📃 Paper Title: The Influence of Finasteride on the Development of Prostate Cancer
🧍 Author: Thompson
🕒 Year: 2003
📚 Journal: The New England Journal of Medicine (NEJM)
🌎 Country: USA
ㅤContext to the study:
Which trial compared finasteride to placebo in prostate cancer patients for 7 years?
ㅤ✅ Take-home message of study:
In the Prostate Cancer Prevention Trial, over 18,000 patients without prostate cancer were randomised to receive finasteride or placebo for seven years.
Finasteride (5mg daily) resulted in a 24.8% relative risk reduction in the prevalence of prostate cancer at 7 years.
High grade disease (Gleason 7 to 10) was noted in a higher proportion of the finasteride group (6.4%) compared to the placebo group (5.1%).
ㅤ Multi-centre, randomised controlled trial
221 study sites
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Study participants:
Total randomised: 18,882 (finasteride: n= 9,423; placebo: n= 9,459)
Inclusion criteria:
Age 55
Normal digital rectal examination
PSA 3.0 ng/mL
AUA symptom score < 20
Prostate biopsy was recommended if annual PSA level (adjusted for finasteride) was >4.0ng/mL or annual digital rectal examination was abnormal. All men (not already diagnosed with prostate cancer) were offered an end-of-study prostate biopsy.
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Key study outcomes:
Primary outcome: Prevalence of prostate cancer at 7 years follow-up:
Finasteride group: 18.4%
Placebo group: 24.4%
This equates to relative risk reduction of 24.8%
Secondary outcomes (selected): Prevalence of "high-grade" disease (Gleason 7-10):
Finasteride group: 6.4%
Placebo group: 5.1%
When considered in terms of the proportion of confirmed prostate cancer:
Finasteride group: 37.0% of tumours were "high grade"
Placebo group: 22.2% of tumours were "high grade"
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Study Limitations:
Patients in the placebo group were offered to undergo investigation for prostate cancer (prostate biopsy) at a significantly higher rate than the finasteride group (24.8% vs 22.5%, p<0.001)
The rates of non-adherence (% days of treatment missed) were 14.7% for the finasteride group and 10.8% in the placebo group
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