CLINICAL TRIALS PROFILE FOR PROSCAR

All Clinical Trials for PROSCAR

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

Clinical Trial Conditions for PROSCAR

Condition Name

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

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−

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

Trials by US State

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−

Trials by US State for PROSCAR
Location	Trials
Texas	6
Maryland	4
Nevada	3
Illinois	2
Colorado	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

Proscar (Finasteride): Clinical Trials, Market Analysis, and Projections

Introduction to Proscar (Finasteride)

Proscar, known generically as finasteride, is a 5α-reductase inhibitor used primarily for the treatment of symptomatic benign prostatic hyperplasia (BPH) and androgenetic alopecia (male pattern baldness). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Prostate Specific Antigen (PSA) and Prostate Cancer Detection

Clinical studies have shown that Proscar significantly reduces serum PSA concentration by approximately 50% within six months of treatment. This reduction is predictable across the entire range of PSA values in patients with symptomatic BPH, although individual variations may occur[1][3].

Prostate Cancer Prevention Trial (PCPT)

The PCPT, a 7-year randomized, double-blind, placebo-controlled trial, was designed to determine if finasteride could prevent prostate cancer in men aged 55 and older. The trial, which enrolled 18,882 men, was stopped early in 2003 when it was found that finasteride reduced the risk of developing prostate cancer by 25%. Further analysis in 2013 indicated a 30% reduction in prostate cancer risk (10.5% in the finasteride group versus 14.9% in the placebo group)[4].

Adverse Reactions and Safety Profile

The PLESS study, a 4-year placebo-controlled clinical trial, evaluated the safety of Proscar in 1524 patients. The most frequently reported adverse reactions were related to sexual function, with 3.7% of patients treated with Proscar discontinuing therapy due to these side effects, compared to 2.1% in the placebo group[1][3].

Breast Cancer and Other Safety Concerns

There have been rare cases of breast cancer reported in men treated with finasteride. For example, the PCPT and PLESS studies noted a few cases of breast cancer in both treatment and placebo groups, but no significant increase in risk was associated with finasteride[1][3].

Market Analysis

Current Market Size and Growth

As of 2024, the finasteride market was valued at approximately USD 122.88 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of around 2.7% to 2.8% from 2025 to 2037. By 2037, the market is projected to reach USD 159.01 million[2][5].

Growth Drivers

• Increasing Prevalence of BPH and Prostate Cancer: The rising cases of benign prostatic hyperplasia and prostate cancer, particularly among the aging population, drive the demand for finasteride. For instance, in 2021, about 248,530 new cases of prostate cancer were estimated in the United States, with 6 in 10 cases occurring in men aged 65 or older[2].
• Growing Demand for Hair Treatment: The increasing incidence of androgenetic alopecia among men also contributes to the market growth. Emerging economies and the rising consumer spending on hair treatment products further boost the market[2][5].
• Research and Development: Ongoing research and development activities in the pharmaceutical industry, including new indications and formulations, are expected to provide additional growth opportunities[2].

Market Segmentation

The finasteride market is segmented by application into prostate treatment, hair treatment, and others. The prostate treatment segment is anticipated to hold the largest share due to the rising cases of BPH[2].

Distribution Channels

The market is also segmented by distribution channels, including hospital pharmacies, online pharmacies, and retail pharmacies. The emergence of online pharmacies as a convenient and private option for patients is expected to influence market growth[5].

Projections and Future Outlook

Market Projections

By 2037, the finasteride market is expected to reach USD 159.01 million, driven by the increasing demand for treatments of BPH and androgenetic alopecia. The CAGR of around 2.7% to 2.8% indicates a steady growth trajectory over the forecast period[2][5].

Emerging Trends

• Online Pharmacies: The growing preference for online pharmacies due to convenience and privacy is likely to continue, influencing the distribution channel dynamics of the finasteride market[5].
• Research and Development: Continued research into new indications and formulations of finasteride could expand its market reach and applications[2].

Challenges and Opportunities

• Adverse Reactions: The potential for sexual dysfunction and other adverse reactions may impact patient compliance and market growth. However, these risks are generally well-managed with proper medical supervision.
• Competition: The presence of other 5α-reductase inhibitors, such as dutasteride, and potential new entrants in the market could pose competition. However, finasteride's established brand and efficacy profile are likely to maintain its market position[3][5].

Key Takeaways

• Clinical Efficacy: Proscar significantly reduces PSA levels and has been shown to reduce the risk of prostate cancer by up to 30%.
• Market Growth: The finasteride market is expected to grow steadily, driven by increasing cases of BPH and androgenetic alopecia.
• Distribution Trends: Online pharmacies are emerging as a significant distribution channel.
• Research and Development: Ongoing R&D activities are expected to provide new growth opportunities.

FAQs

Q: What is the primary use of Proscar (finasteride)?

A: Proscar is primarily used for the treatment of symptomatic benign prostatic hyperplasia (BPH) and androgenetic alopecia (male pattern baldness).

Q: How does Proscar affect PSA levels?

A: Proscar reduces serum PSA concentration by approximately 50% within six months of treatment, which is predictable across the entire range of PSA values in patients with symptomatic BPH[1][3].

Q: Did the Prostate Cancer Prevention Trial (PCPT) show any significant results?

A: Yes, the PCPT showed that finasteride reduced the risk of developing prostate cancer by 25% to 30% in men aged 55 and older[4].

Q: What are the common adverse reactions associated with Proscar?

A: The most frequently reported adverse reactions are related to sexual function, including impotence, decreased libido, and ejaculation disorder[1][3].

Q: What is the projected market size of finasteride by 2037?

A: The finasteride market is expected to reach approximately USD 159.01 million by 2037, growing at a CAGR of around 2.7% to 2.8%[2][5].

Sources

1. PROSCAR® (finasteride) Tablets - FDA Label[1]
2. Finasteride Market Size & Share, Growth Report 2037 - Research Nester[2]
3. Proscar: Package Insert / Prescribing Information - Drugs.com[3]
4. Prostate Cancer Prevention Trial (PCPT): Questions and Answers - National Cancer Institute[4]
5. Finasteride Market Size, Competitors & Forecast to 2030 - Research and Markets[5]