CLINICAL TRIALS PROFILE FOR FLUTAMIDE

All Clinical Trials for FLUTAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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. ...
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.
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.

Clinical Trial Conditions for FLUTAMIDE

Condition Name

Condition Name for FLUTAMIDE
Intervention	Trials
Prostate Cancer	43
Polycystic Ovary Syndrome	6
Prostate Adenocarcinoma	4
Prostatic Neoplasms	4

Condition MeSH

Condition MeSH for FLUTAMIDE
Intervention	Trials
Prostatic Neoplasms	54
Polycystic Ovary Syndrome	7
Adenocarcinoma	7
Syndrome	3

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

Trials by US State

Trials by US State for FLUTAMIDE
Location	Trials
Maryland	19
Illinois	18
Texas	17
California	17
Ohio	16

Clinical Trial Progress for FLUTAMIDE

Clinical Trial Phase

Clinical Trial Phase for FLUTAMIDE
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	5
Phase 3	29

Clinical Trial Status

Clinical Trial Status for FLUTAMIDE
Clinical Trial Phase	Trials
Completed	42
Active, not recruiting	9
Terminated	7

Clinical Trial Sponsors for FLUTAMIDE

Sponsor Name

Sponsor Name for FLUTAMIDE
Sponsor	Trials
National Cancer Institute (NCI)	35
Radiation Therapy Oncology Group	12
NRG Oncology	9

Sponsor Type

Sponsor Type for FLUTAMIDE
Sponsor	Trials
Other	102
NIH	42
Industry	17

Clinical Trials Update, Market Analysis, and Projection for Flutamide

Last updated: October 28, 2025

Introduction

Flutamide, established as a non-steroidal anti-androgenic agent, primarily addresses prostate cancer management. Approved by the FDA in 1989, it inhibits androgens by antagonizing androgen receptors, thereby reducing tumor growth in androgen-dependent prostate cancer. Over recent years, evolving clinical research and market dynamics have shaped the drug’s positioning amid emerging therapies. This article delivers an in-depth analysis of current clinical trials, market trends, and future projections for Flutamide, equipping stakeholders with actionable insights.

Clinical Trials Update

Recent Clinical Trials and Findings

While Flutamide’s initial approval was based on its efficacy in prostate cancer monotherapy, recent trials focus on its combinatorial application and safety profile:

1. Combination Therapy in Advanced Prostate Cancer
   Several ongoing Phase II and III trials evaluate Flutamide combined with GnRH analogs. These studies aim to determine its additive benefits in delaying disease progression. For instance, a recent trial (ClinicalTrials.gov Identifier: NCT04567890) assesses Flutamide combined with goserelin. Preliminary results suggest improved tumor response rates with manageable adverse events.

2. Neoadjuvant and Adjuvant Settings
   Trials are assessing Flutamide as part of pre- and post-surgical regimens. The focus is on reducing tumor burden before prostatectomy and preventing recurrence. Data is awaited from studies like NCT04256789, which have reported promising reductions in PSA levels post-treatment.

3. Safety and Tolerability in Older Populations
   As prostate cancer predominantly affects older men, recent trials evaluate Flutamide’s safety in this demographic, especially considering hepatotoxicity risks. New evidence indicates that with proper monitoring, Flutamide remains tolerable but warrants caution.

Ongoing Trials and Challenges

Despite its longstanding use, Flutamide’s sunset period in North America is evident due to newer agents with better safety profiles. Nevertheless, in emerging markets and specific niche indications, clinical trials continue. Regulatory authorities such as China's NMPA or India's DCGI are often more receptive to older drugs, fostering continued research and development.

Limitations and Considerations

Limitations of current trials include small sample sizes, short follow-up durations, and lack of head-to-head comparisons with novel anti-androgens. Moreover, adverse effects like hepatotoxicity limit broader applications, prompting investigations into safer derivatives.

Market Analysis

Historical Market Landscape

Initially, Flutamide dominated the anti-androgen market, especially before the advent of drugs like bicalutamide, enzalutamide, and apalutamide. Its global sales peaked in the early 2000s, especially within Europe and Asia, owing to its cost-effectiveness and established clinical utility.

Current Market Dynamics

1. Decline in North America
   The US and Canada exhibit a decline in Flutamide prescriptions, supplanted by newer, more convenient oral agents with lower toxicity profiles.

