Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
NCT04288427

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

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

120

Participants Needed

1

Research Sites

322 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

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

Official 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 treatment with 5-alpha reductase inhibitor therapy
  • Presence of lower urinary tract symptoms caused by benign prostatic hyperplasia
  • Prostate size larger than 40cc by digital rectal examination
  • No prostate nodules, tenderness, or firmness
  • Mildly elevated prostate-specific antigen (PSA) between 1.5 and 40 ng/ml
  • Undergoing a clinically indicated prostate biopsy due to elevated PSA
Not Eligible

You will not qualify if you...

  • Diagnosis of any prostate cancer or precancerous prostate lesions
  • Treatment with 5-alpha reductase inhibitors (Finasteride or Dutasteride) within 6 months before enrollment
  • Current urinary tract infection
  • Previous pelvic radiation therapy
  • Previous treatment with demethylating drugs
  • Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, or other neurological deficits
  • Unable or unwilling to undergo 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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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

CONTACT

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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