Finasteride for Enlarged Prostate

Overseen By Victoria Faustin, BA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: 5ARI, Demethylating drugs

Disqualifiers: Prostatic malignancy, Urinary infection, Neurological deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 12 months

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia (BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find ways to predict which patients will not respond to Finasteride so that, in the future, these patients can be identified prior to offering this treatment and they can be offered alternative treatment strategies in its place. The aim is to see if noninvasive techniques such as MRI can detect inflammation of the prostate to assist with early detection of those who will and who will not respond to Finasteride.

Will I have to stop taking my current medications?

The trial requires that you have not taken Finasteride or Dutasteride (medications for prostate issues) within six months before joining. Other medications are not mentioned, so it's best to discuss with the trial team.

What evidence supports the effectiveness of the drug finasteride for treating an enlarged prostate?

Research shows that finasteride can significantly reduce prostate size and improve urinary symptoms in men with an enlarged prostate. It decreases levels of a hormone called dihydrotestosterone (DHT), which helps reduce prostate volume and improve urinary flow. ^{1 2 3 4 5}

Is finasteride safe for humans?

Finasteride is generally considered safe for humans, with studies showing it is well-tolerated for treating enlarged prostate. However, some men have reported sexual side effects, such as erectile dysfunction, which may persist even after stopping the medication. ^{3 6 7 8 9}

How does the drug finasteride differ from other treatments for an enlarged prostate?

Finasteride is unique because it specifically inhibits the enzyme 5-alpha reductase, reducing the conversion of testosterone to dihydrotestosterone (DHT), which is a key factor in prostate growth. This mechanism helps decrease prostate size and improve urinary symptoms, offering a non-surgical alternative with minimal side effects compared to other treatments. ^{1 4 7 10 11}

Research Team

Aria Olumi, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Men over 50 with an enlarged prostate (BPH) and urinary symptoms who haven't had certain treatments like Finasteride recently. They should have a mildly elevated PSA level, no prostate nodules or tenderness, and be able to undergo an MRI. Those with neurological conditions, past pelvic radiation, current UTI, or previous cancerous prostate lesions can't join.

Inclusion Criteria

Your PSA level is between 1.5 and 40 ng/ml.

I am a biological male.

I am eligible for 5-alpha-reductase inhibitor therapy.

Exclusion Criteria

I have a urinary tract infection right now.

Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.

I have been diagnosed with a type of prostate cancer or precancerous prostate condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Finasteride for medical management of BPH symptoms, with prostate MRIs/needle biopsies and blood/urine collection

12 months

Clinic visits every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessment of LUTS and Finasteride responsiveness

3 years

Prostate MRIs at start and 3-year time points

Treatment Details

Interventions

• Finasteride

Trial Overview The trial is studying why some men with BPH don't respond to Finasteride. It's testing if MRI scans can identify inflammation in the prostate that might predict non-response to the drug so alternative treatments can be offered sooner.

Participant Groups

Group I: Finasteride Treatment Experimental Treatment 1 Intervention

Patients who are eligible will be given 5ARI therapy, Finasteride, for medical management of Benign Prostatic Hyperplasia (BPH) symptoms. Only patients with lower urinary tract symptoms (LUTS) as assessed by American Urologic Association (AUA) urinary symptom score \> than 8, (suggestive of moderate LUTS) prostate size \> 40cc, no prostate nodule/tenderness/firmness and increased PSA between 4-10ng/ml requiring prostate biopsy will be enrolled. Then, they will have prostate MRIs/needle biopsies and blood/urine collection followed by treatment with Finasteride (standard of care). They will be followed in urology clinic for assessment of LUTS every 6 months and Finasteride responsiveness at the 12-month time point. Prostate biopsy samples will be evaluated for SRD5A2 gene expression/methylation, hormonal androgen/estrogen levels (which will be repeated in blood samples). Prostate MRIs will assess size/inflammatory changes at the start and 3-year time points.

Finasteride is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Propecia for:

• Benign prostatic hyperplasia
• Male pattern baldness

Approved in European Union as Proscar for:

• Benign prostatic hyperplasia
• Male pattern baldness

Approved in Canada as Finasteride for:

• Benign prostatic hyperplasia
• Male pattern baldness

Approved in Japan as Finasteride for:

• Benign prostatic hyperplasia
• Male pattern baldness

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Finasteride significantly reduces levels of dihydrotestosterone by 70% to 80% and decreases prostate gland size by 15% to 25%, particularly benefiting patients with larger prostates, leading to improved urinary flow and symptom relief.

Long-term use of finasteride can alter the progression of benign prostatic hyperplasia (BPH), reducing the rates of acute urinary retention and the need for surgery, while showing no difference in prostate cancer detection rates compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5alpha-reductase inhibitors: what role should they play? Kaplan, SA.[2019]

Finasteride effectively reduces levels of the hormone DHT, leading to a 20% reduction in prostate size and a 50% decrease in PSA levels, providing moderate improvement in urinary flow and symptoms for patients with benign prostatic hypertrophy (BPH).

