Back to search results
NCT04288427

5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy

Recruiting
NAAges 50+InterventionalTreatment
Beth Israel Deaconess Medical Center
~120 participants
Updated 2025-10-28 on ClinicalTrials.gov
What's tested:Finasteride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score
Measured over Assessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months.

Conditions

Benign Prostatic Hyperplasia
Prostate Hyperplasia
Prostate Disease
Prostate Hypertrophy
Prostate Pain
Lower Urinary Tract Symptoms
Urinary Obstruction
Urinary Tract Disease

Explore related trials

Benign Prostatic HyperplasiaLower Urinary Tract SymptomsKLK3 Gene

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Aria F. Olumi, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Yulia Mulugeta, BS
[email protected]
617-632-8890
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Male (physiological);
Age ≥ 50;
Eligible for treatment with 5ARI therapy;
Presence of lower urinary tract symptoms secondary to BPH;
Prostate size \>40cc by digital rectal examination;
Absence of prostate nodule, tenderness or firmness;
Mildly elevated PSA's \>1.5 ng/ml and ≤ 40 ng/ml;
Undergoing clinically indicated prostate biopsy for elevated prostate-specific antigen (PSA).

Exclusion

Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia);
Treatment with 5ARI (Finasteride or Dutasteride) within six months of study enrollment;
Current urinary tract infection;
Previous pelvic radiation;
Previous treatment with demethylating drugs;
Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, neurological deficits in the judgment of the investigator;
Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.

What this trial measures

  • Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom scoreAssessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months.

    Validated questions of the AUA Urinary Symptom Score will be used every 6 months to assess efficacy of Finasteride treatment in improving lower urinary tract symptoms in the patient population. Based on previous randomized trials, it will be determined whether the patient is responsive or resistant to the treatment dependent on changes in their AUA Urinary Symptom Score at the first 12 month mark. For patients who are resistant to Finasteride, other medical or surgical treatments will be offered, and the patients will be removed from the study.