-00Protocol code2017/2601 PEACE 4Estimated enrolment1 230 patientsSponsorInstitut Gustave Roussy

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.