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New treatment option for Benign Prostatic Hyperplasia
Official title 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
ClinicalTrials.gov ID: NCT04288427
What this study is testing
What is Finasteride?
Finasteride is an investigational medicine, being studied as a potential treatment for benign prostatic hyperplasia.
Also referred to as Sequential Time Point Study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.