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Screening for Prostate Cancer (continued)
Table 1. Summary of Evidence
| Studies (n) and Overall Quality | Limitations | Consistency | Applicability to Screening Population | Summary of Findings |
|---|---|---|---|---|
| KQ 1. Does PSA-based screening decrease prostate cancer–specific or all-cause mortality? | ||||
| 5 RCTs
Overall quality: fair |
Only 2 fair-quality RCTs; 1 additional fair-quality report from a center participating in 1 of the RCTs with substantial population overlap | Low (inconsistent results between highest-quality trials) | Some screening practices (interval and PSA thresholds) were different from typical U.S. practice | PSA-based screening identifies more prostate cancers, but most trials found no effect on risk for death from prostate cancer. However, the 2 largest and highest-quality trials reported conflicting results. The ERSPC trial found PSA screening every 2–7 y to be associated with decreased risk for death from prostate cancer in a prespecified subgroup of men aged 55–69 y after 9 y (RR, 0.80 [95% CI, 0.65–0.98]; absolute risk reduction, 0.07 percentage point), but the PLCO trial found no effect after 10 y (RR, 1.1 [CI, 0.80–1.5]).
The PLCO trial had a relatively high rate of previous PSA testing (44%) and contamination in the control group (50% received ≥1 PSA test). The ERSPC trial varied in recruitment and randomization procedures, screening intervals, and PSA cut points among study centers. There were greater use of active treatments and more frequent screening intervals in the PLCO trial than the ERSPC trial. A fair-quality study from 1 center participating in the ERSPC trial reported better results than the overall ERSPC analysis, with substantial overlap in patient populations. Three poor-quality screening trials did not find PSA-based screening to be associated with decreased risk for death from prostate cancer. |
| KQ 2. What are the harms of PSA-based screening for prostate cancer? | ||||
| 2 RCTs
Overall quality: fair |
Randomized evidence available only from 2 fair-quality trials | High | Some screening practices (interval and PSA thresholds) differed from typical U.S. practice | Reports from 2 fair-quality trials found false-positive rates of 12%–13% after 3–4 rounds of PSA-based screening, and 1 trial found that 76% of prostate biopsies identified no cancer. Serious infections or urine retention occurred after 0.5%–1.0% of prostate biopsies. Evidence was insufficient to estimate the magnitude of psychological harms associated with false-positive PSA test results. |
| KQ 3. What are the benefits of treatment of early-stage or screening-detected prostate cancer? | ||||
| Prostatectomy | ||||
| 10 studies:
2 RCTs; 8 cohort studies
Overall quality: fair |
Only 1 RCT | High | Prostate cancers in the RCT were primarily clinically detected rather than screening-detected, and there was a high proportion of stage T2 cancers; limited information was provided on specific surgical techniques evaluated | Prostatectomy was associated with decreased risk for prostate cancer–specific mortality (RR, 0.62 [CI, 0.44–0.87]; absolute difference, 6.1 percentage points [CI, 0.2–12 percentage points]) and all-cause mortality (RR, 0.75 [CI, 0.61–0.92]; absolute difference, 6.6 percentage points [CI, -1.3 to 14 percentage points]) compared with watchful waiting after 15 y of follow-up in 1 good-quality RCT. Subgroup analysis suggests benefits are limited to men <65 y. Observational studies also found prostatectomy to be associated with decreased risk for death from prostate cancer (6 studies; median adjusted HR, 0.46 [range, 0.32–0.67]) and all-cause mortality (5 studies; median adjusted HR, 0.32 [range, 0.25–0.50]) after 4–13 y of follow-up compared with watchful waiting. |
| Radiation therapy | ||||
| 5 cohort studies
Overall quality: fair |
No RCTs | High | Limited information provided on specific radiation therapy techniques and regimens evaluated | Radiation therapy was associated with decreased risk for prostate cancer–specific mortality (5 studies; median adjusted HR, 0.66 [range, 0.63–0.70]) and all-cause mortality (5 studies; median adjusted HR, 0.68 [range, 0.62–0.81]) after 4–13 y of follow-up compared with watchful waiting. |
| KQ 4. What are the harms of treatment of early-stage or screening-detected prostate cancer? | ||||
| Prostatectomy | ||||
| 18 studies: 1 RCT; 11 cohort studies; 6 uncontrolled observational studies Overall quality: fair |
Only 1 RCT of fair quality, unadjusted risk estimates for presence of urinary incontinence or erectile dysfunction from cohort studies | Moderate | Limited information provided on specific surgical techniques evaluated | Prostatectomy was associated with increased risk for urinary incontinence compared with watchful waiting in 1 RCT (RR, 2.3 [CI, 1.6–3.2]; risk difference, 28%) and 4 cohort studies (median RR, 4.0 [range, 2.0–11]; median risk difference, 18 percentage points [range, 8–40 percentage points]). On the basis of large databases and surgical series, prostatectomy was associated with risk for perioperative death (about 0.5%) and cardiovascular events (0.6%–3%). Prostatectomy was not associated with worse outcomes on SF-36 summary component scores and most SF-36 subscales. |
| Radiation therapy | ||||
| 14 studies: 1 RCT;
13 cohort studies
Overall quality: fair |
Only 2 RCTs, unadjusted risk estimates for presence of urinary incontinence or erectile dysfunction from cohort studies | Moderate | Limited information provided on specific radiation therapy techniques and regimens evaluated | Radiation therapy was associated with increased risk for erectile dysfunction compared with watchful waiting in 6 cohort studies (median RR, 1.3 [range, 1.1–1.5]). Risk for urinary incontinence was increased in 1 RCT with a very imprecise estimate (RR, 8.3 [CI, 1.1–63]), but not in 4 cohort studies (median RR, 1.1 [range, 0.71–2.0]). Radiation therapy was also associated with an increased risk for bowel dysfunction, which appeared to improve over time. Radiation therapy was not associated with worse outcomes on SF-36 summary component scores and most SF-36 subscales. |
ERSPC = European Randomized Study of Screening for Prostate Cancer; HR = hazard ratio; KQ = key question; PLCO = Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; PSA = prostate-specific antigen; RCT = randomized, controlled trial; RR = relative risk; SF-36 = Short-Form 36.
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