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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Hopital Tenon Paris France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Institut Godinot Reims France
Clinique De La Sauvegarde Lyon France
Polyclinique De Limoges Limoges France
Centre Hospitalier Universitaire Rouen Rouen France
Hopital NOVO Pontoise France
Scp Institut De Cancerologie Des Hauts De France Beuvry France
Unite De Recherche Clinique HIA Begin Saint-Mande France
University Hospital Olomouc Olomouc Czechia
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Clinique Victor Hugo Le Mans France
CHU De Martinique Fort De France France
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Mont-de-Marsan France
Victor Provo Hospital Roubaix France
CLINIQUE MUTUALISTE DE L’ESTUAIRE St Nazaire France
Clinique De Flandre Coudekerque Branche France
Hôpitaux du Léman Thonon-les-bains France
Hospices Civils de Lyon -Hôpital Lyon Sud Pierre Benite France
Strasbourg Oncologie Libérale – Clinique Sainte-Anne STRASBOURG, Alsace France
Hrubjco Pyufl Dsmdhikwvuoow Valence France
Cog Hchsbpj nggz (znrwzk Nuqypjamr Saint Priest En Jarez France
Cpwtlm hyvnbezcdkd dk Ryypzg Roanne France
Cid dluwrzyxssizjoj Orléans France
Htljepra Cycvcm dy Cdkzzq Colmar France
Chhjga Amiragw de Csakdfwxpenf Mougins France
Bmppcseu Ufefdgwtdy Hgwkfbkv Ckqwdy Besançon France
Cgfmaj Hywzpfmzvwo Rpgvrbrf Uvshhenvquwgk Dq Tgmdm Tours France
Cjzlfg Owbei Ldlsxok Lille France
Cdeljw Hojmxwlqpjo Urbnqdtzmqfee dj lj Ghipnkglex Pointe A Pitre France
Hjuhujnn Uctmulnayxqbpu Scdxtetxep &txesmv Hnislrl dp Hsqpdwrocrd STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
26.06.2019
France France
Recruiting
26.06.2019

Trial locations

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.

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 ID:
2023-508072-11-00
Protocol code:
2017/2601 PEACE 4
NCT ID:
NCT03819101
Trial Phase:
Therapeutic confirmatory (Phase III)

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