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Last Updated: January 21, 2025

CLINICAL TRIALS PROFILE FOR ELIGARD


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All Clinical Trials for Eligard

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005044 ↗ Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Unknown status National Cancer Institute (NCI) Phase 3 2000-02-01 RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00005044 ↗ Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer Unknown status Radiation Therapy Oncology Group Phase 3 2000-02-01 RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.
NCT00170157 ↗ Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer Completed Medarex Phase 2 2004-06-01 RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
NCT00170157 ↗ Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2004-06-01 RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Eligard

Condition Name

Condition Name for Eligard
Intervention Trials
Prostate Cancer 26
Prostate Adenocarcinoma 9
Stage IVB Prostate Cancer AJCC v8 4
Recurrent Prostate Carcinoma 4
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Condition MeSH

Condition MeSH for Eligard
Intervention Trials
Prostatic Neoplasms 47
Adenocarcinoma 13
Carcinoma 4
Neoplasms 1
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Clinical Trial Locations for Eligard

Trials by Country

Trials by Country for Eligard
Location Trials
United States 296
Canada 29
Netherlands 15
Belgium 10
Brazil 9
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Trials by US State

Trials by US State for Eligard
Location Trials
California 19
Maryland 12
Texas 11
Illinois 10
Michigan 10
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Clinical Trial Progress for Eligard

Clinical Trial Phase

Clinical Trial Phase for Eligard
Clinical Trial Phase Trials
Phase 4 6
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Eligard
Clinical Trial Phase Trials
Completed 19
Recruiting 16
Active, not recruiting 7
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Clinical Trial Sponsors for Eligard

Sponsor Name

Sponsor Name for Eligard
Sponsor Trials
National Cancer Institute (NCI) 19
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 5
Sanofi 5
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Sponsor Type

Sponsor Type for Eligard
Sponsor Trials
Other 44
Industry 31
NIH 20
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Eligard: Clinical Trials, Market Analysis, and Projections

Introduction to Eligard

Eligard is a luteinizing hormone-releasing hormone (LHRH) agonist used in the treatment of advanced prostate cancer. It works by blocking the release of luteinizing hormone, which in turn reduces the production of testosterone, a hormone that can fuel the growth of prostate cancer cells.

Clinical Trials Overview

Several clinical trials have been conducted to evaluate the efficacy and safety of Eligard in patients with prostate cancer.

Study Details

  • AGL9904, AGL9909, AGL0001, and AGL0205 Studies: These open-label, multicenter studies involved patients with Jewett stage A through D prostate cancer. The studies evaluated the achievement and maintenance of serum testosterone suppression to castration levels using different formulations of Eligard (7.5 mg, 22.5 mg, 30 mg, and 45 mg)[1].

  • Testosterone Suppression: The studies showed that once testosterone suppression was achieved, breakthrough (testosterone levels > 50 ng/dL) was rare. For example, in the AGL9904 study using Eligard 7.5 mg, no patients demonstrated breakthrough. In the AGL9909 study using Eligard 22.5 mg, only one patient (<1%) showed breakthrough after the initial injection but remained suppressed after the second injection[1].

  • PSA Reduction: All studies demonstrated significant reductions in serum PSA levels. The mean PSA reduction at the conclusion of the studies ranged from 86% to 98%, with a high percentage of patients achieving normal PSA levels[1].

Market Analysis

Current Market Size and Growth

The global prostate cancer therapeutics market, which includes Eligard, was estimated at USD 12.12 billion in 2022. This market is projected to grow at a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030, reaching USD 21.48 billion by 2030[2].

Market Segmentation

The market is segmented by drug class, distribution channel, and region. LHRH agonists, including Eligard, are a significant segment within the hormonal therapy category. Other key segments include anti-androgen therapies, chemotherapy, immunotherapy, and targeted therapies[2].

Regional Outlook

The market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America, particularly the U.S., is a major market for prostate cancer therapeutics, including Eligard[2].

Market Projections for Eligard

Sales Forecast

Historical data and market analyses suggest that Eligard, as an LHRH agonist, will continue to be a vital component in the treatment of prostate cancer. Sales forecasts for Eligard have been detailed in various reports, including those from GlobalData and Grand View Research.

