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Last Updated: January 15, 2025

CLINICAL TRIALS PROFILE FOR FLUTAMIDE


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All Clinical Trials for flutamide

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00001521 ↗ Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1995-06-08 This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density. ...
NCT00002633 ↗ Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed Eastern Cooperative Oncology Group Phase 3 1995-02-08 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 whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗ Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed Medical Research Council Phase 3 1995-02-08 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 whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗ Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1995-02-08 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 whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002597 ↗ Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1994-10-01 RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00002597 ↗ Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer Completed Radiation Therapy Oncology Group Phase 3 1994-10-01 RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00001266 ↗ A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma Completed National Cancer Institute (NCI) Phase 2 1990-10-01 One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. Survival was less in patients with high rather than low circulating androgen levels. Thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. In this trial, we will pilot this concept.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for flutamide

Condition Name

426440051015202530354045Prostate CancerPolycystic Ovary SyndromeProstate AdenocarcinomaProstatic Neoplasms[disabled in preview]
Condition Name for flutamide
Intervention Trials
Prostate Cancer 42
Polycystic Ovary Syndrome 6
Prostate Adenocarcinoma 4
Prostatic Neoplasms 4
[disabled in preview] 0
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Condition MeSH

53770-50510152025303540455055Prostatic NeoplasmsPolycystic Ovary SyndromeAdenocarcinomaSyndrome[disabled in preview]
Condition MeSH for flutamide
Intervention Trials
Prostatic Neoplasms 53
Polycystic Ovary Syndrome 7
Adenocarcinoma 7
Syndrome 3
[disabled in preview] 0
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Clinical Trial Locations for flutamide

Trials by Country

+
Trials by Country for flutamide
Location Trials
United States 564
Canada 60
Japan 17
Australia 6
France 4
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Trials by US State

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Trials by US State for flutamide
Location Trials
Maryland 19
Illinois 18
Texas 17
California 17
Ohio 16
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Clinical Trial Progress for flutamide

Clinical Trial Phase

7.1%41.4%48.6%005101520253035Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for flutamide
Clinical Trial Phase Trials
Phase 4 5
Phase 3 29
Phase 2/Phase 3 2
[disabled in preview] 34
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Clinical Trial Status

57.7%12.7%9.9%19.7%0510152025303540CompletedActive, not recruitingTerminated[disabled in preview]
Clinical Trial Status for flutamide
Clinical Trial Phase Trials
Completed 41
Active, not recruiting 9
Terminated 7
[disabled in preview] 14
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Clinical Trial Sponsors for flutamide

Sponsor Name

trials05101520253035National Cancer Institute (NCI)Radiation Therapy Oncology GroupNRG Oncology[disabled in preview]
Sponsor Name for flutamide
Sponsor Trials
National Cancer Institute (NCI) 35
Radiation Therapy Oncology Group 12
NRG Oncology 9
[disabled in preview] 20
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Sponsor Type

60.9%26.9%10.9%00102030405060708090100OtherNIHIndustry[disabled in preview]
Sponsor Type for flutamide
Sponsor Trials
Other 95
NIH 42
Industry 17
[disabled in preview] 2
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Clinical Trials, Market Analysis, and Projections for Flutamide

Introduction to Flutamide

Flutamide, marketed under the brand name Eulexin, is a nonsteroidal antiandrogen primarily used in the treatment of prostate cancer. It works by blocking the action of androgens (male hormones) which are involved in the growth and spread of prostate cancer cells.

Current Clinical Trials and Research

While there are no recent clinical trials specifically focused on flutamide as a standalone treatment, it is often used in combination with other therapies. For instance, the concept of combining antiandrogen therapy with androgen deprivation therapy (ADT) is well-established in the treatment of prostate cancer. A similar approach is seen in the study of darolutamide, another antiandrogen, which highlights the efficacy of combining these therapies in treating non-metastatic castration-resistant prostate cancer (nmCRPC)[1].

Market Analysis of Flutamide

Global Market Size and Forecast

The global market for flutamide, although not as prominently highlighted as other antiandrogens, is part of the broader nonsteroidal antiandrogen market. The global cyproterone acetate market, which includes other antiandrogens, is expected to grow significantly from 2024 to 2032. While specific figures for flutamide are not provided, the overall market for antiandrogens is anticipated to see considerable growth due to increasing demand for effective treatments in oncology and other related conditions[2].