While Finasteride is generally safe for treating BPH, it can cause side effects such as impotence in 3% of patients and decreased ejaculatory volume, but it is also effective in preventing bleeding associated with BPH and can help stop male baldness in younger men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finasteride in the treatment of benign prostatic hypertrophy: an update. New indications for finasteride therapy. Ekman, P.[2019]

In a study of 1,645 patients with benign prostatic hyperplasia (BPH) over 12 months, finasteride significantly reduced serum dihydrotestosterone levels by 60-80% and prostate volume by 20%.

Patients experienced improved urinary flow rates and reduced obstructive urinary symptoms, with these benefits being well maintained throughout the study, and finasteride demonstrated a good safety profile with high tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finasteride for the treatment and control of benign prostatic hyperplasia: summary of phase III controlled studies. The Finasteride Study Group. Grino, P., Stoner, E.[2019]

In a long-term study of 186 men with benign prostatic hyperplasia (BPH), finasteride 5 mg effectively reduced prostate volume by 22.7% and improved urinary symptoms over 5 years, demonstrating sustained efficacy.

Finasteride was well tolerated throughout the study, with no significant increase in sexual side effects, indicating its safety for long-term use in treating BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. The North American Finasteride Study Group. Hudson, PB., Boake, R., Trachtenberg, J., et al.[2022]

Finasteride selectively lowers dihydrotestosterone (DHT) levels in the prostate and scalp without affecting testosterone levels, which helps maintain muscle strength, bone density, and sexual function.

Long-term studies indicate that finasteride can effectively halt the progression of benign prostatic hyperplasia (BPH), and it shows potential for use in preventing prostate cancer and treating male pattern baldness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finasteride: a clinical review. Gormley, GJ.[2019]

In a 4-year study involving 3040 men with benign prostatic hyperplasia, finasteride 5 mg was associated with a higher incidence of sexual adverse experiences (AEs) during the first year of treatment (15% vs. 7% for placebo), indicating a temporary increase in sexual side effects.

By years 2 to 4, the incidence of new sexual AEs was similar between the finasteride and placebo groups (7% each), suggesting that the initial side effects may resolve over time while continuing therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. Wessells, H., Roy, J., Bannow, J., et al.[2022]

Finasteride (5 mg daily) significantly reduces prostate volume, dihydrotestosterone (DHT), and prostate-specific antigen (PSA) levels while improving maximum urinary flow rates and symptom scores in patients with benign prostatic hyperplasia (BPH) after 12 months of treatment.

Long-term data from an open-label extension study involving approximately 543 patients indicate that finasteride is well-tolerated and maintains its efficacy in treating symptomatic BPH over a continuous 3-year period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5alpha-reductase inhibitors/finasteride. Stoner, E.[2013]

In a study of 71 healthy men aged 21-46 who experienced new-onset sexual side effects after taking finasteride for male pattern hair loss, 94% reported low libido and 92% reported erectile dysfunction, with symptoms persisting for an average of 40 months after stopping the medication.

The findings highlight the importance of discussing the risk of persistent sexual side effects with patients considering finasteride, as the average duration of use was 28 months and significant declines in sexual function were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent sexual side effects of finasteride for male pattern hair loss. Irwig, MS., Kolukula, S.[2022]

In a study involving 298 men with benign prostatic hyperplasia, finasteride (5 mg) significantly reduced prostate volume by 25% over 24 months, with 60% of patients experiencing a reduction of 20% or more.

Finasteride demonstrated long-term safety and tolerability, with the most common side effects being decreased libido and ejaculation disorders, affecting more than 1% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. Stoner, E.[2013]

Long-term treatment with proskar (finasteride) for benign prostatic hyperplasia (BPH) showed a high response rate of 93.8-95.8% among 428 patients, indicating its efficacy in managing this condition.

The treatment duration should be at least 12 months, and side effects were infrequent, affecting only a small percentage of patients (5.1% libido, 5.6% erection, and 4.2% ejaculate volume), suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of the effectiveness of long-term treatment of patients with benign prostatic hyperplasia]. Tkachuk, VN., Al'-Shukri, SKh., Luk'ianov, AE.[2013]

In a study of 23 men over 3 years, finasteride significantly reduced levels of dihydrotestosterone (DHT) and prostate-specific antigen (PSA), leading to a 25% decrease in prostate volume after one year.

While finasteride improved urination by increasing flow rates and reducing residual urine, the overall symptom relief was mild, and the drug was noted for its lack of side effects, suggesting it could be a safe alternative to surgery for benign prostatic hypertrophy (BPH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Finasteride (Proscar) for benign prostatic hypertrophy]. Matzkin, H., Chen, J., Braf, Z.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

5alpha-reductase inhibitors: what role should they play? [2019]

2. England pubmed.ncbi.nlm.nih.gov

Finasteride in the treatment of benign prostatic hypertrophy: an update. New indications for finasteride therapy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Finasteride for the treatment and control of benign prostatic hyperplasia: summary of phase III controlled studies. The Finasteride Study Group. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. The North American Finasteride Study Group. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Finasteride: a clinical review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

5alpha-reductase inhibitors/finasteride. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Persistent sexual side effects of finasteride for male pattern hair loss. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. [2013]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Results of the effectiveness of long-term treatment of patients with benign prostatic hyperplasia]. [2013]

11. Israel pubmed.ncbi.nlm.nih.gov

[Finasteride (Proscar) for benign prostatic hypertrophy]. [2013]