RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-25
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04288427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male (physiological);
  2. * Age ≥ 50;
  3. * Eligible for treatment with 5ARI therapy;
  4. * Presence of lower urinary tract symptoms secondary to BPH;
  5. * Prostate size \>40cc by digital rectal examination;
  6. * Absence of prostate nodule, tenderness or firmness;
  7. * Mildly elevated PSA's \>1.5 ng/ml and ≤ 40 ng/ml;
  8. * Undergoing clinically indicated prostate biopsy for elevated prostate-specific antigen (PSA).
  1. * Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia);
  2. * Treatment with 5ARI (Finasteride or Dutasteride) within six months of study enrollment;
  3. * Current urinary tract infection;
  4. * Previous pelvic radiation;
  5. * Previous treatment with demethylating drugs;
  6. * Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, neurological deficits in the judgment of the investigator;
  7. * Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.

Contacts and Locations

Study Contact

Victoria Faustin, BA
CONTACT
617-632-1048
vfaustin@bidmc.harvard.edu

Principal Investigator

Aria F. Olumi, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Aria F. Olumi, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-25
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2020-09-25
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Finasteride
  • 5 Alpha Reductase

Additional Relevant MeSH Terms

  • Benign Prostatic Hyperplasia
  • Prostate Hyperplasia
  • Prostate Disease
  • Prostate Hypertrophy
  • Prostate Pain
  • Lower Urinary Tract Symptoms
  • Urinary Obstruction
  • Urinary Tract Disease