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Study on Darolutamide and Androgen Deprivation Therapy for Men with Metastatic Hormone-Sensitive Prostate Cancer

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What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as metastatic hormone-sensitive prostate cancer (mHSPC). This is a condition where prostate cancer has spread to other parts of the body but still responds to hormone therapy. The study is testing a treatment called darolutamide, which is being used in combination with another treatment known as androgen deprivation therapy (ADT). The trial aims to compare the effectiveness of darolutamide plus ADT against a placebo plus ADT in men with this type of prostate cancer.

The purpose of the study is to determine if darolutamide, when added to ADT, is more effective than a placebo in improving the time patients live without their cancer getting worse, known as radiological progression-free survival. Participants in the study will receive either darolutamide or a placebo, both in addition to ADT. The study will be conducted over a period of time, and participants will be monitored to see how well the treatment works and to track any side effects.

Throughout the study, researchers will also look at other important outcomes, such as overall survival, the time it takes for the cancer to become resistant to treatment, and the time until new cancer treatments are needed. The study will also monitor changes in prostate-specific antigen (PSA) levels, which are used to track prostate cancer progression, and any pain progression experienced by participants. The trial is designed to provide valuable information on the potential benefits of darolutamide for men with metastatic hormone-sensitive prostate cancer.

1 joining the study

Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the requirements and restrictions of the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status. Blood tests and imaging scans may be performed to document the presence of metastatic prostate cancer.

3 randomization

You will be randomly assigned to one of two groups. One group will receive the study medication, darolutamide, in addition to androgen deprivation therapy (ADT). The other group will receive a placebo along with ADT.

4 treatment phase

If you are in the darolutamide group, you will take the medication in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol. The treatment will continue for the duration specified by the study, which may last until the estimated end date in 2025.

If you are in the placebo group, you will take a tablet that looks like the darolutamide tablet but does not contain the active medication. You will also continue with ADT as prescribed.

5 regular monitoring

Throughout the study, regular monitoring will be conducted. This includes scheduled visits for health assessments, blood tests, and imaging scans to track the progression of the disease and any side effects of the treatment.

6 end of treatment

At the end of the treatment phase, a final assessment will be conducted. This will include a review of your health status and any changes in your condition. The study team will discuss the next steps with you.

Who Can Join the Study?

  • Must provide written informed consent, which means you agree to participate in the study and understand what it involves.
  • If sexually active, male participants must agree to use condoms and not donate sperm during the study and for 4 weeks after. Female partners should use effective birth control.
  • Must be a male aged 18 years or older.
  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer.
  • Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by specific imaging tests like bone scans or CT/MRI scans.
  • Must have started Androgen Deprivation Therapy (ADT), a treatment to lower male hormones, no more than 12 weeks before joining the study. This can include medications or surgery to remove the testicles.
  • If taking a first-generation anti-androgen, it must be stopped at least 1 day before starting the study treatment.
  • Must have an ECOG Performance Status of 0, 1, or 2, which is a scale to assess how well you can perform daily activities.
  • Must have certain blood test results within specific ranges, including hemoglobin, neutrophil count, and platelet count, without recent growth factor treatment or blood transfusions.
  • Must have liver and kidney function tests within specific limits, including ALT, AST, total bilirubin, and creatinine levels.

Who Cannot Join the Study?

  • Patients who do not have metastatic hormone-sensitive prostate cancer (mHSPC) cannot participate. This means the cancer has spread to other parts of the body and still responds to hormone therapy.
  • Only male patients can participate in the study.
  • Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.

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
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Vidzemes Slimnica SIA Valmiera Latvia
Pauls Stradins Clinical University Hospital Riga Latvia
Virgen del Rocío University Hospital Sevilla Spain
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Hospital Universitario Puerta Del Mar Cadiz Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital San Pedro De Alcantara Caceres Spain
Fundacio Puigvert Barcelona Spain
Daugavpils regionala slimnica SIA Daugavpils Latvia
Vilnius University Hospital Vilnius Lithuania
Uro SIA Riga Latvia
Hospital Universitario Virgen De La Victoria Malaga Spain
Pojl Tignd Haqgbmas Ugavilggimob Sabadell Spain
Rbpzw Artplcdq kxlxskgi uahcafkjbmamz sadobwtr Stt Riga Latvia

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

Trial status

Country Status Recruitment Start
Latvia Latvia
Not recruiting
01.02.2021
Lithuania Lithuania
Not recruiting
01.02.2021
Spain Spain
Not recruiting
01.02.2021

Trial locations

Investigated drugs:

Darolutamide is a medication used in this clinical trial to treat men with metastatic hormone-sensitive prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down the growth of prostate cancer cells. In this study, darolutamide is being tested to see if it can improve the condition of patients when used alongside another treatment called androgen deprivation therapy (ADT).

Androgen Deprivation Therapy (ADT) is a standard treatment for prostate cancer that aims to reduce the levels of male hormones in the body. These hormones can promote the growth of cancer cells, so lowering their levels can help control the cancer. ADT is often used in combination with other treatments to enhance its effectiveness in managing prostate cancer.

Investigated diseases:

Metastatic hormone-sensitive prostate cancer (mHSPC) – This disease is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. It begins in the prostate gland and can metastasize to bones, lymph nodes, or other organs. The cancer cells in mHSPC are sensitive to androgens, which are male hormones that can promote cancer growth. As the disease progresses, it may lead to symptoms such as bone pain, urinary issues, and fatigue. Over time, the cancer may become resistant to hormone therapy, transitioning to a more advanced stage known as castration-resistant prostate cancer. The progression of mHSPC is monitored through various clinical markers, including prostate-specific antigen (PSA) levels and imaging studies.

Trial ID:
2022-502244-12-00
Protocol code:
21140
NCT ID:
NCT04736199
Trial Phase:
Therapeutic confirmatory (Phase III)

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