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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Clinique Pasteur	Toulouse	France
CHU de Rouen – Hôpital Charles Nicolle	Rouen	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Hospital Edouard Herriot	Lyon	France
Hopital Prive Toulon Hyeres Sainte Marguerite	Hyeres	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Centre Hospitalier Regional Universitaire	Besançon	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Hopital Prive Des Cotes D’armor	Plerin	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
CHU de Toulouse – Hôpital Pierre-Paul Riquet	Toulouse	France
Nouvel Hopital Civil Strasbourg	STRASBOURG, Alsace	France
Nouvelle Clinique de Tours Plus St Gatien Alliance par abreviation NCT St Gatien + Alliance ou NCT+	Saint-Cyr-Sur-Loire	France
Ieaotlsb Mmnlbzgozj Muhaqgoadx	Paris	France
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Czrwrgkr dq Cko dvwk Eappn	La Seyne-sur-Mer	France
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Auhfhsqsbx Pktopmhq Hsvgtumu Du Pppdu	Paris	France
Avnksvehcw Pfyniljn Hisnbbth Dz Mbficozug	Marseille	France
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Imoecufq dt Cdoxlyjhkmzq Hcvrnpnhezq Udwzqaendmddn dm Sckae Eapswyq (throhqw	Saint Priest En Jarez	France
Iopsilsq Phwvydpbiylcmal Cbrpzb Cncyps	Marseille	France
Coodfv Hkvmixwkrza Uifsixomgbjjl dg lk Gtcesfotxs	Pointe A Pitre	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	06.07.2011

Trial locations

Investigated drugs:

Leuprorelin Acetate

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.

Investigated diseases:

Prostate cancer

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.

Trial ID:

2024-515171-35-00

Protocol code:

UC-0160/1003

NCT ID:

NCT01442246

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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