#1 Clinical Trials Search in Europe

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

3 1 1 1

What is this study about?

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.

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 initial assessment

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

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 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 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 Study?

  • 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 Study?

  • 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.

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
Hospital Universitario Basurto Bilbao Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
15.09.2024

Trial locations

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.

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 ID:
2024-514786-19-01
Protocol code:
PROSEMA
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Use of [18F]PSMA-1007 PET/CT Imaging for Detecting Prostate Cancer in Patients with Newly Diagnosed High-Risk or Very-High-Risk Conditions

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany Italy The Netherlands Spain

  • A study of saruparib with radiotherapy and hormone therapy for men with high-risk prostate cancer who have a BRCA gene mutation

    Recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Finland France Germany Hungary +5