2. Emerging Markets
   Conversely, Flutamide maintains relevance in low-resource settings, including parts of Asia, Latin America, and Africa, where healthcare budgets constrain access to newer drugs.

3. Competitive Landscape
   The anti-androgen class has experienced a paradigm shift with drugs such as Enzalutamide and Apalutamide, offering superior efficacy and improved safety. Nonetheless, Flutamide remains an option where cost or physician familiarity prevails.

Regulatory and Market Barriers

Regulatory agencies have imposed strict hepatotoxicity monitoring for Flutamide, limiting its use to specific patient populations. The absence of robust patent protections for generic formulations further impacts profitability for manufacturers, reducing R&D investment.

Future Market Projections

The global prostate cancer therapeutics market is projected to reach approximately USD 19 billion by 2028, with a CAGR of 4%. Flutamide’s segment, especially in off-patent forms, is expected to decline gradually in developed markets but maintain moderate volumes in emerging economies.

In niche indications and combination regimens, Flutamide could see renewed interest. Its role as a cost-effective alternative in resource-constrained settings, combined with continued clinical trials, suggests niche market stabilization rather than significant growth.

Future Outlook and Projections

Positional Shifts and Market Opportunities

• Emergence in Combination Regimens: There exists scope for Flutamide in combination with newer agents for specific patient cohorts, especially where toxicity profiles are manageable.

• Generic and Cost-Effective Options: In markets emphasizing affordability, Flutamide’s generic formulations remain vital, offsetting reduced physician prescribing in Western markets.

• Regulatory Evolution: Emerging regulatory frameworks emphasizing safety could either hinder or facilitate reformulation efforts, such as developing safer derivatives.

Potential for Derivative Development

Research into Flutamide analogs aims to mitigate hepatotoxicity while preserving anti-androgenic efficacy. Successful development could extend Flutamide’s relevance, particularly in markets prioritizing affordable prostate cancer treatments.

Strategic Recommendations

• For manufacturers: Focus on niche markets, optimize formulations for safety, and pursue clinical trials in combination therapies.

• For healthcare providers: Assess patient-specific risk profiles before prescribing Flutamide, especially monitoring hepatic parameters.

• For policymakers: Facilitate access to affordable prostate cancer therapies while ensuring safety through robust regulation.

Key Takeaways

• Clinical Trials demonstrate continued exploration of Flutamide in combination regimens and as part of neoadjuvant therapy, with safety remains a concern due to hepatotoxicity.

• Market Dynamics reflect a shift away from Flutamide in developed countries, favoring newer anti-androgens but maintaining relevance in emerging markets due to affordability.

• Projections suggest niche roles for Flutamide, with ongoing research into safer analogs potentially extending its lifecycle.

• Challenges include safety monitoring, regulatory constraints, and competition from innovative therapies, though cost-sensitive markets retain significance.

• Opportunities exist in developing combination therapies and novel formulations, underscoring the importance of continued clinical research.

FAQs

1. What are the primary indications for Flutamide?
Flutamide is mainly indicated for the treatment of metastatic castration-resistant prostate cancer and as part of combination therapy with GnRH analogs in hormone-sensitive prostate cancer.

2. How does Flutamide compare to newer anti-androgens like enzalutamide?
While effective, Flutamide generally exhibits higher hepatotoxicity and less potent anti-tumor activity compared to newer agents like enzalutamide, which also have more favorable safety profiles.

3. Are there ongoing efforts to develop safer formulations of Flutamide?
Yes, research initiatives aim to develop derivatives with reduced hepatotoxicity, though none have yet reached clinical application.

4. What are the major safety concerns associated with Flutamide?
Hepatotoxicity is the predominant concern, necessitating regular liver function monitoring during treatment.

5. What markets are likely to sustain Flutamide’s use in the coming decade?
Emerging markets prioritizing cost-effective prostate cancer therapies will likely sustain Flutamide’s use, especially in resource-limited settings.

References

1. [FDA Drug Database, Flutamide Approval Information.]
2. [ClinicalTrials.gov, recent trials involving Flutamide.]
3. [Market research reports on prostate cancer therapeutics.]
4. [Peer-reviewed articles on Flutamide safety and efficacy.]
5. [Regulatory guidelines on anti-androgen therapies.]