  • GlobalData Report: This report provided sales forecasts for Eligard in the top nine countries from 2012 to 2022, including the U.S., Japan, UK, France, Germany, Spain, Italy, Canada, and Australia[3].

  • Grand View Research: According to Grand View Research, the global prostate cancer therapeutics market, which includes Eligard, is expected to continue growing due to increasing incidence rates of prostate cancer and advancements in treatment options[5].

Competitive Landscape

Eligard competes with other LHRH agonists such as Lupron, Zoladex, Decapeptyl, and Vantas. The market is also influenced by newer therapies like Zytiga (abiraterone acetate) and Xtandi (enzalutamide), which have been approved for various stages of prostate cancer, including metastatic castration-resistant prostate cancer (mCRPC)[3].

Distribution Channels

Eligard is marketed through various distribution channels, including hospital pharmacies, drug stores & retail pharmacies, and online pharmacies. The distribution strategy plays a crucial role in its market penetration and accessibility to patients[2].

Impact of New Approvals and Treatments

Combination Therapies

Recent approvals, such as the combination of enzalutamide and leuprolide for nonmetastatic prostate cancer with biochemical recurrence, may influence the treatment landscape and potentially impact the use of Eligard. However, LHRH agonists like Eligard remain a cornerstone in androgen deprivation therapy (ADT) due to their efficacy in suppressing testosterone levels[4].

Quality of Life and Survival

Studies like the EMBARK trial have shown that combination therapies can improve metastasis-free survival and quality of life for patients. While these findings are promising, they also highlight the ongoing role of LHRH agonists in managing prostate cancer, especially in achieving and maintaining castrate levels of testosterone[4].

Key Takeaways

  • Clinical Efficacy: Eligard has demonstrated strong efficacy in suppressing testosterone levels and reducing PSA values in clinical trials.
  • Market Growth: The global prostate cancer therapeutics market, including Eligard, is expected to grow significantly over the next decade.
  • Competitive Landscape: Eligard competes with other LHRH agonists and newer therapies, but remains a key player in ADT.
  • Distribution and Accessibility: Eligard is available through various distribution channels, ensuring its accessibility to patients.
  • Combination Therapies: New combination therapies may influence treatment approaches but do not replace the role of LHRH agonists like Eligard.

FAQs

What is Eligard used for?

Eligard is used in the treatment of advanced prostate cancer to suppress testosterone levels, which helps in controlling the growth of cancer cells.

How does Eligard work?

Eligard is an LHRH agonist that blocks the release of luteinizing hormone, thereby reducing the production of testosterone from the testes.

What were the results of the clinical trials for Eligard?

Clinical trials showed that Eligard effectively suppressed testosterone levels to castration levels and significantly reduced PSA values in patients with prostate cancer.

How does the market for Eligard look in the future?

The market for Eligard and other prostate cancer therapeutics is projected to grow at a CAGR of 8.4% from 2023 to 2030, driven by increasing incidence rates and advancements in treatment options.

Are there any new treatments that might impact the use of Eligard?

Yes, new approvals such as the combination of enzalutamide and leuprolide may influence treatment approaches, but LHRH agonists like Eligard remain crucial in achieving and maintaining castrate levels of testosterone.

Where is Eligard marketed?

Eligard is marketed by Sanofi (US, Canada), Astellas Pharma (5EU), and Hospira (Australia), among others.

Sources

  1. ELIGARD® Information Center: Clinical Studies.
  2. Grand View Research: Prostate Cancer Therapeutics Market Size Report, 2030.
  3. Business Wire: Research and Markets: Eligard (Prostate Cancer) - Forecast and Market Analysis to 2022.
  4. NCI: Xtandi Approved for High-Risk Prostate Cancer.
  5. Grand View Research Inc.: Prostate Cancer Therapeutics Market Analysis By Drugs (Zytiga, Gonax, Lupron, Zoladex, Decapeptyl, Eligard, Vantas, Casodex, Xtandi, Taxotere, Jevtana, Provenge, Xofigo), By Region, And Segment Forecasts, 2014 - 2025.

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