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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR VIADUR


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All Clinical Trials for Viadur

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT00170157 ↗ Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer Completed U.S. Army Medical Research Acquisition Activity 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 United States Department of Defense 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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Viadur

Condition Name

954400123456789Prostate AdenocarcinomaProstate CancerStage IVB Prostate Cancer AJCC v8Recurrent Prostate Carcinoma[disabled in preview]
Condition Name for Viadur
Intervention Trials
Prostate Adenocarcinoma 9
Prostate Cancer 5
Stage IVB Prostate Cancer AJCC v8 4
Recurrent Prostate Carcinoma 4
[disabled in preview] 0
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Condition MeSH

181230024681012141618Prostatic NeoplasmsAdenocarcinomaCarcinomaGranulosa Cell Tumor[disabled in preview]
Condition MeSH for Viadur
Intervention Trials
Prostatic Neoplasms 18
Adenocarcinoma 12
Carcinoma 3
Granulosa Cell Tumor 1
[disabled in preview] 0
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Clinical Trial Locations for Viadur

Trials by Country

+
Trials by Country for Viadur
Location Trials
United States 224
Canada 9
Puerto Rico 1
Mexico 1
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Trials by US State

+
Trials by US State for Viadur
Location Trials
California 13
Texas 9
Michigan 8
Illinois 8
North Carolina 8
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Clinical Trial Progress for Viadur

Clinical Trial Phase

20.0%5.0%65.0%10.0%002468101214Phase 3Phase 2/Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Viadur
Clinical Trial Phase Trials
Phase 3 4
Phase 2/Phase 3 1
Phase 2 13
[disabled in preview] 2
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Clinical Trial Status

38.9%22.2%16.7%22.2%033.544.555.566.57RecruitingCompletedTerminated[disabled in preview]
Clinical Trial Status for Viadur
Clinical Trial Phase Trials
Recruiting 7
Completed 4
Terminated 3
[disabled in preview] 4
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Clinical Trial Sponsors for Viadur

Sponsor Name

trials024681012141618National Cancer Institute (NCI)City of Hope Medical CenterNRG Oncology[disabled in preview]
Sponsor Name for Viadur
Sponsor Trials
National Cancer Institute (NCI) 18
City of Hope Medical Center 3
NRG Oncology 2
[disabled in preview] 6
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Sponsor Type

45.0%40.0%10.0%5.0%024681012141618NIHOtherIndustry[disabled in preview]
Sponsor Type for Viadur
Sponsor Trials
NIH 18
Other 16
Industry 4
[disabled in preview] 2
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Viadur (Leuprolide Acetate Implant): Clinical Trials, Market Analysis, and Projections

Introduction to Viadur

Viadur, a leuprolide acetate implant, is a synthetic nonapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). It is designed to deliver leuprolide acetate continuously for 12 months using the innovative DUROS technology, a titanium implant drug-delivery system[4].

Clinical Trials Overview

Viadur was evaluated in two open-label, non-comparative, multicenter studies involving 131 patients with advanced prostate cancer. These studies assessed the efficacy and safety of Viadur over a period of up to two years.

  • Primary Efficacy Endpoint: The primary focus was on the suppression of serum testosterone levels. In one study, 51 patients were treated with either one or two implants for 12 months. The other study involved 80 patients treated with one implant for 12 months[1][4].
  • Secondary Endpoint: Serum Prostate Specific Antigen (PSA) was monitored. At six months, PSA concentrations decreased by at least 90% in 74.2% of the 97 evaluable patients[1][4].
  • Adverse Events: The trials reported a transient increase in serum testosterone concentrations during the first week of treatment, which could exacerbate symptoms such as bone pain, neuropathy, and urinary obstruction. Common adverse events included nocturia, urinary frequency, testis atrophy or pain, breast pain, and impotence[3][4].

