5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
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|ClinicalTrials.gov Identifier: NCT04288427|
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment|
|Benign Prostatic Hyperplasia Prostate Hyperplasia Prostate Disease Prostate Hypertrophy Prostate Pain Lower Urinary Tract Symptoms Urinary Obstruction Urinary Tract Disease||Drug: Finasteride|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy|
|Actual Study Start Date :||September 25, 2020|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||April 2025|
Patients who are eligible will be given 5ARI therapy, Finasteride, for medical management of Benign Prostatic Hyperplasia (BPH) symptoms. Only patients with lower urinary tract symptoms (LUTS) as assessed by AUA urinary symptom score > than 8, (suggestive of moderate LUTS) prostate size > 40cc, no prostate nodule/tenderness/firmness and increased PSA between 4-10ng/ml requiring prostate biopsy will be enrolled. Then, they will have prostate MRIs/needle biopsies and blood/urine collection followed by treatment with Finasteride (standard of care). They will be followed in urology clinic for assessment of LUTS every 6 months and Finasteride responsiveness at the 12-month time point. Prostate biopsy samples will be evaluated for SRD5A2 gene expression/methylation, hormonal androgen/estrogen levels (which will be repeated in blood samples). Prostate MRIs will assess size/inflammatory changes at the start and 3-year time points.
Patients who are candidates to receive 5ARI therapy, Finasteride, for clinical medical management of lower urinary tract symptoms will begin treatment once deemed eligible. They will be assess every 6 months for changes in urinary symptom scores and their responsiveness to the Finasteride treatment will be assessed at the 12-month time point. MRIs of prostate taken at the start of study and at the 3 year time point will assess prostate size and changes in size as well as degree of inflammatory changes. Gene expression of SRD5A2 as well as methylation pattern will be tested on prostate tissue samples, where hormonal androgen/estrogen levels will also be assessed as they are in blood samples.
Other Name: Sequential Time Point Study
- Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score [ Time Frame: Assessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months. ]Validated questions of the AUA Urinary Symptom Score will be used every 6 months to assess efficacy of Finasteride treatment in improving lower urinary tract symptoms in the patient population. Based on previous randomized trials, it will be determined whether the patient is responsive or resistant to the treatment dependent on changes in their AUA Urinary Symptom Score at the first 12 month mark. For patients who are resistant to Finasteride, other medical or surgical treatments will be offered, and the patients will be removed from the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288427
|Contact: Justin Chimoffemail@example.com|
|Contact: Christopher Mistretta, RNfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Chris Mistretta, RN 978-821-0889 email@example.com|
|Contact: Justin Chimoff, B.S. 617-632-1048 firstname.lastname@example.org|
|Principal Investigator: Aria Olumi, MD|
|Principal Investigator:||Aria F. Olumi, MD||Beth Israel Deaconess Medical Center|