Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
ID04288427

5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy for Benign Prostatic Hyperplasia

Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-28

120

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male (physiological)
  • Age 50 years or older
  • Eligible for 5ARI therapy treatment
  • Presence of lower urinary tract symptoms due to BPH
  • Prostate size greater than 40cc by digital rectal exam
  • No prostate nodule, tenderness, or firmness
  • Mildly elevated PSA levels between 1.5 and 40 ng/ml
  • Undergoing prostate biopsy due to elevated PSA
Not Eligible

You will not qualify if you...

  • Diagnosis of prostate cancer or precancerous lesions
  • Treatment with 5ARI drugs (Finasteride or Dutasteride) within 6 months prior to enrollment
  • Current urinary tract infection
  • Previous pelvic radiation therapy
  • Previous treatment with demethylating drugs
  • Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, or neurological deficits
  • Unable or unwilling to have MRI due to implants, claustrophobia, or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants who are eligible will begin treatment with Finasteride for management of benign prostatic hyperplasia symptoms. They will have prostate MRIs and biopsies, and blood and urine samples collected to assess gene expression, methylation patterns, and hormone levels.

Clinic visits every 6 months with assessment of urinary symptoms; MRI at start and 3 years

Follow-up

Duration - Up to 3 years

Participants will be monitored for changes in prostate size and symptom improvement with an MRI at the 3-year time point to assess long-term effects and inflammatory changes.

1 MRI visit at 3 years

Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

Y

Yulia Mulugeta, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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