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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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.
  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Odense University Hospital Odense Denmark
Tartu University Hospital Tartu Estonia
Turku University Hospital Turku Finland
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Sykehuset I Vestfold HF Tonsberg Norway
Sgeknconv Tlmgvvei Hk Skien Norway
Ejfkyeubxerfomxjv hanigpfobipasib Seinajoki Finland
Hmkkbh Hydhekxd Herlev Denmark
Hovuukpz Uckwwfujrb Cmnrumd Hkyovvgk Helsinki Finland
Apddtw Ulibqvprjh Hbznoksq Aarhus Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.05.2018
Estonia Estonia
Recruiting
01.05.2018
Finland Finland
Recruiting
01.05.2018
Norway Norway
Recruiting
01.05.2018

Trial locations

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.

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.

Trial ID:
2024-517854-91-00
Protocol code:
ESTO2
Trial Phase:
Therapeutic confirmatory (Phase III)

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