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Treatment for symptom-detected early prostate CA effective in pts younger than 65

Clinical Question:
Does early surgery improve outcomes in men with symptom-detected early prostate cancer?

Bottom Line:
In this group of patients with symptom-detected early prostate cancer, treatment of those younger than 65 years decreased all-cause mortality (absolute risk reduction = 6.6% over 13 years). No clear benefit was seen for men older than 65 years, and we do not know if any benefit would be seen in asymptomatic men with cancer detected via screening. (LOE = 1b)

Bill-Axelson A, Holmberg L, Ruutu M, et al, for the SPCG-4 Investigators. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2011;364(18):1708-1717.  [PMID:21542742]

Study Design:
Randomized controlled trial (nonblinded)



Inpatient (any location) with outpatient follow-up

This study enrolled 695 men with localized prostate cancer that had been newly diagnosed between 1989 and 1999 on the basis of symptoms (prostate-specific antigen [PSA] levels were not routinely measured in Sweden at the time). All the men were younger than 75 years; had at least a 10-year life expectancy; a T0, T1, or T2 cancer with no evidence of bony metastasis; a PSA level of less than 50 ng/mL; and well-differentiated or a moderately well-differentiated tumor. The men were randomized to receive either radical prostatectomy or watchful waiting. Local recurrences in surgery patients and metastatses in any patient were treated with hormonal therapy, while obstructive symptoms in the watchful waiting group were treated with transurethral resection of prostate. The preoperative Gleason scores were compared with postoperative Gleason scores by pathologists masked to the initial assignments, with more than half the patients actually having a higher (more aggressive) Gleason score than originally assigned. The mean age of participants was 65 years, with a mean PSA of 13 ng/mL, and a median follow-up of 13 years. The cumulative all-cause mortality rate was lower in the radical prostatectomy group (46.1% vs 52.7%; P = .007; number needed to treat [NNT] = 15). The prostate specific mortality was also lower (14.6% vs 20.7%; P = .01; NNT = 16), as was the likelihood of distant metastases (21.7% vs 33.4%; P < .001; NNT = 8). Several subgroup analyses were performed, and the results indicated no significant difference in outcomes for men with PSA values less than versus greater than 10 ng/mL, or with Gleason scores less than versus greater than 7. More than one third of men who were randomized to the watchful waiting group required no therapy.


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