Radiation Oncology/Prostate/Screening and Prevention
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- Prostate Cancer Prevention Trial (1994-1997)
- 18,882 men, multicenter - enrolled men age 55 or older with normal DRE, PSA < 3.0, no medical comorbidities, and AUA score < 20. Randomized to finasteride 5 mg/day vs placebo x 7 yrs (planned). Pts followed with annual DRE and annual PSA. Planned end of study biopsy (min. 6 cores). Biopsy also recommended if abnormal DRE or PSA > 4.
- PSA values were adjusted for men in finasteride group (initially, adjusted PSA = 2.0 x PSA, but changed to 2.3 at man's fourth year); this was done to ensure a biopsy rate that is approximately equal between the groups.
- PMID 12824459, 2003 — "The influence of finasteride on the development of prostate cancer." Thompson IM et al. N Engl J Med. 2003 Jul 17;349(3):215-24.
- Study terminated early in 2003, 15 months before planned end of trial, due to study objective being met.
- Analysis based on 86.3% of pts who completed 7 yrs by the termination date. Prostate cancer status known (i.e. end of study biopsy completed or interval prostate cancer diagnosis) in 9989 pts (59.6% fin, 63.0% placebo). 9060 pts included in final analysis (excluding pts who had end of study biopsy performed late).
- Rate of prostate cancer diagnosis: 803(18.4%) F vs 1147(24.4%) P; risk reduction of 24.8%. 45-50% of prostate cancer was diagnosed at end of study biopsy rather than for increased PSA. High grade (Gleason score 7-10) in 280 of 757 graded tumors (37%) of F vs 237 of 1068 (22.2%) of P; RR = 1.67 for high grade.
- Treatment temporarily discontinued due to side effects in 18.3% of men in F group (vs 9.9% for P).
- Conclusion: Lowers the risk of prostate cancer by 24.8%. However, the finasteride group developed an increased proportion of patients with high grade tumors (Gleason 7-10).
