Identifying patients who may not respond to Finasteride for prostate issues

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

This study is trying to find out why some men with prostate issues don’t get better with Finasteride, so they can identify those patients early and explore other treatment options.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 50 Years and up
• Sex: Male
• Sponsor: Beth Israel Deaconess Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04288427 on ClinicalTrials.gov

What this trial studies

This study aims to understand why some men with Benign Prostatic Hyperplasia (BPH) do not respond to the treatment drug Finasteride. By utilizing noninvasive techniques such as MRI, the researchers hope to detect inflammation in the prostate, which may help predict treatment resistance. The goal is to identify patients who are unlikely to benefit from Finasteride before they start the medication, allowing for alternative treatment options to be considered. This could improve patient outcomes and reduce unnecessary treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 50 and older who have lower urinary tract symptoms due to BPH and are eligible for 5ARI therapy.

Not a fit: Patients with a diagnosis of prostate cancer or those who have recently been treated with 5ARI medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better treatment strategies for men with BPH by identifying those who will not respond to Finasteride.

How similar studies have performed: While there have been studies on BPH treatments, this approach of using MRI to predict resistance to Finasteride is relatively novel.

Eligibility criteria

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.

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Aria F. Olumi, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Yulia Mulugeta, BS

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