Safety and Efficacy

  • Testosterone Suppression: Continuous administration of leuprolide acetate results in decreased levels of LH and FSH, leading to a reduction in testosterone to castrate levels within 2 to 4 weeks after initiation of treatment[1][4].
  • PSA Reduction: Significant reductions in PSA concentrations were observed, indicating the efficacy of Viadur in managing prostate cancer[1][4].
  • Adverse Events: Besides the expected pharmacologic consequences of testosterone suppression, other adverse events included general pain, chills, abdominal pain, malaise, dry mucous membranes, and various gastrointestinal, hematologic, metabolic, musculoskeletal, nervous, skin, and urogenital symptoms[3].

Market Analysis

Market Demand and Discontinuation

Despite its efficacy, the marketing of Viadur was phased out by April 2008 due to diminished market demand and growing manufacturing costs. Bayer HealthCare Pharmaceuticals concluded that Viadur had limited long-term market viability, although the decision was not based on safety or efficacy issues[2].

Global Leuprorelin Market

While Viadur itself is no longer marketed, the broader market for leuprorelin drugs, which include other formulations of leuprolide acetate, is growing. The global leuprorelin drugs market was estimated at US$ 2.60 billion in 2023 and is projected to grow to US$ 4.78 billion by 2034, with a compound annual growth rate (CAGR) of 5.7% from 2024 to 2034. This growth is driven by increasing cases of prostate and breast cancer, as well as growing investments in healthcare[5].

Regional Growth

The Asia Pacific region is expected to grow at the fastest rate during the forecast period, driven by large-scale pharmaceutical production and export capabilities. This region is home to some of the world's second and third-largest pharmaceutical industries[5].

Projections and Future Outlook

Market Expansion

The demand for leuprorelin drugs, including other formulations of leuprolide acetate, is expected to continue growing due to their efficacy in treating various hormone-related health issues, such as prostate cancer, endometriosis, and precocious puberty.

Technological Advancements

While Viadur's unique DUROS technology was innovative, future advancements in drug delivery systems could lead to more efficient and patient-friendly treatments. This could include improvements in implant design, drug release mechanisms, and minimally invasive insertion techniques.

Regulatory and Clinical Considerations

Future products will need to undergo rigorous clinical trials to ensure safety and efficacy. Regulatory approvals will be crucial, and manufacturers must be aware of the evolving regulatory landscape to bring new products to market successfully.

Key Takeaways

  • Clinical Efficacy: Viadur was effective in suppressing serum testosterone and PSA levels in patients with advanced prostate cancer.
  • Market Discontinuation: Despite its efficacy, Viadur's marketing was discontinued due to low market demand and high manufacturing costs.
  • Growing Market: The global leuprorelin market is expected to grow significantly, driven by increasing healthcare investments and rising cases of hormone-related diseases.
  • Regional Growth: The Asia Pacific region is anticipated to be a key driver of this growth.

Frequently Asked Questions (FAQs)

What is Viadur used for?

Viadur is indicated for the palliative treatment of advanced prostate cancer. It works by continuously delivering leuprolide acetate to reduce testosterone levels to castrate levels[1][4].

Why was Viadur discontinued?

Viadur's marketing was phased out due to diminished market demand and growing manufacturing costs, not due to safety or efficacy issues[2].

What are the common side effects of Viadur?

Common side effects include nocturia, urinary frequency, testis atrophy or pain, breast pain, and impotence. There is also a transient increase in serum testosterone during the first week of treatment, which can exacerbate symptoms[3].

How does Viadur work?

Viadur delivers leuprolide acetate continuously for 12 months, suppressing LH and FSH levels, which in turn reduces testosterone to castrate levels within 2 to 4 weeks after initiation of treatment[1][4].

What is the current market outlook for leuprorelin drugs?

The global leuprorelin drugs market is projected to grow from US$ 2.60 billion in 2023 to US$ 4.78 billion by 2034, with a CAGR of 5.7% from 2024 to 2034[5].

Sources:

  1. FDA Label for Viadur (leuprolide acetate implant) - accessdata.fda.gov
  2. FierceBiotech: Marketing of Viadur to Phase Out - fiercebiotech.com
  3. RxList: Viadur (Leuprolide Acetate Implant) - rxlist.com
  4. FDA Label for Viadur (leuprolide acetate implant) 2011 - accessdata.fda.gov
  5. Towards Healthcare: Leuprorelin Drugs Market - towardshealthcare.com

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