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Study on Enzalutamide for Patients with Localized Prostate Cancer Undergoing Robotic-Assisted Surgery

Registered drug
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying changes in patients with localized prostate cancer. The treatment being investigated is a medication called Enzalutamide, which is provided in the form of 40 mg soft capsules. The purpose of the study is to understand the molecular changes that occur in patients who are treated with Enzalutamide for four weeks before undergoing a surgical procedure known as robotic-assisted radical prostatectomy. This surgery is a common treatment for prostate cancer, where the prostate gland is removed with the help of robotic technology.

Participants in the study will be divided into two groups: one group will receive Enzalutamide, and the other group will not receive the medication. The study aims to observe and compare the molecular and cellular changes in both groups. These changes will be measured by looking at receptor activity, which is a way to understand how cells in the body respond to the treatment. The study will help researchers learn more about how Enzalutamide affects prostate cancer at a molecular level.

The trial will last for a period of four weeks, during which participants will take the medication orally. The study will provide valuable insights into the effects of Enzalutamide on prostate cancer, potentially leading to improved treatment strategies in the future. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the medication's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing the informed consent form. This confirms understanding and agreement to participate in the study.

    Eligibility includes being over 18 years old, having localized high-risk prostate cancer, and planning to undergo surgery as a treatment.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline data. This may include medical history review and necessary screening evaluations.

  3. Step 3

    Treatment with enzalutamide

    The treatment involves taking Xtandi (enzalutamide) 40 mg soft capsules orally.

    The medication is administered daily for a duration of 4 weeks.

  4. Step 4

    Surgery

    After the 4-week treatment period, a robotic-assisted radical prostatectomy is performed. This is a surgical procedure to remove the prostate gland.

  5. Step 5

    Post-treatment assessment

    Following surgery, assessments are conducted to study molecular and cellular changes caused by the treatment.

    These assessments focus on analyzing molecular alterations in prostate cancer cells.

Who can join the trial?

6 criteria

  • Must be a male patient.
  • Must be over 18 years old at the time of signing the consent form.
  • Must have been diagnosed with localized high-risk prostate cancer. This means the cancer is in the prostate and is considered high-risk for spreading.
  • Must be a candidate for a radical prostatectomy, which is a surgery to remove the prostate gland as a treatment option.
  • Must have decided to undergo surgery with the intent to cure the cancer.
  • Must sign the informed consent form before any study-related activities, including necessary health checks, begin.

Who cannot join the trial?

4 criteria

  • Patients who are not male cannot participate.
  • Patients who do not have prostate cancer cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
  • Patients who are part of a vulnerable population, which means groups that might need special protection, cannot participate.
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Investigated drugs

Enzalutamide is a medication used in this clinical trial to treat patients with localized prostate cancer. It works by blocking the action of male hormones that can promote the growth of cancer cells. In this study, patients receive Enzalutamide for 4 weeks before undergoing robotic-assisted radical prostatectomy, which is a surgical procedure to remove the prostate gland. The trial aims to observe the molecular and cellular changes in patients treated with Enzalutamide compared to those who are not treated with it.

What is already known about the treatment

Enzalutamide – Enzalutamide is administered orally in the form of capsules. It is currently used in the treatment of prostate cancer and is well-documented in medical literature for this purpose. The main therapeutic indication for Enzalutamide is prostate cancer, particularly in cases where the cancer is resistant to other treatments. At the molecular level, Enzalutamide works by blocking the action of androgens, which are male hormones that can promote the growth of cancer cells. It belongs to the pharmacological class of antiandrogens, which are medications that inhibit the effects of androgens in the body.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. As the cancer progresses, it may spread to nearby tissues or other parts of the body. Early stages often show no symptoms, but as it advances, symptoms like difficulty urinating or pelvic discomfort may occur. The growth rate of prostate cancer can vary, with some types growing slowly and others more aggressively. Understanding the molecular and cellular changes in prostate cancer is crucial for developing effective treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514786-19-01Protocol codePROSEMAEstimated enrolment30 patientsSponsorAsociacion Instituto De Investigacion Sanitaria Biobizkaia

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).