Recruiting

Study on Atorvastatin's Effect on Prostate Cancer Progression in Patients Undergoing Androgen Deprivation Therapy

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 the effects of the medication atorvastatin on the progression of prostate cancer in patients who are undergoing androgen deprivation therapy (ADT). Prostate cancer is a disease where cancer cells form in the tissues of the prostate, a gland in the male reproductive system. Androgen deprivation therapy is a treatment that reduces male hormones to slow the growth of cancer. The study aims to determine if atorvastatin can delay the progression of prostate cancer, specifically the development of resistance to castration, compared to a placebo during ADT for advanced prostate cancer.

Participants in the study will receive either atorvastatin, a cholesterol-lowering drug, or a placebo, which is an identical capsule without any active ingredient. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure that the results are not influenced by expectations or bias. The trial will monitor the time it takes for the disease to progress after starting ADT or antiandrogen therapy.

The study will take place over a period of time, with regular check-ups to assess the health and progress of the participants. The goal is to gather information on whether atorvastatin can be an effective addition to the treatment of prostate cancer, potentially offering a new way to manage the disease and improve patient outcomes. Participants will be closely monitored throughout the study to ensure their safety and well-being.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be asked to sign an informed consent form. This document confirms your willingness to participate and ensures you understand the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and current condition, specifically focusing on your prostate cancer diagnosis and treatment history.
Step 3
Randomization
You will be randomly assigned to one of two groups. One group will receive the active medication, atorvastatin, and the other will receive a placebo, which looks identical but contains no active ingredients.
Step 4
Medication administration
If you are in the group receiving atorvastatin, you will take a 40 mg film-coated tablet orally. The frequency and duration of administration will be specified by the study team.
If you are in the placebo group, you will take a tablet identical in appearance to the active medication, but without any active ingredient.
Step 5
Regular follow-ups
You will attend regular follow-up appointments. These appointments are designed to monitor your health, assess the progression of your prostate cancer, and evaluate any side effects or changes in your condition.
Step 6
End of study participation
Your participation in the study will conclude at the end of the trial period or if you choose to withdraw. The estimated end date for the study is December 31, 2033.

Who can join the trial?

10 criteria

Must have metastatic or high-risk recurrent prostate cancer. This means the cancer has spread to other parts of the body or has come back after treatment.
Currently receiving androgen deprivation therapy (ADT). This is a treatment to lower male hormones that can help the cancer grow.
For metastatic cancer, it must be confirmed by a doctor through tests like scans showing cancer in bones, soft tissues, or enlarged lymph nodes.
check
For high-risk recurrent cancer, it must have come back after surgery or radiotherapy, and meet one of these conditions:
- Gleason score of 8-10, which is a way to grade prostate cancer.
- PSA doubling time of 6 months or less. PSA is a protein made by the prostate, and a quick increase can indicate cancer growth.
- PSA level of 20 ng/ml or higher.
- New lymph node metastases found in imaging tests.
- Started ADT or antiandrogen therapy within the last 3 months.
- Must be male.
- Must be willing to participate and sign an informed consent form, which means you agree to join the study after understanding all the details.

Who cannot join the trial?

2 criteria

Patients who are not male cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

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

Verified
Aarhus University Hospital
Aarhus, Denmark
Verified
Helsinki University Central Hospital
Helsinki, Finland
Responsive
Sykehuset I Vestfold HF
Tonsberg, Norway

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

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

Atorvastatin is a medication commonly used to lower cholesterol levels in the blood. In this clinical trial, it is being tested to see if it can help delay the progression of prostate cancer when used alongside androgen deprivation therapy, which is a treatment that reduces male hormones to slow down the growth of prostate cancer. The researchers are interested in finding out if atorvastatin can prevent the cancer from becoming resistant to this hormone therapy.

Atorvastatin

What is already known about the treatment

Atorvastatin – Atorvastatin is administered orally in the form of a tablet. It is currently being studied in a clinical trial to assess its impact on prostate cancer progression in patients undergoing androgen deprivation therapy. The main therapeutic indication being investigated is its potential to delay the progression of metastatic or high-risk recurrent prostate cancer. At the molecular level, atorvastatin works by inhibiting an enzyme involved in cholesterol production, which may also affect cancer cell growth. It is pharmacologically classified as a statin, commonly used to lower cholesterol levels in the blood.

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. In some cases, it can spread to nearby tissues or other parts of the body, such as bones and lymph nodes. The progression can be influenced by factors like hormone levels, particularly testosterone. Over time, the cancer may become resistant to hormone therapy, a condition known as castration-resistant prostate cancer.