Not recruiting

Study on Hormonal Treatment with Leuprorelin Acetate for Prostate Cancer Patients at High Risk of Recurrence After Surgery

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a type of cancer called prostate cancer, specifically in patients who have a high risk of the cancer returning after surgery. The treatment being tested is a hormonal therapy using a medication called leuprorelin acetate, which is marketed under the name Eligard. This medication is given as an injection and is intended to help prevent the cancer from coming back after a patient has undergone a surgical procedure known as a radical prostatectomy, which involves the removal of the prostate gland.

The purpose of the study is to evaluate how effective this hormonal treatment is in preventing the spread of cancer over a period of 10 years. Patients participating in the study will receive the leuprorelin acetate treatment for 24 months. During this time, researchers will monitor the patients' health, focusing on whether the cancer returns or spreads to other parts of the body. The study will also look at other factors such as changes in PSA levels, which is a protein produced by the prostate, and testosterone levels, as well as the overall survival and quality of life of the patients.

Throughout the study, patients will undergo regular check-ups and tests, including imaging scans like CT or MRI to check for any signs of cancer spread. The study aims to provide valuable information on the long-term benefits of using leuprorelin acetate as an additional treatment after surgery for those at high risk of prostate cancer recurrence.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have received the information leaflet and signed the consent form.
Eligibility includes being at least 18 years old with a life expectancy of at least 10 years, and having undergone a radical prostatectomy within the last 3 months.
Step 2
Initial assessment
An initial assessment is conducted to confirm the patient's medical condition, which is prostatic adenocarcinoma with a high risk of recurrence.
The assessment includes checking the postoperative PSA level, which should be less than 0.1 ng/mL, and other blood tests to ensure normal levels of neutrophils, platelets, bilirubin, ASAT, ALAT, and creatinine.
Step 3
Treatment administration
The patient receives leuprorelin acetate (Eligard® 45 mg) as a solution for injection.
This treatment is administered every 6 months for a total duration of 24 months.
Step 4
Regular monitoring
Throughout the treatment period, regular monitoring is conducted to evaluate the effectiveness of the treatment.
This includes assessments of PSA progression, testosterone levels, and overall survival.
Step 5
End of treatment evaluation
At the end of the 24-month treatment period, a comprehensive evaluation is performed.
The evaluation focuses on survival without metastases, tolerance to the treatment, and quality of life using QLQ-C30 questionnaires.
Step 6
Long-term follow-up
The study aims to evaluate the effectiveness of the treatment in terms of survival without metastases over a period of 10 years.
In case of biological recurrence, further imaging tests such as CT scans or MRIs and bone scintigraphy may be conducted to check for metastases.

Who can join the trial?

10 criteria

Patients who have received the information leaflet and signed the consent form.
Patients who are part of a social security scheme.
Patients who are 18 years or older and expected to live at least 10 more years.
Patients with a Performance Status (ECOG) of 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients who had a radical prostatectomy (surgery to remove the prostate) with or without extended pelvic lymphadenectomy (removal of lymph nodes) within the last 3 months.
Patients with a confirmed diagnosis of prostatic adenocarcinoma, a type of prostate cancer.
Patients with specific cancer characteristics: R0, N0 or Nx, or N+ (2 or fewer nodes affected), M0, and at least one of the following: a Gleason score greater than 7, a Gleason score of 7 with high-grade patterns, or stage pT3b. The Gleason score is a system to evaluate the aggressiveness of prostate cancer.
Patients with a postoperative PSA level of less than 0.1 ng/mL, measured within 2 months after surgery. PSA is a protein produced by the prostate, and its levels can indicate cancer activity.
Patients with neutrophils (a type of white blood cell) of at least 1500/mm³ and platelets (cells that help with blood clotting) of at least 100,000/mm³.
Patients with bilirubin levels within the normal range, except for those with Gilbert’s syndrome, a condition that affects bilirubin levels. ASAT and ALAT (liver enzymes) should be no more than 1.5 times the normal limit, and creatinine (a waste product in the blood) should be less than 140 μmol/L or clearance greater than 60 mL/min.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than the one being studied.
Patients who have had a different treatment for their cancer that is not part of the study.
Patients who have other serious health conditions that might interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medication or its ingredients.
Patients who have had a recent surgery or medical procedure that might affect the study results.
Patients who have a history of drug or alcohol abuse that might interfere with the study.
Patients who have a mental health condition that might affect their ability to participate in the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre Hospitalier Et Universitaire De Limoges
Limoges, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Leuprorelin acetate: This medication is used as a hormonal treatment to help prevent the recurrence of prostate cancer after surgery. It works by reducing the levels of certain hormones in the body that can promote the growth of cancer cells. In this trial, it is given to patients for 24 months following a radical prostatectomy, which is a surgery to remove the prostate gland.

Leuprorelin Acetate

What is already known about the treatment

Leuprorelin Acetate (Eligard® 45 mg) – This medication is administered as an injection under the skin, typically every six months. It is currently being studied in clinical trials for its effectiveness in preventing the recurrence of prostate cancer after surgery. The main therapeutic use of leuprorelin acetate is to reduce the risk of cancer returning in patients with high-risk prostate cancer. It works by lowering the levels of certain hormones in the body, which can slow or stop the growth of cancer cells. Leuprorelin acetate is classified as a gonadotropin-releasing hormone (GnRH) agonist, which helps manage hormone-sensitive conditions.

Investigated diseases

Prostate Adenocarcinoma with High Risk of Recurrence – This is a type of cancer that originates in the prostate gland, which is part of the male reproductive system. It is characterized by the abnormal growth of cells in the prostate, forming a tumor. In cases with a high risk of recurrence, the cancer is more likely to return after initial treatment, such as surgery. The disease may progress by spreading to nearby tissues or other parts of the body, a process known as metastasis. Monitoring involves regular assessments to detect any signs of cancer returning or spreading. The progression can vary, and it is important to track changes in specific markers like PSA levels.