Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Approved in 4 jurisdictions
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.
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.
1251011How 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.
35689What 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.
24678Will 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.
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
I am a biological male.
I am eligible for 5-alpha-reductase inhibitor therapy.
My prostate is larger than normal as determined by a physical exam.
I am 50 years old or older.
My prostate does not have any lumps, pain, or hardness.
I have urinary problems due to an enlarged prostate.
I am having a prostate biopsy due to high PSA levels.
Exclusion Criteria
I have a urinary tract infection right now.
I have been diagnosed with a type of prostate cancer or precancerous prostate condition.
I have had radiation therapy to my pelvic area before.
I have been treated with drugs that affect DNA methylation.
I have taken Finasteride or Dutasteride in the last 6 months.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Finasteride TreatmentExperimental Treatment1 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:
πΊπΈ Approved in United States as Propecia for:
- Benign prostatic hyperplasia
- Male pattern baldness
πͺπΊ Approved in European Union as Proscar for:
- Benign prostatic hyperplasia
- Male pattern baldness
π¨π¦ Approved in Canada as Finasteride for:
- Benign prostatic hyperplasia
- Male pattern baldness
π―π΅ Approved in Japan as Finasteride for:
- Benign prostatic hyperplasia
- Male pattern baldness
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Maintenance of clinical efficacy with finasteride therapy for 24 months in patients with benign prostatic hyperplasia. The Finasteride Study Group. [2013]Finasteride, a 5 alpha-reductase inhibitor, has been shown to have beneficial effects in the treatment of benign prostatic hyperplasia. The long-term safety and efficacy of finasteride in the treatment of benign prostatic hyperplasia was assessed.
Finasteride for the treatment and control of benign prostatic hyperplasia: summary of phase III controlled studies. The Finasteride Study Group. [2019]The efficacy and safety profiles of finasteride were tested in 1,645 patients with benign prostatic hyperplasia (BPH) over a 12-month period. The following effects were observed: (1) a 60-80% reduction in serum dihydrotestosterone levels; (2) a 20% reduction in prostate volume; (3) significant increases in the maximum urinary flow rate compared with placebo; and (4) significant improvement in urinary symptoms, particularly obstructive symptoms. All effects were well maintained for the entire duration of the study. Finasteride had a good safety profile and was well tolerated.
[Finasteride (Proscar) for benign prostatic hypertrophy]. [2013]Several alternatives to surgery for benign prostatic hypertrophy (BPH) were studied during the past few years. Finasteride (Proscar), a 4-azosteroid, is an inhibitor of the enzyme 5-alpha reductase, which is responsible for the conversion of testosterone to the biologically more active dihydrotestosterone (DHT). We report 3 years of experience with the drug in 23 men. Persistent significant decreases in serum DHT and prostate-specific antigen (PSA) were documented. Prostatic volume decreased by about 25% after 1 year, and remained fairly constant thereafter. Urination improved, as evidenced by increased maximal flow rate and decreased volume of residual urine. Symptoms were affected favorably, but only mildly. One of the main advantages of the drug is its lack of side-effects. More data on a larger number of patients with a longer follow-up are needed before finasteride can be established as having a role as an alternative treatment for BPH.
Finasteride: a clinical review. [2019]Finasteride is the first of a new class of 5 alpha-reductase inhibitors which allows selective androgen deprivation affecting dihydrotestosterone (DHT) levels in target organs such as the prostate and scalp hair without effecting circulating levels of testosterone thus preserving the desired androgen mediated effects on muscle strength, bone density and sexual function. Finasteride has been demonstrated to produce significant effects in men with an enlarged prostate gland. The long-term data now emerging suggests that progression of benign prostatic hyperplasia (BPH) may be arrested providing additional long term benefits. Experimental uses in prostate cancer prevention and male pattern baldness offer new and exciting possibilities for this class of compounds.
5alpha-reductase inhibitors/finasteride. [2013]Benign prostatic hyperplasia (BPH) is a disease diagnosed by the presence of prostatic enlargement and lower-tract urinary obstruction. Finasteride (Proscar), is a potent and specific inhibitor of 5alpha-reductase, which inhibits the conversion of testosterone (T) to dihydrotestosterone (DHT) an important promoter of prostatic growth. It has provided a new therapeutic alternative for the treatment of BPH. The safety and efficacy of finasteride in the treatment of symptomatic BPH have been demonstrated by two multi-center placebo-controlled studies. After 12 months of treatment with 5 mg finasteride daily, prostate volume, DHT and prostate-specific antigen (PSA) levels were reduced and maximum urinary flow rates and symptom scores were improved. Finasteride was well-tolerated. Upon completion of the controlled studies, patients were eligible to enter an open-label extension study in which all patients received 5 mg finasteride. Approximately half of the 543 patients randomized to the 5 mg finasteride group in the controlled studies have now been treated with 5 mg finasteride continuously for 3 years. The data provided by this group of patients on the long-term safety and efficacy of finasteride in the treatment of symptomatic BPH are reviewed.
Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. The North American Finasteride Study Group. [2022]The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH).
Finasteride in the treatment of benign prostatic hypertrophy: an update. New indications for finasteride therapy. [2019]A phenomenon of the prostate gland, which is also shared by hair follicles, is that it is little influenced by testosterone (T) for androgenic stimulation, but instead by its metabolite 5alpha-dihydrotestosterone (DHT). By blocking the conversion of T to DHT, the circulating level of DHT is reduced by 80%, the size of the prostate gland is reduced by about 20% and the level of prostate-specific antigen (PSA) by about 50%. Treatment of patients with obstructive benign prostatic hypertrophy (BPH) with the drug Finasteride leads to a moderately improved urinary flow, symptomatic improvement and halts the natural progress of the disease. Since DHT potentiates the effect of testosterone on erectile function, the side-effects are impotence in 3% of patients, decreased ejaculatory volume, and gynaecomastia in 0.4% of patients. The drug could be regarded as a safe way to treat moderately symptomatic BPH. The efficacy of the drug is long-lasting (more than 7 years). It has also been tried in prostate cancer, but is less effective. It reduces PSA levels by 50% and, in combination therapy, therefore, PSA levels remain low for longer when Finasteride is added. An important finding is the efficacy of Finasteride treatment in haematuria from BPH. The drug interacts with vascular endothelium growth factor and efficiently prevents new bleeding. It could be regarded as a first-line therapy for this type of haematuria. Finasteride can also be used to stop male baldness. It seems particularly effective in men aged 20-40 years; 85% of patients stopped losing hair when given Finasteride. When the treatment was stopped hair loss continued, thus therapy may have to be "lifelong".
5alpha-reductase inhibitors: what role should they play? [2019]The development of finasteride (PROSCAR, Merck & Co., Whitehouse Station, NJ) for the treatment of benign prostatic hyperplasia (BPH) has had variable results. Numerous short-term and long-term studies comparing finasteride with placebo have been reported. The results suggest that, physiologically, treatment with finasteride significantly decreases levels of both serum and intraprostatic dihydrotestosterone about 70% to 80% from baseline. In addition, total gland size decreases significantly-about 15% to 25% from baseline-particularly in the area of the periurethral zone of the prostate after finasteride treatment. Baseline prostate size has been found to have a relation to efficacy of finasteride treatment. The larger the prostate at baseline, the greater the urinary flow rate increase and symptom score decrease compared with placebo. Health-related quality-of-life parameters improved in those taking finasteride. In studies evaluating combination therapy, no significant differences were noted between those treated with an alpha blocker, such as terazosin or doxazosin in combination with finasteride, and those receiving an alpha blocker alone. Long-term finasteride versus placebo studies, such as the PROSCAR Long-Term Efficacy and Safety Study (PLESS), suggest that long-term medical therapy with finasteride affects the natural history of the disease as manifested by the decrease in rates of acute urinary retention and surgery. In patients who are "therapeutic responders," the degree of symptomatic improvement in those treated with finasteride appears to be equal to that seen in patients receiving alpha blockers. Prostate cancer detection rates did not differ between those treated with finasteride and those receiving a placebo. The results of these studies suggest that physicians must evaluate what role finasteride plays in the spectrum of available options for the treatment of BPH and lower urinary tract symptoms. Baseline parameters, such as prostate volume, prostate-specific antigen values, and whether to administer finasteride in combination with alpha blockers, are among the factors that will determine the appropriateness of such therapy.
[Results of the effectiveness of long-term treatment of patients with benign prostatic hyperplasia]. [2013]A long-term proskar (finasterid, MSD) treatment was given to 428 patients with benign prostatic hyperplasia (BPH). The response was achieved in 93.8-95.8% patients. The duration of the course should be at least 12 months. Side effects were rare: libido, erection, ejaculate volume diminished in 5.1, 5.6 and 4.2% patients, respectively. 20 patients were operated on after proskar therapy. Such pretreatment reduced glandular prostatic tissue.
Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. [2022]To evaluate the incidence and resolution of sexual adverse experiences (AEs) in men with benign prostatic hyperplasia treated with finasteride 5 mg compared with placebo.
Persistent sexual side effects of finasteride for male pattern hair loss. [2022]Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that "persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use."