Finasteride for Enlarged Prostate

Overseen By Yulia Mulugeta, BS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some men with an enlarged prostate, or Benign Prostatic Hyperplasia (BPH), do not respond to the medication Finasteride. Researchers aim to predict which patients might not benefit from Finasteride by using MRI scans to detect inflammation in the prostate. Men experiencing BPH symptoms, such as frequent urination, with a prostate size greater than 40cc and undergoing a prostate biopsy, might be suitable candidates. Participants will take Finasteride and attend regular check-ups to monitor the treatment's effectiveness over time. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving BPH treatment.

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.

Is there any evidence suggesting that Finasteride is likely to be safe for humans?

Research shows that Finasteride is generally safe for treating an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Studies have found that it can improve symptoms over the long term and lower the chance of needing surgery. For many people, Finasteride helps reduce urinary problems caused by an enlarged prostate.

However, some side effects have been reported, including a possible increased risk of a serious type of prostate cancer. Discussing this risk with a doctor is important. While many people handle Finasteride well, individual reactions can differ.

Overall, Finasteride is considered well-tolerated for most people with BPH, and the benefits often outweigh the risks. Always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for enlarged prostate, which often include medications like alpha-blockers and other 5-alpha reductase inhibitors, Finasteride targets the 5-alpha reductase enzyme more specifically. Researchers are excited about Finasteride because it not only reduces prostate size but also potentially impacts gene expression and hormonal levels linked to prostate enlargement. This dual action could mean more effective symptom management and deeper insights into the biological changes in the prostate, offering hope for better long-term outcomes.

What is the effectiveness track record for Finasteride in treating Benign Prostatic Hyperplasia (BPH)?

Research has shown that Finasteride, which participants in this trial will receive, effectively treats Benign Prostatic Hyperplasia (BPH), a condition that causes an enlarged prostate. Studies indicate that it can shrink the prostate by 22% and improve urine flow, reducing issues like difficulty urinating. One study found that taking 5 mg of Finasteride daily significantly eases symptoms of blockage. Using Finasteride for six years has demonstrated lasting improvements in urinary symptoms and prostate size. Overall, Finasteride generally provides a reliable option for managing BPH symptoms. ^{3 5 6 7 8}

Who Is on the Research Team?

Aria Olumi, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2710385/

Finasteride in the treatment of patients with benign ... Results were in agreement with the North American Finasteride Trial, demonstrating a prostate volume reduction of 22% (P < 0.001), increased peak flow rate by ...

2. nejm.org nejm.org/doi/full/10.1056/NEJM199210223271701

The Effect of Finasteride in Men with Benign Prostatic ... The treatment of benign prostatic hyperplasia with 5 mg of finasteride per day results in a significant decrease in symptoms of obstruction.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1335066/

Efficacy and safety of finasteride therapy for benign ... OUTCOME MEASURES: Efficacy: changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume. Safety: onset, course and resolution of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429502025487

Long-term 6-year experience with finasteride in patients ... Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug- ...

5. mdpi.com mdpi.com/1648-9144/61/11/1944

Comparative Effectiveness and Safety of Finasteride ... Results: Both treatment groups demonstrated significant within-group improvements in LUTS severity and urodynamic outcomes (p < 0.001 for IPSS, Qmax, and QoL).

6. mayoclinic.org mayoclinic.org/drugs-supplements/finasteride-oral-route/description/drg-20063819

Finasteride (oral route) - Side effects & dosage This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429598006669

Efficacy of finasteride is maintained in patients with benign ... Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9610579/

Long-term effects of finasteride in patients with benign ... Conclusions: Finasteride causes long-term symptomatic improvement and reduces the risk of acute urinary retention or surgery. Men with enlarged prostates ...