Table A2.
Characteristics for 5-ARI Studies
| Study (references) and Interventions (dose/d) | No. of Randomly Assigned Patients | Treatment Duration (years) | Baseline Demographic Characteristics | |
|---|---|---|---|---|
| Long-term trials (> 2 years) | ||||
| PCPT5 | 7 (± 90 days) | American men enrolled onto a prostate cancer prevention trial | ||
| Finasteride, 5 mg | 9,423 | Age, 45-64 years, 62%; ≥ 65 years, 38% | ||
| Placebo | 9,459 | Race/ethnicity: white, 92%; black, 3.8%; Hispanic, 2.6%; other, 1.5% | ||
| PSA (ng/mL), ≤ 3: 100% | ||||
| Family history of PCa (first-degree relative): 15.4% | ||||
| Mean baseline AUA/IPSS score: 6.7 (SD, 4.8) | ||||
| MTOPS10,33 | 4.5 | American men, mean age 62.6 (SD, 7.3), with LUTS secondary to BPH | ||
| Finasteride, 5 mg | 768 | Race/ethnicity: white, 82.3%; black, 8.9%; Hispanic, 7.3%; other, 1.5% | ||
| Doxazosin, 4-8 mg | 756 | Mean PSA (ng/mL): 2.4 (SD, 2.1) | ||
| Combination finasteride and doxazosin | 786 | Mean prostate volume (mL): 36.3 (SD, 20.1) | ||
| Placebo | 737 | Mean baseline AUA/IPSS score: 16.9 (SD, 5.9) | ||
| PLESS9,34–37 | 4.0 | American men, mean age 64 years (SD, 6.4), with LUTS secondary to BPH | ||
| Finasteride, 5 mg | 1,524 | Race: white 95.5% | ||
| Placebo | 1,516 | Mean PSA (ng/mL): 2.8 (SD, 2.1). | ||
| Mean baseline AUA/IPSS score: 15 (SD, 5.7). | ||||
| History of sexual dysfunction: 46% of men in each group at screening | ||||
| Moderate-term trials (1-2 years) | ||||
| ARIA/ARIB 3001, 3002, 30038,38–40 | 2.0 | Multinational men, mean age 66.3 years, with LUTS secondary to BPH (all participants had IPSS ≥ 12) | ||
| Dutasteride, 0.5 mg | 2,167 | Race/ethnicity: white, 92%; black, 4%; Hispanic, 7.3%; Asian, 1%; other, 1.5% | ||
| Placebo | 2,158 | Mean PSA (ng/mL): 4.0 (SD, 2.1) | ||
| Mean prostate volume (cm3): 54.5 | ||||
| Mean baseline AUA/IPSS score: 17.05 | ||||
| PROSPECT41 | 2.0 | Canadian men in good health, mean age, 63.3 years (range, 46 to 80 years) with LUTS secondary to BPH | ||
| Finasteride, 5 mg | 310 | Race: NR | ||
| Placebo | 303 | Mean PSA (ng/mL): NR | ||
| Mean baseline AUA/IPSS score: 16.2 | ||||
| PREDICT24 | 1.0 | European men, mean age, 64 years (range, 50 to 80 years), with LUTS secondary to BPH (all participants had IPSS ≥ 12) | ||
| Finasteride, 5 mg | 264 | Race: NR | ||
| Doxazosin, 4-8 mg | 275 | Mean PSA (ng/mL): 2.6 | ||
| Combination finasteride and doxazosin | 286 | Mean prostate volume (g): 36 | ||
| Placebo | 270 | Mean baseline AUA/IPSS score: 17.2 | ||
| VA Coop (Johnson, 2003; a subset of subjects from Lepor 1996)25,42 | 1.0 | American men, mean age 65 years, with symptomatic BPH | ||
| Finasteride, 5 mg | 252 | Race: white 80% | ||
| Terazosin, 10 mg | 262 | Race/ethnicity (from Lepor): white, 87%; black, 11%; Asian, 1%; Native American, 0.5% | ||
| Combination finasteride and terazosin | 272 | Mean PSA (from Lepor; ng/mL): 2.3 | ||
