Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010.
Theo Vos, Abraham D Flaxman, Mohsen Naghavi...
https://pubmed.ncbi.nlm.nih.gov/23245607Actively Recruiting
Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-28
120
Participants Needed
1
Research Sites
21 weeks
Total Duration
B
Beth Israel Deaconess Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
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
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Y
Yulia Mulugeta, BS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Theo Vos, Abraham D Flaxman, Mohsen Naghavi...
https://pubmed.ncbi.nlm.nih.gov/23245607Christopher S Saigal, Geoffrey Joyce
https://pubmed.ncbi.nlm.nih.gov/15758787Christopher R Chapple
https://pubmed.ncbi.nlm.nih.gov/15329091Aruna V Sarma, Debra J Jacobson, Michaela E McGree...
https://pubmed.ncbi.nlm.nih.gov/15879823J D McConnell, R Bruskewitz, P Walsh...
https://pubmed.ncbi.nlm.nih.gov/9475762John D McConnell, Claus G Roehrborn, Oliver M Bautista...
https://pubmed.ncbi.nlm.nih.gov/14681504Claus G Roehrborn, Igor Oyarzabal Perez, Erik P M Roos...
https://pubmed.ncbi.nlm.nih.gov/25565364Oliver M Bautista, John W Kusek, Leroy M Nyberg...
https://pubmed.ncbi.nlm.nih.gov/12689743Steven A Kaplan, Jeannette Y Lee, Alan G Meehan...
https://pubmed.ncbi.nlm.nih.gov/21334655Kai Wang, Dong-Dong Fan, Song Jin...
https://pubmed.ncbi.nlm.nih.gov/24457841