Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

Eligard

Clinical Study Manager

The purpose of this study is to investigate the effect of the study medication (Eligard®) on cancer markers (in the blood) of prostate cancer.

The main objective of the study is to explore the effect of Eligard® on the following prostate cancer biomarkers:

Testosterone in serum, Prostate Specific Antigen (PSA) in serum, Prostate Cancer Antigen (PCA3 score) in urine, PSA mRNA in blood/Peripheral Blood Mononuclear Cell (PBMC), PCA3 mRNA in blood/PBMC, Transmembrane protease, serine 2-Ets Related Gene (TMPRSS2-ERG) mRNA in blood/PBMC

A blood sample for RNA analysis will also be collected and stored for future investigation in patients giving specific informed consent.

A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease

An Exploratory, Open Label, Single-arm Study to Evaluate the Effect of Eligard® 6-month on Biomarkers of Disease in Patients With Metastatic Prostate Cancer

Astellas Pharma Europe Ltd.

The protocol is designed to recruit patients who have undergone prostatectomy and high risk features of the disease were found post-operatively or for patients that, after prostatectomy, a PSA rise has been documented will be enrolled in the Phase II trial. Patients will receive Eligard injection 8-12 weeks before starting radiation. The second injection is given 12 weeks after the first one concomitant with radiation therapy.

Eligard dose of 22.5mg given, 50Gy in 20 treatments of radiation therapy to start 12 weeks after first injection concurrent with second injection of Eligard

Luis Souhami, MD

Marianna Perna, CCRP

Luis Souhami, M.D.

Marianna Perna

Tatiana Carvalho

Fabio Cury, MD

Marie Duclos, MD

Sergio Faria, MD

Prostate cancer is the second most common cancer among Canadian men of which approximately 20-30% present with high-risk tumour characteristic.

Although surgery can be curative in patients evidencing pathological high-risk disease (extracapsular extension, seminal vesicle involvement, positive surgical margins), a large proportion will develop biochemical failure within years from the surgical procedure. The failure rate is even more pronounced in those patients that present with high prostate specific antigen (PSA) levels, pT3 disease, positive margins and Gleason score ≥8 with an estimated 75% failure rate at 10 years.

Post-operative radiotherapy (RT) has been shown in three randomized trials to significantly decrease the biochemical failure rate and in one of the trials a survival benefit was also seen with the addition of post-operative RT and is considered by many investigators standard therapy in patients with pathological high-risks factors even in absence of biochemical failure.

Although RT is known to potentially eradicate microscopic disease localized in the prostatic bed, the current dilemma is whether to deliver RT in the adjuvant setting (defined as the use of RT post-prostatectomy to patients at a higher risk of recurrence because of adverse pathological features prior to evidence of disease recurrence (i.e., with an undetectable PSA) or to use it as an early salvage therapy (defined as the use of RT in patients with rising PSA but no evidence of metastatic disease).

There are several institutional retrospective reports on the use of RT as salvage therapy but no randomized trial has ever been completed. The best evidence available, however, supports early salvage RT as the best strategy to be used to maximize results.

Our own group has shown excellent results using this approach in patients with low and intermediate risk disease and is currently exploring this approach in patients with high-risk disease. Hypofractionated RT offers a more convenient shorter course of treatment, reduces health-costs and appears to be as effective and safe as conventionally fractionated regimens.

This Phase 2 trial will study the potential role of hypofractionated in the post-operative setting in patients with high-risk features with the primary objective of assessing toxicity from this approach.

The use of androgen deprivation therapy in combination with RT in the primary treatment for patients with intermediate or high-risk prostate cancer is well established. The use of androgen suppression in the post-operative setting has been less explored and its definitive role has not been fully explored.

This is a phase II clinical trial to assess the feasibility and overall toxicity of adding one injection of neo-adjuvant hormonal therapy starting 12 weeks before plus Hypofractionated Radiotherapy for four weeks concurrently with another injection of luteinizing hormone-releasing hormone (LHRH) analog in patients with post-operative setting in patients with high-risk features.

Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer

Postoperative Hypofractionated Radiation Therapy and Hormonal Therapy in Patients With Prostate Cancer: A Phase II Trial

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity. Assessments will be collected at baseline and at the end of 5 years of follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded

Number of Participants With Treatment-Related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events v.5.0 (CTCAE v5.0), Change From Baseline in genito-urinary and gastrointestinal toxicity up to 12 Weeks. Assessments will be collected at baseline and at the end of radiotherapy treatment and in follow-up.

Number of Participants With Treatment-Related Adverse Events as Assessed by the CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity up to 12 Weeks. Assessments will be collected before and at the end of radiotherapy treatment and in follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in genito-urinary and gastrointestinal toxicity. Assessments will be collected at baseline and up to 5 years of follow-up. For each symptom i.e., frequency, severity, the worst score experienced by the patient will be recorded will be collected before and at the end of radiotherapy treatment and in follow-up.

Sanofi

McGill University Health Centre/Research Institute of the McGill University Health Centre

Professor -

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Eligard 45 mg Exposure

Central Contact

Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.

This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.

An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation

Prospective Multicenter Observational Program for Evaluation of Efficacy and Tolerability of the 6-month Depot Eligard 45 mg in Patients With Advanced Prostate Carcinoma in Routine Clinical Practice of Uro-Oncologists in the Russian Federation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease	NCT01933022	Metastatic Pros...	Eligard	18 Years -	Astellas Pharma Inc
A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease	NCT01933022	Metastatic Pros...	Eligard	18 Years -	Astellas Pharma Inc
A Study in Patients With Metastatic Prostate Cancer to Assess How the Drug Eligard®, Affects Certain Markers in Blood and Urine, Which Are Indicators for the Disease	NCT01933022	Metastatic Pros...	Eligard	18 Years -	Astellas Pharma Inc
Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer	NCT04249154	Prostate Cancer	Eligard	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation	NCT02128334	Advanced Prosta...	Eligard 45 mg E...	18 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for eligard

Every month we try and update this database with for eligard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eligard

Every month we try and update this database with for eligard cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eligard cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.