| Placebo | 254 | Mean prostate volume (g): 37.6 | ||
| Mean baseline AUA/IPSS score: 16.1 | ||||
| Foley, 200022 | 1.0 | British men, mean age, 77.5 years (range, 55 to 89 years), with hematuria associated with BPH | ||
| Finasteride, 5 mg | 29 | Race: NR | ||
| Watchful waiting | 28 | Mean PSA (ng/mL): NR | ||
| Mean baseline AUA/IPSS score: NR | ||||
| Cote, 199843 | 1.0 | American men age ≥ 50 years (mean, 68 years) with elevated PSA (> 4.0 ng/mL); study objective was to examine effect of finasteride on prostate cellular proliferation and high-grade PIN | ||
| Observation (watchful waiting) | 29 | Race: NR | ||
| Finasteride, 5 mg | 29 | Mean PSA (ng/mL): 9.8 | ||
| Mean baseline AUA/IPSS score: NR | ||||
| Pre-existing high-grade PIN: observation, 5 men; Finasteride, 8 men | ||||
| FSG44–48 | American and international men; mean age, 64.9 years (range, 40 to 83 years) with BPH | |||
| Finasteride, 1 mg | 547 | Race/ethnicity: white, 95.8%; black, 1.6%; other, 2.6%. | ||
| Finasteride, 5 mg | 543 | Mean PSA (ng/mL): 4.7 | ||
| Placebo | 555 | Mean prostate volume (cm3): 55.0 | ||
| Mean baseline AUA/IPSS score: NR | ||||
| Short-term trials (< 1 year) | ||||
| ARIA 200149 | 0.5 | American and Canadian men age ≥ 50 years (mean, 62.6 to 65.5 years across groups), with LUTS secondary to BPH; study objective was to examine effect of dutasteride on serum dihydrotestosterone levels | ||
| Dutasteride, 0.01, 0.05, 0.5, 2.5, and 5 mg | 285 | Race: NR | ||
| Finasteride, 5 mg | 55 | Mean PSA (ng/mL): NR | ||
| Placebo | 59 | Mean baseline AUA/IPSS score: NR | ||
| MICTUS50 | 0.5 | Italian men, mean age, 63 years (SD, 7.1 years), with LUTS secondary to BPH (all participants had IPSS ≥ 13) | ||
| Finasteride, 5 mg | 204 | Race: NR | ||
| Tamsulosin, 0.4 mg | 199 | Mean PSA (ng/mL): NR | ||
| Mean baseline AUA/IPSS score: NR | ||||
| Lee, 200251 | Korean men, mean age, 64.7 years, with LUTS secondary to BPH (all participants had Korean IPSS > 8) | |||
| Finasteride, 5 mg | 102 | Race: Asian, 100% | ||
| Tamsulosin, 0.2 mg | 103 | Mean PSA (ng/mL): 2.0 | ||
| Mean prostate volume (cm3): 29.8 | ||||
| Mean baseline AUA/IPSS score: 19.5 |
Abbreviations: 5-ARI, 5-α-reductase inhibitor; PCPT, Prostate Cancer Prevention Trial; PSA, prostate-specific antigen; PCa, prostate cancer; AUA/IPSS, American Urological Association/International Prostate Symptom Score; SD, standard deviation; NR, not reported; MTOPS, Medical Therapy of Prostatic Symptoms; LUTS, lower urinary tract symptoms; BPH, benign prostatic hyperplasia; PLESS, Proscar Long-Term Efficacy and Safety Study; SD, standard deviation; NR, not reported; PREDICT, Prospective European Doxazosin and Combination Therapy; PIN, prostatic intraepithelial neoplasia; FSG, Finasteride Study Group; MICTUS, Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms.