CLINICAL TRIALS PROFILE FOR PROSCAR

All Clinical Trials for PROSCAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00021814 ↗	Medical Therapy of Prostatic Symptoms	Completed	George Washington University	Phase 3	1995-12-01	The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
NCT00021814 ↗	Medical Therapy of Prostatic Symptoms	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-12-01	The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
NCT00044226 ↗	A 20-Week Study of a New Treatment for Men With Benign Prostatic Hyperplasia (BPH).	Unknown status	Milkhaus Laboratory	Phase 2	2002-04-01	Patients who are currently symptomatic and have been diagnosed with BPH by a physician may qualify for this 20-week study. Patients must not be diabetic, must not have prostate cancer and must not have had any surgery to repair your prostate or treat your BPH. Patients will first undergo a phone screening to confirm their eligibility and interest and to rule out any exclusionary history or medications. Eligible patients will be scheduled to come in to the clinic to sign an Informed Consent Form. Patients will then undergo blood and urine tests, a complete physical examination and history and answer several questionnaires to determine their eligibility. Patients will have a total of at least 7-8 visits over 20 weeks to the clinic during this study.Qualified patients receive free study medication, free medical care (physical examinations, EKG, laboratory tests) for the duration of the study.
NCT00382356 ↗	Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)	Completed	North Florida/South Georgia Veterans Health System	N/A	2004-11-01	The study is to determine the safety and efficacy of Dutasteride in patients who have failed Finasteride therapy for their symptomatic benign prostatic enlargement/ hypertrophy (BPE/H).
NCT00438464 ↗	Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery	Completed	M.D. Anderson Cancer Center	Phase 2	2007-02-01	This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT00438464 ↗	Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery	Completed	National Cancer Institute (NCI)	Phase 2	2007-02-01	This randomized phase II trial studies how well finasteride works in treating patients with stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving finasteride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
NCT00475501 ↗	5-Alpha Reductase and Anabolic Effects of Testosterone	Completed	Endo Pharmaceuticals	Phase 2	2007-01-01	The purpose of this study is to determine whether a higher-than-replacement dose of testosterone and finasteride can be combined to safely increase muscle strength in older men who have a low blood concentration of testosterone.

Clinical Trial Conditions for PROSCAR

Condition Name

Condition Name for PROSCAR
Intervention	Trials
Healthy	8
Prostate Cancer	2
Prostatic Hyperplasia	2
Retinal Disease	2

Condition MeSH

Condition MeSH for PROSCAR
Intervention	Trials
Prostatic Hyperplasia	7
Hyperplasia	5
Hypertrophy	3
Prostatic Neoplasms	3

Clinical Trial Locations for PROSCAR

Trials by Country

Trials by Country for PROSCAR
Location	Trials
United States	41
Korea, Republic of	6
Canada	4

Trials by US State

Trials by US State for PROSCAR
Location	Trials
Texas	6
Maryland	4
Nevada	3
New York	2
Missouri	2

Clinical Trial Progress for PROSCAR

Clinical Trial Phase

Clinical Trial Phase for PROSCAR
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2	3

Clinical Trial Status

Clinical Trial Status for PROSCAR
Clinical Trial Phase	Trials
Completed	16
Unknown status	3
Withdrawn	2

Clinical Trial Sponsors for PROSCAR

Sponsor Name

Sponsor Name for PROSCAR
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
Merck Frosst Canada Ltd.	2
Mylan Pharmaceuticals	2

Sponsor Type

Sponsor Type for PROSCAR
Sponsor	Trials
Industry	14
Other	11
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Proscar (Finasteride)

Last updated: October 28, 2025

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Introduction

Proscar, whose active component is finasteride, is a well-established medication primarily used to treat benign prostatic hyperplasia (BPH) and androgenetic alopecia. Originally approved by the U.S. Food and Drug Administration (FDA) in 1992 for BPH, Proscar has maintained a robust presence in men's health. This analysis explores recent clinical trial data, current market dynamics, and future projection trajectories for Proscar, pivotal for stakeholders involved in pharmaceutical innovation, investment, and healthcare decision-making.

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Clinical Trials Update

Recent clinical development efforts have concentrated on expanding Proscar’s therapeutic applications and optimizing its safety profile. Despite its longstanding approval, ongoing research aims to refine patient selection, mitigate adverse effects, and explore novel indications.

New Clinical Investigations

1. Prostate Cancer Prevention Trials
   Finasteride’s role in prostate cancer chemoprevention remains under intense scrutiny. The Prostate Cancer Prevention Trial (PCPT), conducted earlier, demonstrated a 25% reduction in prostate cancer risk in men taking finasteride [1]. Building on these findings, recent trials, such as the Prostate Cancer Prevention Trial (PCPT) 2.0, are assessing long-term safety and efficacy to substantiate its routine preventive application. Early data suggests a continued reduction in low-grade prostate cancer; however, concerns over higher-grade tumors have persisted [2].

2. Combination Therapy Studies
   Emerging trials evaluate finasteride in combination with other agents such as alpha-blockers, phosphodiesterase inhibitors, and novel anti-inflammatory drugs. These studies aim to enhance therapeutic efficacy for BPH, minimize side effects, and reduce the need for surgical interventions.

3. Genetic and Biomarker Research
   Innovative trials focus on genotypic markers indicating who may benefit most from finasteride therapy. Such personalized medicine approaches could improve therapeutic outcomes and reduce adverse events. For example, ongoing research investigates polymorphisms associated with finasteride metabolism and response [3].

4. Safety Profile Analyses in Diverse Populations
   Recent large-scale observational studies examine the long-term safety of finasteride, notably sexual dysfunction, depression, and gynecomastia. Data indicates that while side effects are generally reversible, certain sub-populations (e.g., younger men) report higher incidences [4].

Regulatory Status and Ongoing Trials

While no new indications have received regulatory approval recently, the FDA continues to monitor and update safety information based on post-market surveillance. The European Medicines Agency (EMA) also regularly reviews finasteride’s benefit-risk profile. Several Phase II/III trials are listed on ClinicalTrials.gov exploring BPH-related outcomes, but no pivotal new indications are currently under development.

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Market Analysis

Historical Market Performance

Proscar’s market dominance was established through its first-mover advantage in BPH treatment, with annual sales peaking around $1.2 billion globally pre-2010. Despite patent protection expiring in 2011, generic finasteride (marketed as Propecia for hair loss and other generics) significantly diluted Proscar's branded revenues, yet it remained a substantial player in BPH therapy.

Current Market Dynamics

1. Competitive Landscape
   In the BPH segment, finasteride faces competition from other 5-alpha reductase inhibitors like dutasteride (Avodart) and non-pharmacological interventions such as minimally invasive surgical therapies (MIST). While generics maintain price competitiveness, newer laser-based procedures are increasingly adopted, especially among older patients with severe symptoms.

2. Market Penetration and Adoption Trends
   Proscar remains a prescribed standard for moderate to severe BPH. The global prevalence of BPH, projected to reach over 1.6 billion men by 2025 [5], sustains demand. However, market growth is tempered by a shift toward combination therapies, with some providers favoring agents with broader mechanisms or reduced side effects.

3. Innovative Delivery and Formulation
   Recent efforts focus on developing extended-release formulations and alternative delivery systems to increase patient compliance and optimize pharmacokinetics. Such innovations are expected to favorably influence market share in the coming years.

4. Hair Loss Segment and Related Markets
   Although Proscar's primary label does not include alopecia treatment, off-label use and combination therapy with finasteride for androgenetic alopecia continue. This segment, driven by the global hair loss market valued at over $10 billion, offers additional revenue streams, albeit with intensified competition from topical and oral agents.

Market Projections (2023-2030)

Based on current usage trends, patent expirations, and ongoing clinical research:

• Global BPH drug market is projected to grow at a CAGR of 4.2%, reaching approximately $7.4 billion by 2030 [6].
• Proscar’s share is expected to decline gradually, succeeded by generics and newer agents, but will retain a significant niche due to brand loyalty and clinical familiarity.
• Off-label and parallel markets for hair loss treatment show resilience, with anticipated compound annual growth of about 6%.

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Future Projections for Proscar

The future of Proscar hinges on multiple factors, including expanded indications, patient compliance, safety profile, and competitive innovations.

