KEY TAKEAWAYS
- The Phase 3 study examined if elevated serum testosterone and DHT levels correlate with the emergence of LUTS in asymptomatic men and the worsening of LUTS in symptomatic men.
- The study reported that elevated levels of serum testosterone and DHT did not correlate with LUTS onset in asymptomatic men or LUTS progression in symptomatic men.
In older males, Benign Prostatic Hyperplasia (BPH) is frequently seen and often leads to lower urinary tract symptoms (LUTS), which can negatively impact their quality of life. The causes of BPH are not fully understood; earlier theories suggested a link to elevated androgen levels, although existing data do not unanimously support this view. This study investigated whether high levels of serum testosterone and dihydrotestosterone (DHT) are linked to the onset of LUTS in men without symptoms and the progression of LUTS in those already affected.
Researchers conducted a supplementary analysis of the REDUCE study involving 3009 asymptomatic men with baseline International Prostate Symptom Score (IPSS) <8 and 2145 symptomatic men with baseline IPSS ≥ 8 who were not using α-blockers or 5α-reductase inhibitors. The REDUCE trial was initially designed to examine the preventative effects of dutasteride on prostate cancer in men with elevated PSA levels and a negative biopsy before the study. Over 4 years, IPSS was monitored every 6 months.
Using Cox models, researchers assessed the relationship between various levels of serum testosterone and DHT at the study’s outset with the incidence and progression of LUTS. For men without symptoms, first-time medical treatments, surgeries, or sustained significant symptoms determined new occurrences of LUTS. For symptomatic men, LUTS progression was marked by a ≥ 4-point increase in IPSS from baseline, any BPH-related surgery, or a new BPH medication initiation.
The study reported that neither elevated serum testosterone nor DHT levels were associated with LUTS onset in asymptomatic men or LUTS progression in symptomatic men (all p values were above the respective thresholds). The data were not influenced by dutasteride treatment.
Higher serum levels of testosterone and DHT were unrelated to the occurrence or progression of LUTS, thus not supporting the theory that elevated androgen levels in middle-aged men contribute to LUTS.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003219.06
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT00056407
Daniels, James; Mirocha, James; Moreira, Daniel; Andriole, Gerald; Freedland, Stephen. PD02-06 SERUM TESTOSTERONE AND DIHYDROTESTOSTERONE AND INCIDENCE AND PROGRESSION OF LOWER URINARY TRACT SYMPTOMS IN REDUCTION BY DUTASTERIDE OF PROSTATE CANCER EVENTS TRIAL, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003219.06
