Ongoing Clinical Trials for Metastatic Neuroendocrine Cancer of the Prostate
There is currently 1 ongoing clinical trial for metastatic neuroendocrine cancer of the prostate. This trial is investigating whether atorvastatin, a cholesterol-lowering medication, can help delay cancer progression in patients receiving androgen deprivation therapy. The study is being conducted across multiple countries in Northern Europe and the Baltic region.
Clinical trial locations
- Denmark
- Estonia
- Finland
- Norway
Study on Atorvastatin’s Effect on Prostate Cancer Progression in Patients Undergoing Androgen Deprivation Therapy
This clinical trial is exploring whether atorvastatin, a medication commonly used to lower cholesterol, can help slow the progression of prostate cancer in patients who are receiving androgen deprivation therapy. The study is designed as a double-blind trial, meaning neither the participants nor the researchers will know who is receiving the actual medication or a placebo. This approach helps ensure unbiased results.
Inclusion criteria: To participate in this study, you must be male and have metastatic or high-risk recurrent prostate cancer. This means the cancer has either spread to other parts of the body or has returned after previous treatment. You must currently be receiving androgen deprivation therapy, which is a treatment that lowers male hormones to slow cancer growth. For metastatic cases, the cancer spread must be confirmed through medical tests such as scans showing cancer in bones, soft tissues, or enlarged lymph nodes.
For high-risk recurrent cancer, the disease must have returned after surgery or radiotherapy and meet at least one of these conditions: a Gleason score of 8-10 (a grading system for prostate cancer severity), a PSA doubling time of 6 months or less (indicating rapid cancer growth), a PSA level of 20 ng/ml or higher, or new lymph node metastases visible on imaging tests. You must have started androgen deprivation therapy or antiandrogen therapy within the last 3 months and be willing to sign an informed consent form.
Exclusion criteria: This trial is only open to male patients. Individuals who belong to vulnerable populations, such as children, pregnant women, or those unable to make decisions for themselves, cannot participate in this study.
Focus and goal: The main goal of this trial is to determine whether atorvastatin can delay the progression of prostate cancer, specifically the development of resistance to castration, when used alongside androgen deprivation therapy. Participants will attend regular follow-up appointments to monitor their health, assess cancer progression, and evaluate any side effects. The study is expected to continue until December 31, 2033.
Investigational drug: Atorvastatin is being tested in this trial at a dose of 40 mg taken orally as a film-coated tablet. While atorvastatin is typically used to lower cholesterol levels, researchers are investigating whether it may also affect cancer cell growth and help prevent the cancer from becoming resistant to hormone therapy. The medication works by inhibiting an enzyme involved in cholesterol production, which may have additional effects on cancer progression.
Summary
Currently, there is one active clinical trial investigating treatment options for metastatic neuroendocrine cancer of the prostate. This trial represents a novel approach by testing whether a commonly used cholesterol-lowering medication might offer benefits beyond its traditional use. The study is being conducted across four countries in Northern Europe and the Baltic region: Denmark, Finland, Norway, and Estonia.
The trial focuses specifically on patients who are already receiving androgen deprivation therapy and explores whether adding atorvastatin to this standard treatment can help delay disease progression. This research is particularly important because prostate cancer can eventually become resistant to hormone therapy, a condition known as castration-resistant prostate cancer. The study aims to provide valuable information about whether atorvastatin could offer a new way to manage the disease and potentially improve outcomes for patients.