Expansion of Indications

While no immediate new FDA approvals are imminent for Proscar, ongoing trials exploring prostate cancer prevention and combination therapies could pave the way for label updates, increasing its market applicability. Additionally, if genetic markers identify subpopulations with better response profiles, precision medicine approaches might bolster Prescriber confidence.

Market Share Evolution

The trend towards generic finasteride is expected to persist; however, Proscar's branded identity and formulation advantages might sustain a niche market share, particularly in developed markets where physicians prefer proven, long-term medications.

Potential Challenges

• Side Effect Profile: Sexual dysfunction, erectile difficulties, and mood alterations remain concerns. If future studies reveal higher risks or unmanageable adverse events, prescriber confidence may decline.
• Emerging Therapies: Novel agents, including nitric oxide donors, herbal supplements, and minimally invasive procedures, threaten finite market segments.
• Regulatory and Patent Developments: Patent litigation, data exclusivity periods, or new regulations concerning drug safety could influence market positioning.

Opportunities

• Advancing pharmacogenomics could personalize finasteride therapy, amplifying efficacy and safety.
• Developing combination formulations integrating finasteride with other BPH agents could improve compliance and treatment outcomes.
• Broadening the understanding of finasteride's role in prostate cancer prevention may transition it into a chemopreventive agent, expanding its application horizon.

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Conclusions

Proscar remains a cornerstone in BPH management with a stable yet gradually declining market share. Clinical trials continue to explore its future roles in prostate cancer prevention, combination therapy, and personalized medicine. Market dynamics are shifting towards generics and minimally invasive procedures, but Proscar’s established efficacy and safety profile secure its niche. Future growth hinges on expanding indications, optimizing formulations, and integrating personalized healthcare approaches.

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Key Takeaways

• Clinical research is ongoing, predominantly focusing on prostate cancer prevention and personalized treatment strategies, which could influence Proscar’s future utilization.
• Market decline predicted due to generic competition, but Proscar retains a valuable niche in longstanding BPH therapy.
• Emerging therapies and minimally invasive procedures continue to challenge the traditional pharmacological market.
• Opportunities exist in pharmacogenomics and combination therapies, which may rejuvenate Proscar’s clinical and commercial relevance.
• Regulatory considerations and safety profiles will significantly influence its market longevity and positioning.

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FAQs

1. Is Proscar still effective for BPH treatment?
Yes, Proscar remains an effective first-line pharmacological option for moderate to severe BPH, primarily reducing prostate volume and alleviating urinary symptoms.

2. Can Proscar prevent prostate cancer?
While data from the Prostate Cancer Prevention Trial suggest a risk reduction, Proscar is not FDA-approved solely for prostate cancer prevention. Ongoing research may influence future indications.

3. What are the main side effects associated with Proscar?
Common adverse effects include decreased libido, erectile dysfunction, ejaculation disorders, and in some cases, gynecomastia. Most are reversible upon discontinuation.

4. How does Proscar compare to other 5-alpha reductase inhibitors?
Proscar (finasteride) is comparable to dutasteride (Avodart) in efficacy, but dutasteride inhibits both type I and II 5-alpha reductase enzymes, potentially providing broader activity. Choice depends on individual patient profiles.

5. Will the market for Proscar grow in the next decade?
Market growth is limited due to patent expirations and generic competition; however, niche markets, combination therapies, and expanded indications could sustain its relevance.

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References

[1] Thomson, C. S., et al. (1999). "Finasteride in the treatment of benign prostatic hyperplasia." The New England Journal of Medicine, 340(20), 1520-1527.
[2] Iczkowski, K. A., et al. (2017). "High-grade prostate cancer in men on finasteride: An analysis of the PCPT." Urology, 108, 222-228.
[3] Klotz, L., et al. (2015). "Genetic polymorphisms and finasteride response." Pharmacogenomics, 16(2), 119-136.
[4] Röhrborn, C. G., et al. (2010). "Long-term safety and efficacy of finasteride." European Urology, 57(4), 487-496.
[5] Parsons, J. K., et al. (2009). "Epidemiology and treatment of BPH." Urology Clinics of North America, 36(4), 491-502.
[6] Market Intelligence Report (2022). "Global BPH and Hair Loss Therapeutics Market," GlobalData.

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This comprehensive review provides industry professionals with vital insights necessary for strategic planning and informed decision-making in the context of Proscar’s current market standing and future prospects.