Raloxifene + Finasteride for Enlarged Prostate
(BPH Management Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining finasteride (a medication that reduces hormone levels to shrink the prostate) with raloxifene (a selective estrogen receptor modulator) can more effectively treat enlarged prostate (benign prostatic hyperplasia or BPH) in men who do not respond well to finasteride alone. Researchers hope this combination can target different pathways responsible for prostate growth and benefit more patients. Men advised by their doctor to use finasteride for BPH and who have a recent PSA test (a prostate health check) under 20 ng/ml might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of potentially more effective BPH therapies.
Will I have to stop taking my current medications?
The trial requires you to keep taking any current genitourinary medications, like beta agonists, alpha blockers, or anticholinergics.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that finasteride is generally safe and effective for treating benign prostatic hyperplasia (BPH), a condition affecting the prostate. One study found that it reduced BPH symptoms, suggesting it can provide relief without major safety concerns. However, some reports indicate a slight increase in the risk of serious prostate cancer, though this increase was not significant.
Raloxifene, a medication often used for osteoporosis in women, is being tested with finasteride. While specific safety information about this combination for men with BPH is limited, raloxifene is known to be safe in its usual applications.
This trial is in an early stage, so while some information appears promising, the complete safety of using finasteride and raloxifene together is still under investigation. Participants might experience mild to moderate side effects, and the trial aims to better understand these effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Raloxifene with Finasteride for treating an enlarged prostate because this approach introduces a fresh mechanism of action. While Finasteride is commonly used to shrink the prostate by blocking hormones that cause growth, adding Raloxifene, which is a selective estrogen receptor modulator, could potentially offer additional benefits by influencing estrogen pathways. This combination could enhance symptom relief and possibly slow disease progression more effectively than Finasteride alone. This innovative strategy might offer a more comprehensive treatment option for managing an enlarged prostate.
What evidence suggests that this trial's treatments could be effective for enlarged prostate?
Research has shown that finasteride, a common treatment for an enlarged prostate (BPH), can greatly reduce symptoms like difficulty urinating. Finasteride blocks a substance that causes the prostate to grow. In this trial, participants may be randomized into the Finasteride + Raloxifene Combination Therapy arm. Raloxifene, typically used for bone health, is being studied to determine if it can enhance the effects of finasteride. Early research suggests that combining raloxifene with finasteride might offer a new treatment approach for BPH, particularly for those who do not experience sufficient relief from finasteride alone. This combination aims to address different causes of prostate growth, offering hope for better symptom control.13567
Who Is on the Research Team?
Aria Olumi, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for men newly diagnosed with benign prostatic hyperplasia (BPH), experiencing moderate to severe lower urinary tract symptoms, and have a PSA level below 10ng/ml. Men must not have prostate nodules or abnormal firmness/tenderness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Finasteride + Raloxifene or Finasteride + Placebo for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Finasteride
- Raloxifene
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator