Phase III Randomized Trial Evaluating Adjuvant Leuprorelin Acetate Therapy Post-Radical Prostatectomy in High-Risk Prostatic Adenocarcinoma Patients

The primary objective of this study is to evaluate the effectiveness of adjuvant hormonal treatment with **leuprorelin acetate** (Eligard® 45 mg) administered for 24 months following radical prostatectomy in patients with **prostatic adenocarcinoma** at high risk of recurrence. The primary endpoint is survival without metastases over a 10-year period. This is clinically relevant as it aims to determine the long-term benefits of hormonal therapy in preventing metastatic progression in high-risk patients, potentially improving overall patient outcomes.

Secondary objectives include:

• Monitoring the evolution of **PSA** levels, which is crucial for assessing disease progression or recurrence.
• Evaluating testosterone levels to understand the hormonal impact of the treatment.
• Assessing specific survival and overall survival rates to provide a comprehensive view of the treatment's efficacy.
• Determining treatment tolerance to ensure patient safety and manage adverse effects.
• Evaluating quality of life using QLQ-C30 questionnaires to measure the impact of treatment on patients' daily living and well-being.

The clinical trial focuses on patients diagnosed with **prostatic adenocarcinoma** at high risk of recurrence. The sponsor has not provided information regarding the total number of participants. The study population includes both male and female subjects, aged 18 years and older, with a life expectancy of at least 10 years. Participants are required to have undergone a radical prostatectomy, with or without extended pelvic lymphadenectomy, within the three months preceding inclusion. The trial does not involve a vulnerable population. Participants must have a Performance Status (ECOG) of 2 or less and meet specific health criteria, including histologically confirmed prostatic adenocarcinoma, postoperative PSA levels below 0.1 ng/mL, and adequate blood counts and liver function. The selection process involves patients who have received an information leaflet and signed a consent form, and who are affiliated with a social security scheme. Lifestyle factors such as diet and physical activity are not specified as part of the selection criteria.

The clinical trial is a **randomized**, **controlled**, **double-blind** Phase III study designed to evaluate the benefit of adjuvant hormonal treatment with **leuprorelin acetate** (Eligard® 45 mg) for 24 months following radical prostatectomy in patients with prostatic adenocarcinoma at high risk of recurrence. The primary objective is to assess the effectiveness of the treatment in terms of survival without metastases over a 10-year period. Secondary endpoints include the evaluation of PSA progression, testosterone levels, specific survival, overall survival, treatment tolerance, and quality of life using QLQ-C30 questionnaires.

The trial is expected to run from July 6, 2011, to December 31, 2027. Participants will be involved for a maximum of 24 months, corresponding to the treatment duration. The study includes several key visits: an initial screening visit to confirm eligibility, regular follow-up visits to monitor treatment effects and safety, and an end-of-study visit to assess final outcomes. Inclusion criteria require participants to be at least 18 years old, with a life expectancy of at least 10 years, and to have undergone radical prostatectomy within the preceding three months. Exclusion criteria are not specified in the provided data.

Participants may be withdrawn from the study if they experience significant adverse effects, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The study is not classified as low intervention, and the investigational product is administered as a solution for injection. The trial is conducted under the sponsorship of RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A., with the investigational product being Eligard® 45 mg, a hormonotherapy agent. The trial's design ensures rigorous assessment of the treatment's efficacy and safety in the specified patient population.

The clinical trial involves the administration of **leuprorelin acetate**, marketed under the name ELIGARD 45 mg, poudre et solvant pour solution injectable. This experimental medication is provided in the form of a powder and solvent for solution injection. The pharmaceutical form is a **solution for injection**, and it is administered via this route. The dosage is set at 45 mg, with a maximum total dose amount of 180 mg over the course of the treatment. The treatment period is defined as 24 months, with the medication being administered as part of a hormonotherapy regimen. The active substance, leuprorelin acetate, is classified under the ATC code L02AE02, indicating its role in hormonal therapy. The product is manufactured by RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. and is not a paediatric formulation.

In this trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of the experimental medication, ELIGARD 45 mg, to evaluate its effectiveness in terms of survival without metastases over a 10-year period following radical prostatectomy in patients with a high risk of recurrence. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment protocol.

Efficacy in this clinical trial will be assessed primarily through the evaluation of survival without metastases over a 10-year period. This assessment will focus on the effectiveness of adjuvant hormonal treatment with **leuprorelin acetate** (Eligard® 45 mg) administered for 24 months following radical prostatectomy in patients at high risk of recurrence. In the event of biological recurrence, the presence of metastases will be determined using abdominal-pelvic CT scans (or MRI) and bone scintigraphy.

Secondary endpoints include the evaluation of prostate-specific antigen (PSA) progression, testosterone levels, specific survival, overall survival, treatment tolerance, and quality of life, which will be measured using the QLQ-C30 questionnaires. These parameters will be collected and analyzed at specified intervals throughout the trial to provide a comprehensive assessment of the treatment's efficacy and impact on patient outcomes.