Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT04288427

Conditions

Benign Prostatic Hyperplasia

Prostate Hyperplasia

Prostate Disease

Prostate Hypertrophy

Prostate Pain

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Finasteride

Study Details

Brief summary:

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.

Conditions

Benign Prostatic Hyperplasia

Prostate Hyperplasia

Prostate Disease

Prostate Hypertrophy

Prostate Pain

Study ID

NCT04288427

Start date

Sep 25, 2020

Status verified date

Oct, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Finasteride Treatment

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.

Interventions

Finasteride

Patients who are candidates to receive 5ARI therapy, Finasteride, for clinical medical management of lower urinary tract symptoms will begin treatment once deemed eligible. They will be assess every 6 months for changes in urinary symptom scores and their responsiveness to the Finasteride treatment will be assessed at the 12-month time point. MRIs of prostate taken at the start of study and at the 3 year time point will assess prostate size and changes in size as well as degree of inflammatory changes. Gene expression of SRD5A2 as well as methylation pattern will be tested on prostate tissue samples, where hormonal androgen/estrogen levels will also be assessed as they are in blood samples.

Primary outcome measure

  • Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Yulia Mulugeta, BS

617-632-8890ymuluget@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Victoria Faustin, BA

617-632-1048vfaustin@bidmc.harvard.edu

Principal Investigator:

Aria Olumi, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Finasteride
  • 5 Alpha Reductase

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2025-10-28.