Regional Demand and Market Dynamics

The demand for flutamide and other antiandrogens varies by region, with significant growth expected in areas with high incidence rates of prostate cancer. The U.S. clinical trials market, which includes oncology segments, is a key indicator of the growing demand for innovative cancer treatments. The oncology segment accounted for the maximum revenue share of 27% in 2023 and is expected to register the fastest CAGR over the forecast period[3].

Key Players and Market Competition

The market for flutamide is competitive, with several pharmaceutical companies involved in the production and distribution of antiandrogen drugs. While flutamide itself may not be as widely studied or marketed as newer antiandrogens like darolutamide, it remains a viable treatment option. The leading key players in the broader antiandrogen market include major pharmaceutical companies that invest heavily in research and development to enhance their product portfolios[2].

Medical Necessity and Usage

Treatment Indications

Flutamide is considered medically necessary for the treatment of adults with unresectable locally advanced or metastatic prostate cancer. It is often used in combination with other therapies such as ADT to enhance treatment efficacy. The drug is also considered for other conditions, such as cholangiocarcinoma with specific genetic rearrangements, although these uses are less common[4].

Dosage and Administration

The typical dosage of flutamide involves 250 mg taken three times a day. The drug is usually administered orally and is part of a comprehensive treatment plan that may include other medications and therapies[4].

Market Projections

Growth Rate and Forecast

The global market for antiandrogens, including flutamide, is expected to grow at a significant rate over the next decade. The CAGR for the broader cyproterone acetate market, which includes flutamide, is anticipated to be substantial, driven by increasing demand for effective cancer treatments and advancements in healthcare[2].

Future Developments and Opportunities

The future of flutamide and other antiandrogens looks promising, driven by ongoing research in oncology and the need for innovative treatments. The U.S. clinical trials market, for example, is expected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, with the oncology segment leading the growth. This trend indicates a favorable environment for the development and marketing of antiandrogen drugs like flutamide[3].

Challenges and Restraints

Regulatory and Safety Considerations

Clinical trials, including those involving flutamide, are rigorously regulated by bodies like the FDA to ensure patient safety and data integrity. While these regulations are crucial, they can also pose challenges in terms of time and cost for drug development and approval[3].

Competition from Newer Therapies

The market for antiandrogens is competitive, with newer drugs like darolutamide gaining prominence. These newer therapies may offer improved efficacy and safety profiles, potentially impacting the market share of older drugs like flutamide[1].

Key Takeaways

  • Market Growth: The global market for antiandrogens, including flutamide, is expected to grow significantly over the next decade.
  • Clinical Use: Flutamide remains a viable treatment option for prostate cancer and other conditions, often used in combination with ADT.
  • Regulatory Environment: Clinical trials are heavily regulated, ensuring safety and efficacy but also presenting challenges in drug development.
  • Competition: The market is competitive, with newer antiandrogens potentially impacting the market share of older drugs like flutamide.
  • Future Developments: Ongoing research in oncology and the need for innovative treatments drive the future prospects of flutamide and other antiandrogens.

FAQs

What is flutamide used for?

Flutamide is primarily used in the treatment of prostate cancer, particularly for unresectable locally advanced or metastatic cases. It can also be used for other conditions like cholangiocarcinoma with specific genetic rearrangements.

How does flutamide work?

Flutamide works by blocking the action of androgens (male hormones) which are involved in the growth and spread of prostate cancer cells.

What is the typical dosage of flutamide?

The typical dosage of flutamide involves 250 mg taken three times a day.

Is flutamide still used in modern cancer treatment?

Yes, flutamide is still used, although it may be less prominent than newer antiandrogens like darolutamide. It is often used in combination with other therapies such as ADT.

What are the potential side effects of flutamide?

Common side effects include liver toxicity, diarrhea, and hot flashes. It is important to monitor liver function during treatment.

How does the market for flutamide compare to other antiandrogens?

The market for flutamide is part of the broader antiandrogen market, which is expected to grow significantly. However, newer antiandrogens may gain more market share due to their improved efficacy and safety profiles.

Sources

  1. Bayer Clinical Trials Explorer: "Prostate Cancer | Study 20963 | Bayer - Clinical Trials Explorer"
  2. Wicz: "Flutamide Market 2024: In-Depth Size, Share, and Regional Demand Analysis to 2032"
  3. Biospace: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033"
  4. Premera: "Miscellaneous Oncology Drugs" (PDF)
  5. Market Research Reports: "Global Flutamide Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030"

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